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Profound Research partners with community physicians to offer clinical trials as a therapeutic option for their patients. The company handles all infrastructure, regulatory compliance, and administrative operations so physicians can focus on patient care.
The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with applicable laws, regulations, and study protocols while maintaining the company's mission of improving lives by providing advanced therapeutic options.
Key Responsibilities:
- Conduct and manage all clinical trial activities in accordance with established research protocols and standards, ensuring compliance with applicable laws, regulations, policies, and procedural requirements
- Complete required training including ICH-GCP certification and IATA certification in a timely manner
- Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
- Lead, implement, and coordinate duties for assigned clinical trials including study start-up, vendor management, subject recruitment, source document review, protocol training, regulatory document collection, participant visits, data collection and documentation, adverse event management and reporting, and monitoring visits
- Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
- Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products
- Perform other duties as assigned
The role is performed on-site at a clinical or office facility and requires prolonged periods of sitting, standing, or walking. Daily commute to site(s) is required. The position may require travel between company sites, meetings, or partner locations.
Requirements:
- Bachelor's degree with 2 years relevant experience in life sciences industry, OR Associate's degree with 4 years relevant experience, OR High School diploma/technical degree with minimum 6 years relevant experience AND 1 year Clinical Research Coordinator experience
- Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of hire
- Experience performing clinical assessments including obtaining vital signs, EKGs, blood draws, and processing/shipping lab specimens
- Proficient ability to work independently, plan and prioritize with minimal guidance
- Excellent attention to detail, organization, and communication with varied stakeholders
- Ability to work as a team player with ability to adapt to changing schedules and assignments
- Ability to communicate clearly in verbal and written forms and read/interpret detailed materials
- Ability to navigate clinical facilities and transport supplies or work materials as needed
