Senior Clinical Research Associate
Resume:
Professional Summary
Accomplished Senior Clinical Research Associate with a track record of managing clinical studies across diverse therapeutic areas. Proficient in study management, data collection, protocol design, and report preparation. Skilled in team leadership, investigator collaboration, and adherence to GCP and ICH guidelines. Committed to excellence and ethical conduct in clinical research. Skills
Protocol Adherence
Data Collection and Analysis
Tracker Development
GCP (Good Clinical Practice)
Vendor Management
Clinical Trial Phases (I -IV)
Patient Recruitment
Site Management
Regulatory Compliance
Risk Mitigation
Documentation and Reporting
Team Collaboration
Problem Solving
Time Management
Therapeutics Areas
Cardiovascular - Diabetes-Related Cardiovascular Disease (Phase IV), Hypertension (High Blood Pressure) (Phase IIb)
Oncology - Non-Small Cell Lung Cancer (Phase III), Breast Cancer (Phase III)
Neurology - Multiple Sclerosis (Phase I), Parkinson's Disease (Phase II)
Gastroenterology - Inflammatory Bowel Disease (Registry)
Dermatology - Psoriasis (Phase IV), Acne (Phase IIa)
Medical Devices - Artificial Heart (Phase III), Advanced Prosthetic Limbs (Phase II), Remote Health Monitoring Device (Phase IV)
Experience
Parexel
Senior Clinical Research Associate Feb 2016 – Present
Performed Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits
(IMV), and Close Out Visits (COV) as per the Clinical Monitoring Plan.
Ensured data accuracy by conducting SDR, SDV, and CRF reviews, both on-site and remotely.
Assessed investigational product through physical inventory and records examination.
Documented observations promptly, adhering to approved business writing standards. Expedited the escalation of deficiencies and issues to clinical management and ensured their resolution.
Maintained regular contact with investigative sites between visits, confirming protocol adherence, issue resolution, and timely data recording.
Executed monitoring tasks according to the approved monitoring plan, including participation in IDORENYIN NOAH
+1-404-***-**** ad2cfc@r.postjobfree.com Atlanta, GA Page 2 of 3
the investigator payment process and collaborative issue resolution.
Reported trends observed across multiple sites to the Clinical Team Manager (CTM) and discussed potential management strategies.
Demonstrated effective verbal, written, and presentation skills to communicate task accomplishments.
Verified completeness and placement of essential documents, following ICH-GCP and applicable regulations. Conducted on-site file reviews as specified by project requirements.
Provided trial status tracking and progress updates to the CTM. Maintained study systems and performed QC checks of CTMS-generated reports when necessary.
Fostered communication between investigative sites, the client company, and the PPD project team through written, oral, and electronic channels.
Responded to company, client, and regulatory requirements, audits, and inspections in compliance with federal regulations.
Timely completion of administrative tasks, including expense reports and timesheets. Syneos Health
Clinical Research Associate II May 2014 – Feb 2016
• Supported protocol development and design for new studies.
• Recruited diverse and representative study populations through effective strategies.
• Improved data quality and reduced data discrepancies through site visits.
• Resolved study-related issues with cross-functional teams, ensuring successful execution of trials.
• Prepared and submitted regulatory documents to ethics committees and authorities.
• Handled study material shipment and receipt by sites.
• Prepared and submitted regulatory and ethical documents for completeness.
• Managed essential study documentation, such as informed consent forms and case report forms.
• Audited internally and complied with SOPs and regulatory guidelines.
• Communicated regularly with sites and supported site activation.
• Verified source documents for compliance, data accuracy, and patient safety.
• Reviewed safety information and informed consent of study subjects.
• Ensured source data and study database were accurate, complete, and properly maintained.
• Resolved data queries and reviewed CRFs using paper or electronic systems.
• Wrote site visit reports and documented findings. Methodist Hospital
Lead Clinical Research Coordinator Apr 2012 – Apr 2014
Efficiently screened and recruited eligible participants for clinical trials, surpassing enrollment targets.
Maintained precise and timely data entry and study record management, enhancing data quality and reducing cleaning efforts.
Fostered excellent communication with study sponsors, investigators, and stakeholders, ensuring a high satisfaction rate.
Played a vital role in refining research processes and protocols, boosting operational efficiency.
Achieved a high informed consent rate from study participants, minimizing dropout rates and promoting voluntary participation.
Collaborated closely with study sponsors, investigators, and stakeholders to ensure successful study execution.
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Implemented participant engagement strategies, improving retention rates and study adherence.
Assisted in monitoring and auditing activities, ensuring compliance with regulatory guidelines.
Contributed to the development of comprehensive study reports and supported junior team members in their professional growth.
Education
University of Calabar: BSC – Soil Science Nov 2011
University of Calabar: Diploma – Agricultural Science Nov 2005 Certifications
Certification in Leadership and Management Apr 2012
Certified Healthcare Leadership (CHL) July 2016
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