Director of Regulatory Affairs
July 1, 2021
Clinical Trial Coordinator/Manager
The Clinical Trial Coordinator/Manager is expected to lead the clinical activities for Embody’s portfolio of biologic solutions for soft tissue healing. This includes the responsibility to manage and conduct a program of clinical studies and related clinical activities, to support product registrations, market access, claims and provide regulatory and commercial support. This candidate should have excellent understanding of Good Clinical Practices and well-developed communication and interpersonal skills to build strong relationships with internal and external customers.
Embody is a commercial stage company pioneering the next generation regenerative platform for the repair and healing of tendon and ligament injuries with novel collagen-based bio-fabrication techniques and products for the fast-growing sports medicine market. Founded in 2014 and funded with over $20 million in DARPA & DOD funding, the company is commercializing unique, collagen-based soft tissue repair products for orthopedic applications including foot & ankle, shoulder, and knee tendon and ligament repair.
The Clinical Trial Coordinator/Manager will report to the Director of Regulatory Affairs. This is a full-time, field-based opportunity.
· Lead the execution and management of activities for company sponsored clinical trials for Embody’s orthopedic/sports medicine medical devices.
· Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for clinical trials.
· Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibility.
· Contribute to the development of clinical evidence plans, including short- and long-term strategy, development of methodologically sound clinical study synopsis and clinical study plans and publication strategy, review and provide feedback on relevant literature, review claims, instructions for use, product extensions, new indications.
· Responsible for delivering clinical trial projects and utilizing clinical systems to ensure all trials, within responsibility, are crafted and delivered against agreed project achievements and to expected quality.
· Support the implementation of new clinical systems/processes.
· Collaborate with site personnel, IRBs/ECs, Competent Authorities/Ministry of Health, contractors/vendors, and company personnel.
· Create and maintain IRB submissions, approvals and amendments.
· Lead the training of investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on methodological study procedures.
· Identify and establish professional relationships with KOLs, potential study investigators and professional organizations to support clinical evidence development and maintenance.
· Responsible for development of Investigator Brochures, monitoring plans, trial protocols, identification and oversight of Case Report Forms (CRF) and Clinical Study Reports (CSR) development. Responsible for site monitoring.
· Collaborate closely with and coordinate vendors and/or Contract Research Organizations (CROs), ensuring appropriate approvals are gained and procedures followed.
EDUCATION AND EXPERIENCE
· B.S. degree in scientific concentration or related field with a minimum of 8-10 years experience in medical device industry, clinical study methodology setting, or scientific/research field required.
· Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
· Ability to handle complex projects, and demonstrates flexibility in managing changing priorities, strategic problem solving and judgement skills.
· Advanced project management skills adequate to lead the entire process of a clinical trial. The individual requires knowledge of clinical study processes and an understanding of study execution.
· Advanced knowledge of industry standards and best practices in clinical data management, US Code of Federal Regulations, ISO 14155, ICH GCP.
· Travel Requirements: 10-20%
Job Type: Full-time
- 401(k) matching
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- 8 hour shift
- Monday to Friday
- Bachelor’s (Preferred)
- medical device, clinical study, or scientific/research field: 8 years (Preferred)
- Fully Remote