With over seven years of experience in clinical research, I have built a solid foundation across diverse roles, including five years in data management and three years in clinical operations. My career began in data management, where I developed strong analytical and organizational skills, ensuring high-quality data collection, and compliance with regulatory standards. Driven by curiosity and a passion for professional growth, I transitioned into Clinical Operations, joining the CRA Academy with ICON pharma.
I gained a hands-on experience as an In-house CRA, where I supported field CRAs by tracking site performance, managing investigator communications, and ensuring protocol compliance. My role emphasized collaboration, problem-solving, and attention to detail, which directly contributed to the success of site monitoring. These attributes of technical expertise, operational insights, and a commitment to excellence positions me as a valuable asset in the field of clinical research.
· Support the submission of regulatory packages and IRB/IEC submissions.
· Ensure proper documentation in line with regulatory standards, Good Clinical Practice (GCP), and sponsor requirements.
· Collaborate in the preparation for site initiation visits (SIVs), including document collection, organize study files, including the trial master files (TMF), and essential study documentation.
· Serve as a point of contact for clinical sites to answer questions, provide guidance, and resolve issues.
· Support site initiation, monitoring, and closeout activities remotely. Coordinate with sites for timely completion of study milestones, and track site performance.
· Conduct remote monitoring of clinical sites to assess protocol compliance, patient safety, and data quality.
· Identify and escalate protocol deviations, data discrepancies, or compliance issues to the appropriate team members.
· Perform regular data reviews to identify inconsistencies or missing information.
· Generate, track, and resolve data queries with clinical sites and the data management team.
· Assist in the planning and coordination of clinical trial activities, timelines, and deliverables.
· Collaborate with cross-functional teams, including regulatory, data management, and clinical operations.
· Coordinate investigational product (IP) and study supply shipments, ensuring that sites have the necessary materials.
· Prepare and distribute study-related reports, including site performance and status updates.
· Document interactions with clinical sites, maintain correspondence logs, and ensure follow-up actions are completed.
· Assist in training site staff on study protocols, processes, and compliance requirements.
· Support new CRAs and site personnel with procedural guidance and study-specific information.
The CRA academy was a program that was scheduled for 4 weeks which equipped us with knowledge, skills and some role-playing scenarios to prepare us for monitoring responsibilities. The academy provided valuable insights into clinical operations, complementing the experience I already gained, particularly in the field of data management. The program included:
1. Introduction to Clinical Research
History and phases of clinical trials. Drug development process. Roles and responsibilities of a CRA.
2. Regulatory Frameworks
Good Clinical Practice (GCP). International Council for Harmonisation (ICH) guidelines. FDA, EMA, and other global regulatory requirements.
3. Study Protocol design
Understanding Protocols and amendments. Informed Consent Process. Key clinical trial documents (e.g Investigator brochure, case report forms).
4. Site Management and Monitoring
Site selection and initiation. Conducting remote monitoring. Risk-based Monitoring principles.
5. Data Management and Quality Assurance
Handling source documents and verification (SDV). query generation and resolution.
6. Compliance and Ethics
Handling protocol deviations. Ensuring participant safety and data integrity.
7. Practical Training - Simulating site initiation, interim and close-out visits. Review mock patient records for source data verification. Document findings in monitoring visit reports
8. Role -Play Scenarios - Navigating challenging situations with site staff. Escalating compliance issues appropriately.