Harrison Martey
AstraZeneca Pharmaceuticals
Dallas,Texas
12
years of professional experience
Clinical Research professional with 10+ years of experience in the U.S. clinical trial operations, including study start-up, site management, monitoring oversight, regulatory compliance, and cross-functional leadership. Demonstrated success in managing complex Phases I to IV clinical trials across multiple therapeutic areas while ensuring quality, patient safety, and on-time delivery.
Work History
Sr Clinical Research Associate
2 Years- Contributes to study start-up and regulatory maintenance tasks including SQVs and SIVs, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study, site activation and enrollment drives.
- Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
- Ensure, monitor and manage site staff trainings including ICH-GCP, study protocol and other training from SSU and throughout the entire duration of the study, to ensure sites maintain inspection-readiness.
- Reviewing and providing feedback SQV, SIV, IMV and COV reports.
- Contributed to National Investigators meetings.
- Initiates, monitors and closes study sites in compliance with company SOPs, reviews and resolves study quality issues within the LST.
- Updates CTMS and other systems with data from study sites as per the required timelines.
- Manages study supplies (ISF, etc), drug supplies and drug accountability at study sites. Prepares study drug for destruction, as applicable.
- Conducted monitoring visits (remote and onsite) and performed remote data checks per study-specific Monitoring Plan timelines, collaborating with trial managers/directors to determine optimal timing and type of visits as needed.
- Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
- Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. Ensures data query resolution in a timely manner.
- Works with data management to ensure robust quality of the collected study data. Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
- Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with company SOP.
- Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
- Escalated systematic or serious quality issues, data privacy breaches, and CSP or ICH-GCP compliance issues to Local Management and/or CQM, ensuring adherence to quality issue processes.
- Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with trial managers/directors and Quality Directors.
- Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, company SOPs and local requirements. Supports/participate in regular QC checks performed by Trial Managers/Directors or delegate.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Collaborated with local MSLs to exchange relevant study information and insights. as directed by Trial Managers/Directors or line manager.
Site Manager
1 Year 9 Months- Drove activities within site initiation and start-up, preparation, and conduct of site monitoring and site management according to SOPs, Work Instructions, and policies.
- Ensures site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
- Aligned with relevant training requirements, and acts as a local expert in assigned protocols. Develops therapeutic knowledge sufficient to support roles and responsibilities.
- Collaborated closely with LTM and the central study team during the site activation phase to expedite the process and activate the site efficiently.
- Contributed to site-level recruitment strategy, prioritization, and implementation in partnership with other functional areas.
- Ensure that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
- Prepared for inspection readiness and conducted audits.
- Coordinated the safe and compliant disposal of clinical supplies by following established protocols.
- Ensured site staff completes data entry and resolves queries within expected timelines.
- Ensured accuracy, validity, and completeness of data collected at trial sites, supporting regulatory compliance and data integrity.
- Ensured that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- Maintains complete, accurate, and timely data and essential documents in relevant systems used for trial management (EDC, CTMS, eTMF, etc.).
- Writes visit reports and follow-up letters following the SOPs.
- Served as the primary local company contact for assigned sites during specific trials.
- Attended investigator meetings as necessary.
- Collaborated with LTM to complete Corrective Action Preventative Action (CAPA) for Quality Assurance site audits and address quality issues identified during routine monitoring.
- Established and maintained good working relationships with internal and external stakeholders in particular investigators, trial coordinators, and other site staff.
Senior Clinical Research Associate
2 Years 9 Months- Provided site management and monitoring support for sponsored clinical studies.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of sites.
- Conducted Source data review/verification according to the monitoring plan.
- Ensured adherence to ICH-GCP guidelines, Investigator's integrity, and compliance with all study procedures through on-site monitoring visits.
- Monitored all aspects of study sites, including routine monitoring and close-out activities.
- Trained site staff and communicated directly with investigative sites to provide study direction, answer questions, assess recruitment rates, and respond to sponsor requests.
- Performed and led the review of clinical data listings for completeness and accuracy and escalated issues.
- Guided junior clinical research associates in their tasks and responsibilities.
- Organized and managed internal team meetings, investigator meetings, and other trial-specific meetings.
- Trained site staff and communicated with investigative sites to provide study direction, address inquiries, assess recruitment rates, and respond to sponsor requests.
- Mentored junior clinical research associates.
- Assisted with writing, revising, and participating in training and presentations of industry Standard Operating Procedures.
- Interpreted data to identify protocol deviations and risks to subject safety and data integrity.
Clinical Research Associate II
2 Years 7 Months- Managed Trial Master File (TMF) and Investigator site files throughout study duration, ensuring accurate and timely filing of essential documents to support study integrity.
- Conducted on-site and remote study monitoring visits and site management.
- Ensured that monitoring activities (remote and on-site) were completed following the company’s SOPs and clinical monitoring plan.
- Supported regulatory submission processes by preparing and organizing necessary documents. to the Institutional Review Board (IRB).
- Collected, reviewed, and processed regulatory documents and correspondence from participating trial sites as well as assisted in the file reconciliation process in preparation for audits and archival.
- Addressed various site issues by collaborating with site staff to identify solutions., including site recruitment challenges, and determined the status of the Investigational Product (IP) shipment.
- Provided clinical support for Data Management by resolving data queries and clarifying data entries.
- Ensured that studies adhered to FDA regulations and Good Clinical Practices.
- Performed Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Produced comprehensive trip reports, confirmation, and follow-up letters in alignment with SOPs and monitoring timelines, facilitating effective communication with stakeholders.
Clinical Research Associate I
1 Year 10 Months- Scheduled and conducted pre-study visits, initiation visits, interim monitoring visits, and closeout visits according to the Monitoring Plan.
- Ensured that all study documents and materials supporting study execution were complete, accurate, maintained, and updated.
- Tracked CRF status to ensure timely completion and adherence to study timelines.
- Tracked CRF status and ensured the timely completion of CRFs.
- Monitored study-related clinical activities for compliance with ICH/GCP guidelines, SOPs, country-specific regulations, and project requirements.
- Generated essential clinical documents, including informed consent forms, site training materials, clinical monitoring plans, and source document templates, to support study execution.
- Verified that the investigator, staff, and site facilities remained adequate throughout the trial period.
- Assisted with SOP development, implementation, and training.
Clinical Research Coordinator
1 Year 7 Months- Supported patient enrollment in clinical trials through recruitment, screening, and follow-up of eligible subjects according to protocol requirements.
- Updated and maintained study enrollment logs and submitted them to the Sponsor.
- Worked in collaboration with the study team and QA Manager to ensure trial preparation and coordination.
- Conducted weekly team review meetings to share insights on clinical research processes and enhance team performance.
- Oversaw clinical operations for trial conduct, managing recruitment, visit coordination, and scheduling.
- Ensured execution of Sponsor expectations and Standard Operating Procedures (SOPs).
- Documented all patient activity in source documents and CRFs according to ICH/GCPs, and Federal regulations.
Education
Bachelor of Science Degree - Chemistry, Forensic Chemistry
Higher National Diploma (HND) - Science Laboratory Technology
Master of Arts Degree - Criminal Justice
Skills
Clinical trial management
Stakeholder collaboration
CTMS experience
Data management proficiency
Coordinating site operations
Informed consent process
Proficient in Microsoft Office Applications.
Project management
Therapeutic Experience
- ONCOLOGY: Liver Cancer, Breast Cancer, Sickle Cell Disease, Solid Tumor. (3yrs, 7months)
- MEDICAL DEVICES/IVD: Heart Valves, Catheters, Ulcerative Colitis, Inhalers (2yrs)
- RESPIRATORY: Asthma, Pulmonary Fibrosis, Influenza (4yrs)
- CARDIOVASCULAR: Hyperlipidemia, Heart Failure, Pulmonary Hypertension (3yrs)
- IMMUNOLOGY: Rheumatoid Arthritis, Osteoarthritis, Psoriasis Arthritis (2yrs)
- INFECTIOUS DISEASES: COVID-19 (Vaccine). (2yrs, 4months)
Timeline
Sr Clinical Research Associate
AstraZeneca Pharmaceuticals
08.2024 - CurrentRead More
Site Manager
Johnson & Johnson
11.2022 - 08.2024Read More
Senior Clinical Research Associate
Premier Research
02.2020 - 11.2022Read More
Clinical Research Associate II
Premier Research
07.2017 - 02.2020Read More
Clinical Research Associate I
PPD
09.2015 - 07.2017Read More
Clinical Research Coordinator
Memorial Sloan Kettering Cancer Center
02.2014 - 09.2015Read More
Arkansas State University
Master of Arts Degree from Criminal Justice
Read More
Accra Technical University
Higher National Diploma (HND) from Science Laboratory Technology
Read More
Arkansas State University
Bachelor of Science Degree from Chemistry, Forensic Chemistry
Read More