Senior Clinical Research Associate (SCRA)
The Senior Clinical Research Associate (SCRA) is responsible for the following:
- Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Reports to ExecuPharm (EP)/Parexel FSP assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
- Works in partnership internally with Global Clinical Trial Operations (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors, Institutional Review Boards, Institutional Ethics Committees and Regulatory Authorities in support of assigned sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with Good Clinical Practice (GCP) / International Council for Harmonization (ICH), Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects' right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager (CRM) and Partner Line Manager (PLM),
- Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and various other systems as appropriate and per timelines.
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.