Summary
Overview
Work History
Education
Skills
Certification
Languages
References
Timeline
Generic
KIMBERLY S. TURNER, MSc

KIMBERLY S. TURNER, MSc

OLATHE,KANSAS

Summary

Dynamic SR Clinical Trial Manager with more than 20 years of experience in the industry. With 6 years in the role of Clinical Trial Manager (or a similar position) and 11 years as a Clinical Research Associate, I have effectively overseen and executed numerous clinical research programs, ranging from First-in-Human Phase I studies to late-stage Phase IV trials across various therapeutic areas, including both device and drug trials. I have a proven track record of leading cross-functional teams, ensuring compliance with regulatory requirements, and delivering high-quality results within set timelines and budgets. My expertise includes clinical trial management, vendor oversight, risk assessment, and prioritizing patient safety. I have experience in directing CRA teams, developing project strategies, and implementing process improvements that enhance trial efficiency and outcomes. I am recognized for fostering collaborative work environments, maintaining rigorous ethical standards, and driving innovative solutions to complex challenges.

Overview

31
31
years of professional experience
1
1
Certification

Work History

Site Mnitoring Leader (SML

CRN Consultant (Boehringer-Ingelheim)
Remote, KS
02.2025 - Current
  • Accountable for the execution of close-out and overall quality of monitoring performed by FSP CRAs for assigned US trials (3), in early phase FIH oncology.
  • Provide CRA oversight and FSPM escalation for assigned trials.
  • Implement the monitoring plan as part of the Trial Team, and monitor clinical monitoring deliverables in clinical operations systems.
  • Deliver risk-based site monitoring approaches, and provide local training for the trial close-out visits.
  • Develop and deliver appropriate training for local trial teams, including Clinical Trial Managers (CT Managers), and Clinical Research Associates (CRAs).
  • Assist with in-house site monitoring, inspection readiness activities, and lead review and preparation for U.S. site regulatory inspections.
  • Serve as the local expert and consultant on site management and monitoring topics.
  • Participate in, and contribute status updates on, all assigned trials to global and regional meetings.
  • Provide timely responses to site management and monitoring questions from internal stakeholders, including regulatory authorities, and ethics committees.
  • Manage ICF, protocol amendments, and subject-facing document approvals for each site.
  • Tracking of site data entry and the status of subject re-consent prior to requesting the CRA to schedule close-out visits for parent trials and the conduct of SIVs for rollover to the final trial in the program.
  • Responsible for sending thank-you notes to all subjects in LTFU in parent trials that did not qualify for rollover due to progressive disease, subject withdrawal, or investigator decision.

SR Clinical Lead (CTM) & CRA Line Manager

ProPharma formerly Treximo
Remote, KS
09.2020 - 11.2024

Clinical Trial Management Role:

  • Oversee the implementation, execution, and closure of all components of the study operational plan.
  • Ensure compliance with all SOPs, regulatory guidelines, GCP, ICH, and other applicable regulatory requirements.
  • Manage and monitor assigned study(s), ensuring adherence to the study budget and timelines.
  • Develop and execute risk mitigation strategies throughout the study lifecycle.
  • Manage vendor relationships, and incorporate feedback from key stakeholders to optimize study operations.
  • Facilitate effective communication and collaboration within the clinical team.
  • Process and integrate input from key stakeholders as necessary for study success.
  • Conduct and ensure compliance with study-specific training for the clinical team.
  • Review monitoring visit reports to ensure quality and regulatory compliance.
  • Assure quality and monitor performance metrics for all aspects of the study.
  • Develop and maintain study tools and resources for the monitoring team.
  • Promote and implement continuous process improvement initiatives.
  • Provide oversight to ensure all trial documentation in the electronic Trial Master File is accurate and up to date.
  • Manage vendor relationships by actively incorporating feedback from key stakeholders to optimize and enhance clinical study processes.
  • Oversee the planning, execution, and management of clinical trials from start-up through close-out, ensuring adherence to all regulatory requirements, GCP/ICH guidelines, and SOPs.
  • Lead cross-functional study teams, including CRAs, vendors, and investigators, to achieve project milestones and study objectives.
  • Develop and implement study protocols, informed consent forms, monitoring plans, and essential trial documentation.
  • Manage site feasibility, selection, activation, and ongoing site support throughout the trial lifecycle.
  • Oversee vendor management, including selection, contracting, performance oversight, and issue resolution.
  • Track study timelines, budgets, and key performance indicators, proactively identifying and mitigating risks to ensure on-time and within-budget delivery.
  • Review monitoring visit reports, data quality, and regulatory compliance at trial sites; serve as the escalation point for study-related issues.
  • Coordinate and lead investigator meetings, team meetings, and regular study updates for internal and external stakeholders.
  • Participate in protocol development, feasibility assessments, and study design review from an operational perspective.
  • Support study budget and timeline management, contributing to risk mitigation strategies, and continuous process improvement.
  • Ensure accurate and complete maintenance of the Trial Master File (TMF) and all study records for inspection readiness.
  • Train, mentor, and supervise clinical trial personnel, including CRAs and CTAs, and foster a collaborative team environment.
  • Support regulatory submissions, audit preparation, and responses to regulatory inquiries as needed.
  • Drive process improvements and operational efficiencies to enhance trial quality and outcomes.
  • Serve as the primary point of contact for trial-specific questions, deliverables, and communications with sponsors, vendors, and site staff.

CRA Monitoring Management Role:

  • Oversee, plan, initiate, and execute clinical monitoring programs, ensuring high performance and quality of monitoring by CRAs and clinical operations staff.
  • Provide support to study teams in resourcing and allocating CRAs and CTAs for planned and ongoing clinical trials, based on staff experience and training.
  • Supervise, mentor, and manage CRAs and junior staff, including performance assessments, coaching, professional development, and conducting regular 1:1 and group meetings.
  • Participate in the hiring, onboarding, and training of new CRAs and CTAs, ensuring that staff are qualified and trained to meet study requirements.
  • Monitor CRA performance through the review of monitoring activities, trip reports, compliance with monitoring plans, key workload, and quality KPI metrics for bi-annual and annual review periods.
  • Conduct accompanied or co-monitoring visits to assess CRA skills and ensure quality standards are met.
  • Address site issues, escalate findings, and propose or implement corrective and preventive action plans (CAPAs) as needed.
  • Ensure adherence to ICH-GCP, SOPs, regulatory guidelines, and local regulations across all clinical trial activities.
  • Collaborate with Clinical Leads, Project Managers, and other stakeholders to manage project delivery, address challenges, and support study objectives.
  • Contribute to study/program plans, including monitoring plans, resource planning, and support for process improvement initiatives.
  • Maintain regular communication with internal and external stakeholders, providing updates, and reporting or escalating issues as necessary.
  • Review and approve itineraries, expense reports, and visit reports; manage vacation and leave requests for direct reports.
  • Ensure proper documentation, TMF management, and compliance with audit and inspection readiness standards.
  • Lead or support the development and delivery of CRA training programs and operational initiatives.
  • Foster a culture of collaboration, continuous improvement, and innovation within the monitoring team.

SR CRA (Consultant)

KST Clinical Research Consulting / MUSC
Remote, Kansas
04.2020 - 09.2020
  • Provided oversight for all study activities, ensuring compliance with GCP/ICH and GLPs.
  • Verified informed consent processes and assessed participant eligibility to ensure protocol adherence.
  • Reviewed and uploaded site IRB/IEC submissions to eTMF while tracking approvals.
  • Managed accountability for specimen and investigational product handling.
  • Submitted trip reports and site follow-up letters within established timelines.
  • Enhanced team communication to foster a collaborative work environment.
  • Reviewed source documents and data entries to confirm patient safety and data accuracy.

SR Clinical Trial Manager (Consultant)

KST Clinical Research Consulting / KPS Life
Remote, Kansas
10.2019 - 04.2020
  • Oversee the planning, execution, and management of clinical trials from start-up through close-out, ensuring adherence to all regulatory requirements, GCP/ICH guidelines, and SOPs.
  • Lead cross-functional study teams, including CRAs, vendors, and investigators, to achieve project milestones and study objectives.
  • Develop and implement study protocols, informed consent forms, monitoring plans, and essential trial documentation.
  • Manage site feasibility, selection, activation, and ongoing site support throughout the trial lifecycle.
  • Oversee vendor management, including selection, contracting, performance oversight, and issue resolution.
  • Track study timelines, budgets, and key performance indicators, proactively identifying and mitigating risks to ensure on-time and within-budget delivery.
  • Review monitoring visit reports, data quality, and regulatory compliance at trial sites; serve as the escalation point for study-related issues.
  • Coordinate and lead investigator meetings, team meetings, and regular study updates for internal and external stakeholders.
  • Ensure accurate and complete maintenance of the Trial Master File (TMF) and all study records for inspection readiness.
  • Train, mentor, and supervise clinical trial personnel, including CRAs and CTAs, and foster a collaborative team environment.
  • Support regulatory submissions, audit preparation, and responses to regulatory inquiries as needed.
  • Drive process improvements and operational efficiencies to enhance trial quality and outcomes.
  • Serve as the primary point of contact for trial-specific questions, deliverables, and communications with sponsors, vendors, and site staff.

SR CRA (Consultant)

KST Clinical Research Consulting / Merck
Remote, Kansas
07.2018 - 10.2019
  • Oversee the implementation, execution, and closure of all components of the study operational plan.
  • Ensure compliance with all SOPs, regulatory guidelines, GCP, ICH, and other applicable regulatory requirements.
  • Manage and monitor the assigned study, ensuring adherence to the study budget and timelines.
  • Develop and execute risk mitigation strategies throughout the study lifecycle.
  • Manage vendor relationships, and incorporate feedback from key stakeholders to optimize study operations.
  • Facilitate effective communication and collaboration within the clinical team.
  • Process and integrate input from key stakeholders as necessary for study success.
  • Conduct and ensure compliance with study-specific training for the clinical team.
  • Review monitoring visit reports to ensure quality and regulatory compliance.
  • Assure quality and monitor performance metrics for all aspects of the study.
  • Develop and maintain study tools and resources for the monitoring team.
  • Promote and implement continuous process improvement initiatives.
  • Ensure all trial documentation in the electronic Trial Master File (eTMF) is accurate and up to date.
  • Manage vendor relationships by actively incorporating feedback from key stakeholders to optimize and enhance clinical study processes.
  • Serve as the primary site manager and main point of contact for assigned oncology clinical trial sites, overseeing site initiation, routine monitoring, and close-out activities.
  • Conduct site qualification, initiation, interim monitoring, and close-out visits to ensure compliance with study protocols, ICH-GCP, SOPs, and all applicable regulatory requirements.
  • Evaluate, select, and initiate clinical study sites, ensuring that sites are adequately trained and prepared for trial activities.
  • Monitor patient recruitment, informed consent, eligibility, enrollment, and retention, collaborating with sites to meet recruitment targets, and address challenges.
  • Review source documentation, case report forms (CRFs), and data entries for accuracy, completeness, and protocol compliance, ensuring data integrity, and patient safety.
  • Ensure timely collection, review, and maintenance of essential regulatory documents (e.g., TMF, ISF), and verify reconciliation with sponsor files.
  • Oversee investigational product (IP) accountability, storage, handling, and documentation at sites.
  • Identify, escalate, and resolve protocol deviations, quality issues, or site performance concerns, implementing corrective actions as needed.
  • Provide ongoing training, mentorship, and support to site staff on protocol requirements, study procedures, and regulatory updates.
  • Review and submit monitoring visit reports, follow-up letters, and other study documentation in accordance with timelines and quality standards.
  • Collaborate with cross-functional teams, vendors, and CROs to support study start-up, execution, and closeout, including vendor oversight as required.
  • Participate in protocol development, feasibility assessments, and study design review from an operational perspective.
  • Support study budget and timeline management, contributing to risk mitigation strategies, and continuous process improvement.
  • Maintain audit-ready trial documentation, and support preparation for audits and regulatory inspections.
  • · Travel regularly to clinical sites as required (typically 10-12 days/month or as needed)

SR Clinical Science Liaison

Mirati Therapeutics
Remote, Kansas
04.2017 - 07.2018
  • Build and maintain strategic, peer-to-peer relationships with key opinion leaders (KOLs), external experts, and healthcare professionals in assigned therapeutic areas.
  • Serve as a scientific and clinical resource, providing accurate, balanced, and up-to-date information on company products, disease states, and emerging research to external stakeholders.
  • Gather, analyze, and communicate medical and clinical insights from the field to inform internal medical strategy, research priorities, and evidence generation plans.
  • Support clinical development activities, including site identification, trial recruitment, and ongoing engagement with investigators for company-sponsored and investigator-initiated trials.
  • Provide scientific and technical input to internal teams, including brand teams, clinical development, and medical affairs, ensuring alignment with regulatory and compliance standards.
  • Deliver and facilitate clinical, scientific, and technical education to healthcare professionals, advisory boards, and at scientific congresses or meetings.
  • Identify and assess research opportunities, support evidence generation, and contribute to publication planning and medical education initiatives.
  • Review and develop scientific materials (e.g., slide decks, medical narratives), and ensure consistency and compliance with approved content.
  • Act as a primary liaison for investigator-initiated research proposals, and provide ongoing support to investigators.
  • Monitor and report on scientific trends, competitive intelligence, and unmet needs within the therapeutic area to guide company strategy.
  • Participate in cross-functional project teams, committees, and internal training to support medical strategies and operational excellence.
  • Ensure all activities comply with national laws, regulations, company policies, SOPs, and codes of conduct.
  • Represent the company at national, regional, and local scientific meetings, fostering professional relationships, and enhancing the company’s scientific credibility.

Clinical Research Consultant

KST Clinical Research Consulting
Remote, Kansas
12.2011 - 04.2017
  • Optimized resource allocation by strategically prioritizing tasks in alignment with project timelines and client expectations.
  • Maintained up-to-date knowledge of relevant technologies and industry best practices through continuous professional development.
  • Managed multiple simultaneous projects, consistently meeting deadlines while upholding patient safety, quality, and data accuracy.
  • Worked as an independent consultant in various clinical research roles, including:
  • Senior CRA, Kythera Biopharmaceuticals.
  • Clinical Line Manager, PRA.
  • Senior CRA, Celerion Healthy Subject Phase 1 Unit.
  • Senior CRA, Alta Sciences, Healthy Subject, Phase I Unit.
  • Senior CRA, Vince, and Associates Healthy Subject Phase I Unit.
  • Senior CRA, Lotus Clinical Research.
  • Senior CRA, PSI.
  • Lead CRA, KPS Life Sciences.
  • Senior CRA, Covance.
  • Clinical Site Engagement Liaison, UCB.
  • Senior CRA, Amgen.

Clinical Operations Manager, North America

DOCS Global, Part of the ICON Group
Remote, Kansas
10.2010 - 12.2011
  • Provided oversight, coordination, and administration of processes to ensure effective placement of contracted CRAs and CTAs within the ICON Group.
  • Led cross-functional teams across multiple regions to achieve project milestones and operational targets.
  • Oversaw the development and implementation of global operational strategies to ensure alignment with company objectives.
  • Managed a team of 34 CRA and CTA consultants placed within the ICON Group.
  • Conducted interviews and provided recommendations for prospective new consultants (CRAs) for ICON clinical trial programs.
  • Oversaw training and onboarding for new hires, and ensured ongoing professional development of staff.
  • Evaluated consultant performance against established KPIs and metrics through collaborative team feedback.
  • Conducted routine 1:1 consultant meetings and regular client meetings.
  • · Performed consultant performance evaluations and provided constructive feedback.
  • Reviewed, negotiated, and executed consultant contracts, and contract renewals.
  • Took the necessary disciplinary and corrective actions related to contractor performance as needed.
  • Ensured delivery of professional services to clients in accordance with contractual agreements, including adherence to study goals, metrics, scope, and budget.
  • Reviewed and authorized all timesheets and expense reports submitted by consultants.
  • Supported clients in effectively identifying and fulfilling their resource needs.
  • Facilitated the resolution of issues between clients and DOCS consultants.
  • Led the development of operational initiatives and process improvements.
  • Implemented a new time and expense system, enhancing efficiency for clients, and ensuring consistent, timely payroll and travel expense reimbursement for consultants.

SR CRA

ICON Clinical Research
Remote, Kansas
12.2009 - 10.2010
  • Perform remote and on-site visits for all visit types to ensure data integrity and subject safety.
  • Provide continuous training and guidance to site research staff regarding study protocols, systems, and trial procedures.
  • Efficiently utilize electronic systems, including EMR, EDC, eTMF, CTMS, and IXRS.
  • Conduct a risk review and analysis, implementing mitigation strategies as needed.
  • Collaborate with project and sponsor teams to support study objectives.
  • Adhere to all KPIs, SOPs, and study metrics to ensure high-quality trial conduct.
  • Foster motivation and build strong relationships with site investigators and research staff to support the sponsor's goal of becoming their preferred clinical research partner.
  • Collaborate with vendors, and oversee the delivery of their commitments.
  • Assist sites with maintaining trial documentation within the Investigator Site File (ISF).
  • Attend investigator meetings, and engage with site research staff to cultivate positive relationships.
  • Maintain diligent oversight for GCP, ICH, and regulatory compliance.
  • Provide support during internal audits and FDA inspections, as requested.
  • Manage investigational product (IP), and specimen handling and accountability.
  • Conduct root cause analyses to identify and resolve trends, preventing recurrence.
  • Perform site management activities to ensure site success, and maintain a continuous state of inspection readiness.
  • Act as the primary contact for assigned sites, facilitating efficient communication between the study team and the sites.
  • Perform oversight activities to assess monitoring quality, and train or mentor junior and/or new CRAs.
  • Promptly document monitoring activities in reports, meeting submission deadlines for finalization.
  • Ensure that Good Clinical Practices (GCPs) and regulations are consistently followed.
  • Contribute to site identification, drive site feasibility and qualification progress, and support site activation activities.
  • Lead site engagement initiatives and recruitment activities to meet target enrollment goals.

Global Clinical Lead

Trialynx
Remote, Kansas
12.2008 - 10.2009
  • Conduct Pre-Study Site Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) through trial completion in both the U.S. and Canada.
  • Verify that data entered into eCRFs is consistent with patient clinical notes and source documentation.
  • Ensure regulatory compliance at all stages of the trial.
  • Document site visit reports, and adhere to designated timelines for finalization.
  • File and collate trial documents and reports for study records.
  • Create and maintain the Trial Master File (TMF) in paper format.
  • Ensure all used and unused trial supplies and investigational products/devices are properly accounted for.
  • Create and implement study documents and site resources to support trial conduct.
  • Conduct global bi-weekly team calls to coordinate study activities.
  • Draft quarterly clinical trial newsletters to communicate study updates.

Assign CRA sites, maintain CRA metrics per KPIs, review visit reports for training purposes, conduct annual or biannual quality training, and document monthly CRA performance for annual merit increases.

Hold 1:1 calls with CRAs to discuss career path progression, performance, and provide oversight.

Participate in weekly leadership calls to align on study and team objectives.

Maintain and monitor two (2) sites as a Senior CRA to ensure quality, and stay attuned to real-time site activities for effective leadership.

Submit and track documents to the central IRB for regulatory compliance.

Routinely review, reconcile, and collect documents for the Investigator Site File (ISF), including IRB submissions, safety, and protocol deviation reporting, as applicable.

Manage data entry, resolve queries, and address action items efficiently.

Perform 100% source data verification (SDV), and apply risk-based monitoring models as appropriate.

Manage and track study FAQs to support site and team inquiries.

Manage and track submissions to the central reader/core lab for study assessments.

Develop and distribute study newsletters to keep stakeholders informed.

Organize and participate in Principal Investigator (PI) and Study Coordinator (SC) meetings.

Liaise with Medical Science Liaisons (MSLs) for site visits and scientific support.

SR CRA

Abraxis Bioscience
Remote, Kansas
10.2007 - 12.2008
  • Conduct on-site and remote monitoring visits at trial locations to review regulatory documentation, drug storage procedures, equipment calibrations, and identify any deficiencies or training issues.
  • Monitor patient recruitment and enrollment numbers; recommend, and assist with recruitment strategies to meet study targets.
  • Review complex datasets and information from trial sites related to safety and efficacy, ensuring accuracy and completeness.
  • Write visit reports, summaries, and other central documents to capture key trial information, ensuring submission timelines are met.
  • Serve as the main point of contact for questions, issues, or feedback from site personnel; provide guidance, and leadership.
  • Track site performance benchmarks and metrics related to enrollment, data quality, and protocol adherence.
  • Develop solutions for operational challenges as they arise, and adjust plans to minimize the impact on trial execution.
  • Ensure ethical guidelines, safety regulations, and Good Clinical Practice (GCP) principles are strictly followed at all trial locations.
  • Represent trials and sponsor companies at investigator meetings, conferences, and training sessions.
  • · Lead or assist sponsor companies with final analysis, evaluation, and conclusions of trial data.
  • Prepare sites and systems for regulatory inspections, and participate in or present during inspections as needed.
  • Maintain expert-level knowledge of regulations, guidelines, and systems related to drug and device trials.
  • Perform quality assurance audits on CRA monitoring activities and site performance.
  • Demonstrate leadership skills to manage teams, provide excellent customer service to sites, and troubleshoot complex issues.
  • Exhibit outstanding project management abilities to coordinate multiple trial details, and manage competing timelines.
  • Maintain meticulous attention to detail regarding data, documentation, and protocols.
  • Communicate effectively in writing and verbally to draft summaries, reports, emails, and other correspondence for various stakeholders.
  • Apply strong analytical and critical thinking skills to analyze data, reports, and processes, identifying potential improvements.

CRA / Project Lead

Eli Lilly and Company
Remote, Kansas
12.2006 - 10.2007
  • CRA Lead for U.S. Oncology sites at the request of U.S. Oncology.
  • Skills in clinical knowledge, medicine, physiology, and related scientific fields.
  • Fluency and literacy in interpreting medical and clinical trial documentation.
  • Proficiency in CDC principles of Good Clinical Practice.
  • Excellent organizational skills to manage multiple priorities and deadlines.
  • Ability to maintain compliance across all trial systems and documentation.
  • Willingness and ability to travel frequently to sites across the country.
  • Organize and assign duties and tasks to clinical team members.
  • Monitor the daily performance of clinical team members to ensure that duties are completed accurately, efficiently, and in a timely manner.
  • Monitor and control overtime.
  • Assist with, or conduct, periodic staff meetings with clinical team members.
  • Attend clinical meetings and relay pertinent information to clinical team members in a timely manner.
  • Meticulous attention to detail regarding data, documentation, protocols compliance, etc.
  • Excellent written and verbal communication skills for drafting summaries, reports, emails, etc.
  • Review complex datasets and information from trial sites related to safety and efficacy, and ensure accuracy and completeness.
  • Write visit reports, summaries, and other central documents to capture key trial information, ensuring submission timelines are met.
  • Serve as the main point of contact for questions, issues, or feedback from site personnel; provide guidance and leadership.

In-House CRA

United BioSource
Kansas City, MO
07.2006 - 12.2006
  • Provide support to the project PM and field-based CRA team as needed.
  • Maintain regulatory documentation in the Trial Master File (TMF) for assigned sites.
  • Possess a solid understanding of study protocols and requirements relevant to assigned projects.
  • Receive and evaluate data collection (paper CRFs) for completeness, clarity, and identification of potential unreported Serious Adverse Events (SAEs).
  • Ensure adherence to critical study timelines and project milestones.
  • Promptly notify the safety team upon the identification of any unreported SAEs.
  • Monitor participant enrollment status, and manage inventory of drug/study supplies, facilitating timely re-supply processes.
  • Engage daily with IVR systems to track enrollment, manage drug supplies, and generate ad hoc reports for the team.
  • Collaborate regularly with IVR vendors to implement corrective measures in the IVR system, as needed.
  • Provide assistance in resolving clinical and supply chain challenges.
  • Participate in teleconferences, meetings, and investigator gatherings as required by the study team.
  • Duplicate regulatory files for closeout visits to ensure comprehensive on-site reconciliation by field CRAs.
  • Reach out to prospective investigator sites as part of the site identification and feasibility processes.
  • Updated and maintained databases with current information.
  • Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
  • Conducted comprehensive research and data analysis to support strategic planning and informed decision-making.

Clinical Research Study Coordinator

Kansas City Allergy & Asthma
Overland Park, Kansas
08.2005 - 07.2006
  • Primary coordinator for asthma, allergy, and immunology trials in both adult and pediatric populations.
  • Worked closely with the investigator in the identification of patients, obtaining consent, assent, reconsent, performing screening procedures to determine eligibility, and enrollment or randomization of patients.
  • Safeguard patient private health information in compliance with HIPAA regulations.
  • Preparation and administration of investigational medications.
  • Obtain the application information sheet to outline the study staff's experience and skill set based on therapeutic experience.
  • Manage the inventory of investigational products, provide study equipment, lab kits, and necessary ancillary study supplies.
  • Attend investigator meetings.
  • Ensure compliance with ICH/GCPs, GLPs, IRB regulations, requirements, and OSHA standards.
  • Submit initial and annual study reviews.
  • Comply with facility SOPs, and training requirements.
  • Completion of all study-required training and gaining access to IVRS, EDC, and any applicable shared platforms designated by the sponsor.
  • Scheduling all CRA visits, correcting or resolving any issues noted, routinely reviewing and resolving action items, opening queries, and/or addressing missing pages during the study, as well as providing title responses during interim analysis or database lock events.
  • Ensure investigators' timely review and assessment of lab results, or other patient testing, required by the protocol.
  • Maintenance of the ISF.
  • SAEs, submission to the IRB, and notification to the Sponsor within required timelines, and follow up to resolution.
  • Coordinate multiple studies concurrently while maintaining all associated responsibilities and activities, as required.
  • Meet with investigators weekly to provide study status updates.
  • Organize and conduct regular staff meetings for improved collaboration, enhanced patient care, and client satisfaction.
  • Managed subject recruitment efforts (advertising), resulting in a diverse participant pool.
  • Collected, processed, and shipped lab specimens.
  • Maintain all routine study logs as required.

Junior Research Coordinator Medical Assistant

Mid-America Cardiology (Kansas University Medical Center)
Kansas City, Kansas
02.2004 - 08.2005
  • Assist in the recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility for cardiology clinical trials.
  • Prepare patients for examinations and cardiac procedures, including taking vital signs, recording medical histories, and ensuring patient comfort.
  • Conduct and assist with diagnostic cardiac tests, such as electrocardiograms (EKGs), stress tests, Holter monitoring, and other heart function assessments, under physician guidance.
  • Administer study medications and perform patient assessments during study visits, monitoring for side effects, and promptly notifying the principal investigator of any findings.
  • Maintain regulatory and study documentation, including accurate and timely data collection, entry into electronic case report forms (eCRFs), and management of study records and logs.
  • Support the principal investigator and research team in protocol implementation, ensuring compliance with research protocols, Good Clinical Practice (GCP), ICH, IRB, and HIPAA regulations.
  • Educate patients and their families about study procedures, cardiac health, medication management, and post-procedure care to ensure understanding and protocol adherence.
  • Prepare and maintain procedure rooms, sterilize equipment, and ensure all necessary supplies and materials are available and ready for cardiac procedures.
  • Assist during cardiac procedures by passing instruments, applying dressings, monitoring patient status, and maintaining a sterile field throughout the procedure.
  • Collect, process, and prepare laboratory specimens and diagnostic tests for transport, ensuring proper labeling and documentation.
  • Manage scheduling, coordinate patient appointments, and handle administrative tasks such as billing, insurance coding, and correspondence to support clinical trial operations.
  • Monitor participant enrollment status, manage the inventory of investigational products and study supplies, and facilitate re-supply as needed.
  • Ensure compliance with all safety and ethical guidelines, and maintain patient confidentiality in accordance with HIPAA and institutional policies.
  • Participate in study meetings, training sessions, and ongoing communication with the research team to support trial progress and address operational challenges.
  • Assist with data review, query resolution, and quality assurance activities to ensure data integrity and protocol compliance.

Lab Technician / Phlebotomist

Providence Medical Center
Kansas City, Kansas
01.2002 - 01.2002
  • Collect blood and other biological specimens (urine, tissue, etc.). From patients using venipuncture, capillary collection, or other approved methods, ensuring proper patient identification and comfort.
  • Prepare, label, and process samples for laboratory testing, ensuring correct handling, storage, and transport to maintain sample integrity.
  • Explain procedures to patients, address concerns, and provide reassurance, especially for those who are nervous about needles.
  • Perform and assist with laboratory tests and analyses, including microscopic, bacteriological, hematological, immunologic, and chemical diagnostic tests.
  • Maintain accurate and detailed records of patient information, test results, and sample documentation in laboratory information systems.
  • Forward test results to physicians and other healthcare providers for diagnosis and treatment planning.
  • Calibrate, operate, and maintain laboratory equipment, ensuring all instruments are functioning correctly and safely.
  • Prepare laboratory reagents and standard solutions for testing purposes.
  • Adhere to safety protocols, including proper disposal of contaminated supplies, sterilization of equipment, and compliance with OSHA, and other regulatory standards.
  • Maintain a clean, safe, and organized work environment, restocking supplies as needed.
  • Participate in quality control and assurance activities, standardizing procedures, and ensuring consistency and reliability of results.
  • Monitor the inventory of laboratory and phlebotomy supplies, ordering and replenishing as necessary.
  • Assist with administrative tasks such as updating patient medical records, billing documentation, and laboratory requisitioning.
  • Support other laboratory staff and healthcare team members, providing technical assistance, and collaborating on patient care.
  • Participate in ongoing education and training to stay current with laboratory techniques, safety protocols, and scientific developments.

Patient Care Technician – Cardiac Unit Float Pool

St. Luke’s Hospital
Kansas City, MO
01.2000 - 01.2002
  • Assist registered nurses (RNs) and licensed practical nurses (LPNs) in providing safe, effective, and efficient patient care as directed, specifically within the cardiac unit, and across multiple hospital units as part of the float pool.
  • Collect and record patient data, including vital signs, height, weight, oxygen saturation, intake/output, and blood glucose monitoring, reporting abnormal findings to the nurse.
  • Support patients with activities of daily living, such as bathing, grooming, oral care, feeding, toileting, and ambulation, including the use of mobility aids (walkers, wheelchairs, etc.).
  • Assist with patient positioning, repositioning, transferring, and safe use of equipment (bed alarms, side rails, trapeze, restraints), using proper body mechanics.
  • Monitor patients for special risks (e.g., falls, skin breakdown), and promptly report observations or changes in patient condition to the assigned nurse.
  • Maintain and document regulatory and safety measures according to unit and hospital standards, including infection control, and proper use of personal protective equipment (PPE).
  • Maintain a clean, organized, and safe environment for patients and staff; stock and return equipment and supplies as needed.
  • Collect urine and stool specimens as ordered, and ensure proper labeling and delivery to the laboratory.
  • Respond promptly to patient needs and requests, making regular patient rounds to ensure timely care and comfort.
  • Orient patients to the care environment, and provide emotional support to promote patient comfort and safety.
  • Document all care provided and observations completely and accurately in the patient record.
  • Assist with the admission, transfer, and discharge process for patients, including the preparation of rooms and equipment.
  • Participate in emergency situations by following appropriate guidelines, and assisting the healthcare team as needed.
  • Communicate effectively and professionally with patients, families, and the healthcare team, maintaining confidentiality at all times.
  • Attend and participate in staff meetings, in-services, and ongoing education to maintain competency and support unit needs.
  • Float to various units as assigned, adapting to different patient populations and care requirements as needed.

Medical Assistant

Dr. Henry Tsumo Tai, Hematology and Oncology
Montebello, CA
03.1994 - 03.1999
  • Sanitized, restocked, and organized exam rooms and medical equipment supplies.
  • Obtained client medical history, medication information, symptoms, and allergies.
  • Directed patients to exam rooms, fielded questions, and performed assessments; collected standard of care and routine labs for physician examinations.
  • Managed medical records, including filing, organizing, and scanning documents.
  • Built strong relationships with patients through effective communication, fostering trust in the clinic’s commitment to quality care.
  • Collected blood and performed manual testing for PT, PTT, and INR in-house for doctor review.
  • Collected blood and performed CBC with differential testing in-house using the J T2 Coulter for doctor review.
  • Collected and processed all Chem 12 panels in-house for doctor review.
  • Maintained current CAP/CLIA certifications for the in-house laboratory.
  • Tracked and ordered all in-house medications and blood testing equipment reagents for lab testing.
  • Assisted the doctor during patient examinations.
  • Reviewed lab results, highlighting any values outside the normal range for doctor review.
  • Communicated test results to patients, and provided follow-up actions as ordered by the doctor.
  • Instructed patients on heparin and warfarin dose adjustments, and educated them on signs and symptoms requiring doctor notification.
  • Phoned in patient prescriptions and refills to the pharmacy.
  • Prepared patient medication for in-clinic dosing.
  • Prepared and administered patient injections (e.g., Filgrastim, Epoetin, annual vaccines).
  • Scheduled patient diagnostic, surgical, and follow-up procedures.
  • Created and maintained patient charts.
  • Held weekly meetings with the doctor to discuss the upcoming schedule, procedures, and any ad hoc tasks for completion.

Education

Doctor of Health Science - Health Services Administration

Purdue Global University
West Lafayette, IN
06.2026

Master of Science - Health and Human Performance

Fort Hays State University
Hays, KS
12.2011

Bachelor of Health Science - Health Services Administration

Washburn University
Topeka, KS
12.2006

Associate in Applied Science -

Kansas City Community College
Kansas City, KS
08.2004

Certified Medical Assistant -

Nova Institute of Health Technology
Kansas City, KS
01.2000

Skills

  • Communication
  • Analytical thinking and problem-solving skills
  • Empowering leadership
  • Management proficiency
  • Adaptability
  • Clinical trials expertise
  • Meticulous attention to detail
  • Clinical trial management
  • Regulatory compliance
  • Data analysis
  • Patient recruitment
  • Cross-functional collaboration
  • Effective communication
  • Time management
  • Team leadership
  • Quality assurance controls
  • Goal setting
  • KPI development
  • Change management
  • Stakeholder engagement
  • Talent development
  • Performance management
  • Conflict resolution
  • Recruitment and hiring
  • Strategic planning
  • Line management
  • Team building
  • Contract oversight
  • Motivating teams
  • Task delegation
  • Process monitoring and improvement
  • Verbal and written communication
  • Quality control
  • Staff education

Certification

Project Management Certificate

Coursera

April 2025

  • Foundations of Project Management
  • Project Initiation: Starting a Successful Project
  • Project Planning: Putting It All Together
  • Project Execution: Running the Project
  • Agile Project Management
  • Capstone: Applying Project o Management in the Real World

ISO14155 Certificate

Clinical Pathways

04April 2025

GCP/ICH Certificate

NIDA Clinical Trials Network

01April 2024 to 01Apr2027

ECG Techniques & Phlebotomy Certificates

05January 2000

Languages

English
Native/ Bilingual

References

References available upon request.

Timeline

Site Mnitoring Leader (SML

CRN Consultant (Boehringer-Ingelheim)
02.2025 - Current

SR Clinical Lead (CTM) & CRA Line Manager

ProPharma formerly Treximo
09.2020 - 11.2024

SR CRA (Consultant)

KST Clinical Research Consulting / MUSC
04.2020 - 09.2020

SR Clinical Trial Manager (Consultant)

KST Clinical Research Consulting / KPS Life
10.2019 - 04.2020

SR CRA (Consultant)

KST Clinical Research Consulting / Merck
07.2018 - 10.2019

SR Clinical Science Liaison

Mirati Therapeutics
04.2017 - 07.2018

Clinical Research Consultant

KST Clinical Research Consulting
12.2011 - 04.2017

Clinical Operations Manager, North America

DOCS Global, Part of the ICON Group
10.2010 - 12.2011

SR CRA

ICON Clinical Research
12.2009 - 10.2010

Global Clinical Lead

Trialynx
12.2008 - 10.2009

SR CRA

Abraxis Bioscience
10.2007 - 12.2008

CRA / Project Lead

Eli Lilly and Company
12.2006 - 10.2007

In-House CRA

United BioSource
07.2006 - 12.2006

Clinical Research Study Coordinator

Kansas City Allergy & Asthma
08.2005 - 07.2006

Junior Research Coordinator Medical Assistant

Mid-America Cardiology (Kansas University Medical Center)
02.2004 - 08.2005

Lab Technician / Phlebotomist

Providence Medical Center
01.2002 - 01.2002

Patient Care Technician – Cardiac Unit Float Pool

St. Luke’s Hospital
01.2000 - 01.2002

Medical Assistant

Dr. Henry Tsumo Tai, Hematology and Oncology
03.1994 - 03.1999

Doctor of Health Science - Health Services Administration

Purdue Global University

Master of Science - Health and Human Performance

Fort Hays State University

Bachelor of Health Science - Health Services Administration

Washburn University

Associate in Applied Science -

Kansas City Community College

Certified Medical Assistant -

Nova Institute of Health Technology
KIMBERLY S. TURNER, MSc