Senior Clinical Research Coordinator

Duties & Responsibilities:

• Supports Government directors, PIs, in the planning, programming, and execution of clinical research projects and protocols and associated activities.
• Maintain study records related to participation in accordance with protocols, study schedules, participant observation, and provides follow up documentation to the PI.
• Coordinates multiple, concurrent projects for the PI/director; confers with investigator on experimental design; provides instruction on various research laboratory techniques, and study participant contact procedures.
• Organize research information; manages reporting and data collection.
• Monitors comprehensive research study budgets.
• Research equipment/supply catalogs, and recommend purchase requests for projects/protocols in accordance with the IRB.
• Documents all regulatory research and administrative actions needed for study compliance.
• Prepares/delivers required reports and other research documentation to PI.
• Prepares correspondence, creates and maintains study files, develop study schedules, and presentation graphics to support the research study.
• May require occasional weekend and evening hours.

Minimum Qualification and Experience:

• Required: B.S in Biological Sciences; Masters highly preferred.
• Required: Experience coordinating and managing clinical research studies involving human subjects.
• Required: Experience ensuring compliance with all regulatory requirements in clinical research, including FDA regulations, Good Clinical Practice (GCP) guidelines, institutional policies, and IRB requirements.
• 5-8 years’ minimum experience in clinical research.
• Preferred candidate will hold a current certification, such as Certified Clinical Research Coordinator (CCRC).
• Demonstrated competence in oral and written communication.
• Demonstrated experience managing multiple concurrent clinical projects (5+ years).
• Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor.
• Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, Outlook, Access, Publisher, and SharePoint.
• Intermediate+ experience with Adobe Acrobat and internet applications.
• Experience in use of computerized information systems related to Human Subjects Research required (i.e. eIRB or related software).
• Successful completion and maintenance of Human Subjects training / training in human subjects' research protection, bioethics, and HIPAA.