Under the supervision of the Clinical Operations Manager or the Project Manager, Clinical Research, the Clinical Research Associate’s primary responsibilities will be:
- Manage investigator sites: participating in Phase I to IV and PMOS clinical studies.
- Organize and manage critical documents / clinical trial master file.
- Identify critical issues and bring them to the attention of team members including local management, Project Managers, and members of the Global Project Team.
- Coordinate day-to-day project-related activities of contract monitors, CROs, central labs and other service providers as required.
- Plan and coordinate study supplies (drug, laboratory, etc.).
- Acquire knowledge in and work according to SOPs, GCP, relevant regulatory guidance and local law.
- Routine clinical monitoring of clinical sites for compliance with GCP, the study protocol, reporting of adverse events, accounting for study drug, verification of study CRF data against source documents, and completion and filing of regulatory documents.
- Review trip reports (monitoring visit reports) completed by contract monitors or other team members.
- Assist in preparing study budgets and ensures payments.
- Ensure management is kept informed of study progress through trip reports and enrollment updates.
- Assist with and track the resolution of queries generated by data management.
- Assist in drafting study protocols and designing CRFs, patient diaries, medication labels or other study materials when required.
- Assist in Site Selection and Site Evaluation when required.
- Initiate and train study sites.
- Assist in the organization and conduct of investigator meetings.
- Close-out of study sites.
- Assist with audits and audit reports.
To apply for this job please visit www.brunel.net.