Summary
Overview
Work History
Education
Skills
Therapeutic Area Experience
System Experience
Timeline
Generic

MEGAN KALU

Dallas,TX

Summary

Dedicated Senior Clinical Research Associate with over 9 years of industry experience in site management and clinical research, with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best manage clinical trials. With an expertise in study/site start-up, execution/maintaince and close out of clinical trials in accordance with ICH-GCP regulations. Strengths in Oncology, Medical Device, Rare Disease, Infectious Disease, Ophthalmology, Endocrinology, CNS and Cardiovascular Disease and more backed by training in Good Clinical Practice.

Overview

10
10
years of professional experience

Work History

Clinical Trial Manager

Phanes Therapeutics
Dallas, Texas
04.2024 - Current
  • Reviews and approves confirmation letters, follow-up letters, and monitoring reports as part of the monitoring process for CRAs.
  • Oversees all aspects of the clinical trial startup process with minimal supervision, including the creation of Site Initiation Visit (SIV) and Pre-Site Selection Visit training materials used to educate and prepare site staff.
  • Leads investigator meetings to ensure clear communication, protocol adherence, trial updates for site staff, and investigators.
  • Reviews and approves site budgets and contracts while managing study financials, including budget negotiations, forecasting, assumptions, invoices, and reconciliation.
  • Responsible for developing study documents including all plans (Clinical Monitoring Plans, Protocol deviation plan, Trial Master File Plan), Annotated monitoring templates, ICFs (Informed Consent Forms).
  • Performed SIVs and Pre-Site Selection visits as needed
  • Responsible for retrieval, review, and analysis of clinical data.
  • Responsible for operational aspects of trials, EDC status, eTMF management, tracking regulatory documentation, and trial-related materials such as IP and laboratory sample management.
  • Ensures the successful conduct of clinical trials and oversees operational planning and execution to ensure all trial-related timelines are met, within program budget, and to qualify standards.
  • Manages study submissions to central IRB, ensuring deadlines.
  • Facilitates internal and external cross-functional meetings to provide study updates, which included site selection, enrollment, safety data, and key issues to stakeholders.
  • Participates in data management activities, including but not limited to managing EDC database updates related to protocol amendments, data cleaning, and validation.

Senior Clinical Research Associate

Phanes Therapeutics
Dallas, Texas
03.2023 - 04.2024
  • Conducted pre-study (site qualification), initiation, routine monitoring and closeout visits
    and ensured visits were completed according to the Clinical Monitoring Plans
    and SOPs.
  • Maintained the Trial Master File (TMF) and contributed to the creation of the filing structure and organization of the TMF system, ensuring accurate documentation and compliance with regulatory requirements.
  • Developed and reviewed regulatory documentation to support study start-up activities.
  • Trained the study investigators and staff during the SIV and trial-specific updates, all to industry standards.
  • Key contributor/developer of critical study documents (e.g., Protocol, ICF, SOPs, study plans, eCRFs, Monitoring reports ect.)
  • Verified data entered into the case report forms to ensure consistency with subject clinical records, electronic medical records, and source data for accuracy.
  • Ensured data collection timelines and deliverables were met at assigned clinical sites in accordance with study plans.
  • Worked with Data Management to ensure the query resolution process was followed and completed.
  • Identified and reported protocol deviations in accordance with the Protocol Deviation Plans, and monitors site submission to the IRB/EC per reporting policies.
  • Reviewed and Verified site payment workbooks to ensure accuracy and compliance before processing payments, minimizing errors and ensuring timely disbursement to clinical trial sites.
  • Ensured site compliance to SAE/SUSAR/DLTs reporting policy per protocol and with the Safety Management Plans.
  • Ensured site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites.
  • Assisted the CTM in the development and implementation of corrective actions for addressing non-compliance issues at individual sites and across the study, including timely follow-up to routine and for-cause Quality Assurance audits.
  • Tracked and reported progress of assigned sites, including study start-up, subject screening/enrollment, data collection, adverse event documentation, and Frequently Asked Questions document updates.
  • Provided oversight to direct and indirect reports.
  • Trained and mentored Junior CRAs on monitoring activities, protocol adherence, and regulatory compliance, company policy and expections to enhance their skills and ensure effective performance.
  • Collaborated with the CTM and CTAs on the development of certain study-specific plans and/or processes.
  • Participated in Clinical Trial / Clinical Development Team Meetings.

Senior Site Manager

Janssen Pharmaceuticals
Houston, TX
12.2021 - 12.2022
  • Assists in development and maintenance of necessary clinical documents (e.g., protocols, SOPs, design data collection forms, patient consent forms etc.)
  • Participate in site assessments, conduct pretrial site assessment visits and/or participate to study feasibility assessments, providing recommendations from local area about site/investigator selection in collaboration with the trial team.
  • Act as primary liaison for assigned sites for specific trials and work closely with Clinical Trial Manager and trial central team regarding study progress and issue resolution.
  • Trained new hire CRAs & study coordinators on the use of electronic case reporting forms.
  • Execute activities within site initiation and startup, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
  • Perform country/site feasibility and summarize information in a Country Feasibility Report
  • Ensure site staff maintains current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
  • Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Submit regulatory documents to the central IRB and Ensure the IRB receives all current documentation throughout the lifecycle of the study
  • Assists with regulatory folder management and maintenance (responsible for the correct
    filing and archiving of clinical trial documents, and the maintenance of study files).
  • Ensure site staff complete the data entry and resolve queries within expected timelines.
  • Ensure the retrieval, accuracy, validity and completeness of documentation collected at the site level.
  • Perform Annual quality review of site related regulatory documents in TMFImplementation of Analytical Risk Based Monitoring (ARBM) model at the site level. Monitor study progress at site using study specific systems and available reports/performance dashboards.
  • Ensure that all Adverse Events (AE)/Serious Adverse Events (SAE) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents

Senior Clinical Research Associate

Rho Inc
Houston, TX
04.2021 - 12.2021
  • Effectively managed multiple clinical studies/sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials while providing moderate level study management support.
  • Collaborated with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
  • Trained investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.
  • Evaluated actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
  • Assessed eCRFs for trends in safety, effectiveness, and adherence to protocol.
  • Performed on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:
  • Ensured that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File, and is accessible to investigative site personnel.
  • Ensured investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
  • Prepared, submit and file high quality monitoring visit reports and associated follow-up letters in a timely manner.
  • Maintained audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
  • Confirmed all equipment/supplies provided to investigative sites is appropriately reported to Study Manager.
  • Identified training needs, developing materials and conducting training on clinical, therapeutic and/or compliance topics.

Clinical Research Associate II

Rho Inc
Houston, TX
06.2019 - 04.2021
  • Monitored progress of clinical trails at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirement.
  • Verified informed consent procedure and study protocol procedures are in alignment with study
  • Ensured recruitment and retention of patients
  • Ensured protocol compliance, subject safety, and data integrity
  • Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents and issuing states reports
  • Obtained, review for appropriateness, and process regulatory and administrative documents from investigator sites
  • Participated in the maintain and lifecycle of site start up to execution in accordance to ICH-GCP regulations
  • Helped to prepare study-related documentation, provides input for the design of the ICF template, CRFs, monitored conventions, edit checks, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines etc.

Clinical Research Associate I

Merck Pharmaceuticals
Houston, TX
01.2017 - 06.2019
  • Oversaw the development of clinical trial protocols, participated in the development of the overall clinical plan, drafts protocols, collaborated on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies
  • Participated in the identification of potential investigators and clinical sites, both nationally and internationally; conducted pre-study site visits, collected and reviewed data, and prepared evaluative reports; participated in the final selection of investigators and study sites
  • Assisted in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities, and participates in final selection
  • Oversaw research technical and administrative staff, to include hiring, training, goal-setting, and distribution of workload
  • Assisted with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participated in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems
  • Conducted clinical trial site initiation visits; advised and trained site personnel on sponsor and regulatory requirements for study conduct; participated and conducted site meetings and multicenter investigator meetings and prepared reports
  • Conducted site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies
  • Reviewed on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identified deficiencies and discrepancies, and provides remedial training and initiated corrective action as required
  • Ensured appropriate transmission of clinical case data to the data management centers; reviewed case report queries and problems, and clarified and obtained changes to data as appropriate
  • Assisted in the termination of clinical studies by identifying items and issues for review and/or follow-up, assembled necessary documents, conducted site termination visits to include test article reconciliation and disposition

Clinical Trial Associate

Merck Pharmaceuticals
Houston, TX
01.2016 - 01.2017
  • Provided support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.
  • Worked with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
  • Performed departmental tasks.
  • Performed developmental tasks with oversight of CTA Manager.
  • Approval of study documentation, including essential document packets, study plans,
    informed consent forms, etc.
  • Supported oversight of risk-based monitoring.
  • Attended important team meetings.
  • Supported regulatory inspection readiness (e.g., preparation of materials and
    participation during regulatory inspections.)
  • Supported additional ad-hoc activities, as agreed with CTA Manager.
  • Worked with internal departments (Legal, Insurance, R&D functions), CROs, and
    vendors.
  • Escalated clinical trial insurance issues.
  • Supported Health Care Provider Engagement for facilitating contracts and meetings.
  • Supported vendor contract administration.

Clinical Research Coordinator

Baylor Scott and White
Houston, TX
01.2015 - 01.2016
  • Accountable for overseeing all aspects of clinical trials as it relates to local, state and/ or federal regulatory requirement.
  • Assisted PI in the preparation and submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB and other regulatory organizations
  • Managed regulatory documents and clinical trials manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts.
  • Completed safety reporting procedures according to regulatory compliance.
  • Maintained source documents and subject files in accordance with hospital procedures.
  • Collected, transported, processed and shipped blood samples in accordance with federal, state and institutional policies, as well as delineated in sponsor's protocol.
  • Assisted with preparation of data for statistician.
  • Developed ongoing reports for the Pl and CRM.
  • Initiated IRB applications for clinical trials.
  • Attended investigator and coordinator meetings.

Education

Bachelor of Science - Health Promotions, Biology Minor

University of Houston
Houston, TX
05.2015

Skills

  • Ability to work independently, including on-site travel
  • Energetic, dynamic, hands-on, and self-motivated
  • Ability to establish credibility, trust, and strong working relationships
  • Excellent interpersonal, communication, and organizational skills
  • Extensive knowledge of Good Clinical Practice (GCP)
  • Proven project management skills
  • Ability to manage multiple tasks simultaneously
  • Good verbal and written communication skills
  • Detail oriented and good problem-solving ability
  • Ability to work on teams and with multiple projects
  • Knowledge of medical terminology
  • Over 7 years of site management experience
  • Excellent computer skills (experience with spreadsheets and word processing programs)
  • Knowledge of GCP’s medical device regulations (21CFR, MDD/MDR), and other global regulations, standards, and guidance
  • Excellent at meeting timelines and maintaining budget management
  • Phases I-VI clinical trials experience
  • Proficient in utilizing integrated data analyzing systems to measure site and study performance

Therapeutic Area Experience

  • Medical Device: In Vitro Diagnostics and Non-IVD
  • CNS: Schizophrenia, Huntington’s Disease, Migraine, Bipolar Disorder, ADHD, Major Depressive Disorder, Pediatric Multiple Sclerosis and Parkinson’s Disease
  • Oncology: Solid Tumor, Small Cell Lung Carcinoma, Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Acute Myeloid Leukemia, CAR-T, and Colon Cancer, Advanced Pancreatic Adenocarcinomas,
  • Rare Disease: Cystic Fibrosis
  • Cardiovascular Disease: Hypertension and Congestive Heart Failure
  • Immunology: Pediatric Ulcerative Colitis, Psoriasis
  • Infectious Disease: COVID-19, Influenza, and Pediatric Meningitis
  • Ophthalmology: Glaucoma, Cataracts, and Contact Lenses
  • Endocrinology: Type II Diabetes
  • Musculoskeletal: Osteoarthritis

System Experience

  • EDC: iMediata Rave, Mednet Inform 6.1, Medrio and Datalabs
  • IWRS: Clinilabs, Suvido, Signant health and Endpoint
  • eTMF: Veeva Vault, Trial interactive
  • CTMS: VeevaVault, iMediata and Impact
  • Microsoft: Word, Power Point, Excel, Outlook, Sharepoint, and OneNote

Timeline

Clinical Trial Manager

Phanes Therapeutics
04.2024 - Current

Senior Clinical Research Associate

Phanes Therapeutics
03.2023 - 04.2024

Senior Site Manager

Janssen Pharmaceuticals
12.2021 - 12.2022

Senior Clinical Research Associate

Rho Inc
04.2021 - 12.2021

Clinical Research Associate II

Rho Inc
06.2019 - 04.2021

Clinical Research Associate I

Merck Pharmaceuticals
01.2017 - 06.2019

Clinical Trial Associate

Merck Pharmaceuticals
01.2016 - 01.2017

Clinical Research Coordinator

Baylor Scott and White
01.2015 - 01.2016

Bachelor of Science - Health Promotions, Biology Minor

University of Houston

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MEGAN KALU