About the job
The Clinical Research Coordinator II plays a pivotal role in the execution of clinical research, taking charge of increasingly complex projects. This position requires an individual who can independently oversee essential components of extensive studies or manage all facets of smaller research initiatives.
Key Responsibilities
- Direct subject recruitment and achieve study enrollment targets by crafting effective strategies to attract and retain participants for long-term clinical trials.
- Oversee data management for research projects, including developing systems for data organization, collection, reporting, monitoring, and analysis.
- Establish project schedules, targets, and accountability measures, leading team meetings and ensuring accurate minutes are documented.
- Guide, train, and mentor new employees or interns, assisting in hiring processes, performance evaluations, and project instruction.
- Conduct audits on operational processes, including laboratory procedures, to ensure adherence to regulatory standards while identifying and enacting corrective measures.
- Manage submissions to the Institutional Review Board, addressing inquiries and collaborating with principal investigators and study sponsors.
- Lead initiatives to assess and implement enhancements to policies and procedures, establishing best practices.
- Collaborate with staff and principal investigators to create study budgets, clarify standard care versus study procedures, track milestones, and invoice sponsors per study contracts.
- Ensure ongoing regulatory compliance through regular inspections of study documentation.
- Work closely with principal investigators to facilitate Investigational New Drug applications to the FDA when necessary and complete Institutional Review Board renewals.