Allan W. Malinda
Olathe,KS
Summary
Experienced Senior Clinical Research Coordinator with a proven track record in successfully managing Early and Late Phase Clinical Research Projects. Seeking an opportunity to advance my career with an organization that values dedication and is committed to being at the forefront of the drug development field. Strong work ethic, attention to detail, and a passion for driving innovation in the industry. Collaborate to make a meaningful impact on patient outcomes and contribute to the advancement of medical research.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator- Asthma, Allergies & Vaccines
Velocity Clinical Research
02.2024 - Current
- Implemented and coordinated assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close outreach reports
- Utilized and applied project management concepts to manage risk and improve quality in the conduct of each assigned clinical research study
- Communicated effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
- Created, collected and submitted regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements
- Created and executed recruitment strategies defined by Clinical Research Team, including working with centralized recruitment companies such as StudyKik, Citeline, and Clinago
Clinical Research Coordinator- Hematology Oncology
HCA Midwest Health
09.2022 - 02.2024
- Supported enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements
- Reviews the study design and inclusion/exclusion criteria with physicians and patients
- Ensured the protection of study patients by verifying informed consent procedures and adhering to protocol requirements
- Collected, completed, and entered data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines
- Ensured the integrity of the data submitted on case report forms or other data collection tools by careful source document review; monitored all collected data for missing or implausible errors
- Ensured that adequate and accurate records are maintained for inspecting
Snr Clinical Research Coordinator- Late Phase Trials
University of Kansas Cancer Center
05.2020 - 09.2022
- Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials
- Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials
- Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors
- Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice
- As requested, facilitate monitoring visits, reviews, and audits
- Provide written and verbal reports to Principal Investigator and Project Manager, as required
- Prepare and maintain clinical trial contract documents and study budget reports
- Perform study procedures, as outlined in the protocol and within state and institutional scope of practice
- Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy
- Ensure adequate study supplies are being maintained
- Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants
- Prepare documentation and participate in study monitoring visits, reviews, and audits
- Provide written and verbal reports to Principal Investigator and Project Manager, as required
- Attend continuing education, research and training seminars as requested by manager
- Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria, and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR
- Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures
- Reviews and assists with editing of new protocols
- Assesses feasibility of research protocol including appropriate patient population, budget, and specific needs for the study
- Assist Principal Investigators with internal and external funding application submissions
- Other relevant duties as requested by the supervisor
Correlative Laboratory Manager- Late Phase Trials
University of Kansas Cancer Center
02.2019 - 05.2020
- Support with Management for all day-to-day activities in four correlative labs across KUMC campuses
- Have in-depth knowledge of specimen collection, processing, and shipping requirements for all active protocols within the cancer center clinical trial network
- Assist the Director of Correlative Labs with management of disposal of bio-hazardous materials, chemical waste, sharps, and other hazardous materials according to policy and strictly adhere to safety and infection control procedures
- Closely collaborate with laboratory and research staff, treatment area nurses, pathology, and tissue repository staff to assure all project personnel are aware of and trained in sample collection/processing needs for the study
- Provide support to the Director of Correlative Labs to ensure that all lab equipment is calibrated, maintained and operable and keeps appropriate documentation
- Ensures the accurate inventory of study lab kits and shipping materials at all three research lab locations
- Review the lab requirements of prospective trials and discuss with the Executive Review Committee (ERC) in the Absence of the Director of Correlative Labs
- Actively participate in Project Director, Departmental, Coordinator, Team and Staff meetings
- Accomplish project goals through effective team leadership
- Provide support to the Director of Correlative Labs to ensure that all lab equipment is calibrated, maintained and operable and keeps appropriate documentation
- Ensures the accurate inventory of study lab kits and shipping materials at all three research lab locations
- Assist the Director of Correlative Labs with writing SOP’S and Guidance Documents for the CTO Lab to improve quality assurance and create a standard process for lab operation
Senior Lab Coordinator
University of Kansas Cancer Center
09.2016 - 02.2019
- Responsible for coordination of multiple clinical trial study specimens and supplies per protocol requirements
- This includes pharmacokinetics, pharmacogenomics and all studies required for Industry Sponsored, Cooperative Group and Investigator Initiates clinical Trials
- Bridge between Research and Clinical staff, to ensure the correct samples are being collected from our patient
- Meet with Sponsors and Monitors, to make sure our department has all necessary tools and equipment needed to perform our duties
- Keep up with inventory for multiple clinical trials daily
Laboratory Manager
Vince & Associates Clinical Research
05.2013 - 09.2016
- Maintain medical laboratory equipment performance by establishing quality standards, developing operations, quality, and troubleshooting procedures, ensuring staff compliance, certifying instrument performance, arranging equipment replacement, service, and repair
- Maintain medical laboratory supplies by checking stock to determine inventory level, anticipating needed supplies, placing and expediting orders for supplies, verifying receipt of supplies
- Maintain medical laboratory productivity by monitoring workload of functional areas, making operational or staffing adjustment depending on workload
- Maintain quality results by reviewing quality control and quality assurance programs, making adjustments in policy and procedures, generating reports, maintaining records
- Writing user manuals, and work instructions, training employees, maintaining security and confidentiality of Lab related documents
- Maintain medical laboratory staff by recruiting, selecting, orienting, and training employees
- Completes operational requirements by scheduling and assigning employees, following up on work results
- Provides administrative support for the clinic by acting as manager on call
- Contributes to team effort by accomplishing related results as needed
Education
University of Kansas
Lawrence, KSJohnson County Community College
Overland Park, KSSkills
- Study monitoring
- Data collection
- Patient recruitment
- Protocol development
- Trial oversight
- Phlebotomy
- Informed consent
- Trial management
- Site management
- Good clinical practices
- Medication dispensing
Accomplishments
- Collaborated with team of Principal Investigators in the development of Expanded/
Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide.
- Collaborated on a Phase 3 clinical trial evaluating the safety, effectiveness, and immune response of an investigational mRNA vaccine aimed at preventing norovirus disease in adults. One of the first of its kind.
Certification
- Licensed CPR Certification
- Certified ASCP Phlebotomist
Timeline
Senior Clinical Research Coordinator- Asthma, Allergies & Vaccines
Velocity Clinical Research
02.2024 - Current
Clinical Research Coordinator- Hematology Oncology
HCA Midwest Health
09.2022 - 02.2024
Snr Clinical Research Coordinator- Late Phase Trials
University of Kansas Cancer Center
05.2020 - 09.2022
Correlative Laboratory Manager- Late Phase Trials
University of Kansas Cancer Center
02.2019 - 05.2020
Senior Lab Coordinator
University of Kansas Cancer Center
09.2016 - 02.2019
Laboratory Manager
Vince & Associates Clinical Research
05.2013 - 09.2016
University of Kansas
Johnson County Community College
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