Sr. Clinical Research Coordinator (Detroit, MI)
Role: Senior Clinical Research Coordinator
Company: Profound Research
Locations: Detroit Metro
Profound Research: Profound Research, a Rubicon Founders portfolio company, seeks to drive clinical innovation through clinical research. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to build an energetic team inspired by changing how patients and providers engage in clinical research.
Role & Responsibilities:
- Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
- Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
- 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 the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
- Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met.
- 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.
- Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
- Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.
- Other duties as assigned.
Requirements & Skills:
- BS/BA in Life Sciences or related discipline and 4 years as a Clinical Research Coordinator OR
- Associate degree and 6+ years as a Clinical Research Coordinator OR
- High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator
- Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
- Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens.
- Excellent attention to detail, organization, and communication with varied stakeholders.
Required Physical Abilities:
- Sit or stand for long periods of time.
- Travel locally and nationally if needed
- Communicate in person and by a telephone
- Limited walking required.
- Limited to lifting up to 30 pounds.