Basic Qualifications & Interests
- Bachelor’s Degree in nursing or healthcare field and at least 3 years of experience in clinical research, conducting and coordinating all aspects of clinical research studies/trials.
- Required licensure as a RN as granted by the appropriate licensing authority.
- Experience applying knowledge of the following monitoring tasks: regulatory document review, source data verification, (e) 42 CRF review, drug accountability and study supply inventory, and documenting the above activities including any identified issues and action items for resolution.
- Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.
- Experience identifying potential investigators and perform feasibility to assess compatibility for trials.
- Experience in identifying operational issues and recommending and implementing strategies to resolve problems.
- Experience in diagnosing, isolating, and resolving complex issues and recommending and implementing strategies to resolve problems.
- Willing to work a flexible work schedule when needed to ensure coverage of study responsibilities.
- Willing to travel up to 50% of the time for business purposes (within state and out of state).
Preferred Qualifications & Interests
- Master’s Degree / MBA or a Master’s Degree in Public Health, Science (or related field).
- National Institute of Health Human Subjects Protection Certification; CCRP or CCRC certification.
- At least 3 years of experience planning, developing, and managing departmental expense and capital budgets, negotiating research protocols with research/pharma companies.
- At least 2 years of experience in indirect management of team members, including assisting in the development, training and assignment of work/projects to other team members.