Contractor-Clinical Research Coordinator (Rochester, MI)
Why this Role Exists
The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values.
Responsibilities
-Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
-Complete all relevant Profound Research required training, including but not limited to 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 but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up.
-Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
-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.
-Other duties as assigned.
Requirements
-Bachelor’s degree and 2 years relevant experience in the life science industry OR
-Associate’s degree with 4 years relevant experience in the life science industry OR
-High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year
-Clinical Research Coordinator experience
-Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role
-Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, 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 the ability to adapt to changing schedules and assignments
Travel Requirements
Daily commute to site(s)