Clinical Trial Manager
craresources
Job Responsibilities:
- Participate in site identification, recruitment, and selection.
- Manage regulatory document collection and review.
- Overall scheduling and management of all site visits.
- Develop site/monitoring tools and training materials.
- Ensure CRAs assigned receive therapeutic and project-specific training.
- Define and implement functional standards, goals, and expectations with the clinical monitoring team.
- Serve as CRA mentor and perform accompanied field assessment visits as required.
- Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
- Review and identify trends in enrollment and data entry at sites and proactively interface with the clinical monitoring team to identify solutions.
- Set and enforce project timelines with the assigned study team.
- Coordinate remote review of clinical data within the EDC system.
- Assure that appropriate SOPs are followed.
- Oversee monitoring visit schedule to ensure compliance with the frequency set forth in the monitoring plan.
- Review and approve trip reports and follow-up letters within the required time-frame.
- Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
- Ensure all project documentation is appropriately filed per SOPs.
- Schedule and manage weekly CRA project team meetings.
- Review and approve CRA travel expenses and timesheets.
- Attend and provide information at monthly projections meetings.
- Attend and provide information at weekly teleconferences/team meetings.
- Assist PM in preparation of audit responses, as appropriate.
- Assist PM in the review of project budgets, monitoring costs, potential overruns, and propose/implement cost-effective solutions.
Job Qualifications:
- Minimum 4 years of experience as a fully dedicated regional, home-based, field monitor for a CRO or Pharma
- Minimum 2-3 years of Clinical Trial Management experience
- Experience in managing the coordination and daily operations of a clinical monitoring team
- Experience working in Oncology studies is a plus