Clinical Research Director
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Overview
Clinical Research Director
Responsibilities
EDUCATION:
Clinical Research Director
- Full-Time, 40 hours per week.
- Monday- Friday; Hours will vary.
- Location: Downers Grove
Responsibilities
- Leadership & Management
- Lead and oversee all clinical research activities, including the feasibility, contracting, execution, quality control, and completion of clinical trials
- Provide strategic direction to operational and clinical research teams
- Serve as the primary contact point for third-party site network organizations and contract research organizations (CRO)
- Serve as a liaison between the research department and other clinical and administrative teams within the clinic
- Develop and maintain relationships with external sponsors, CRO, and regulatory bodies
- Regulatory compliance
- Work with third party vendors and trial Sponsors for audits and regulatory inspections
- Ensure timely reporting of adverse events, protocol deviations, and other critical data to necessary authorities
- Maintain knowledge of current federal, state, and international regulatory guidelines and ensure that all clinical research activities comply with these requirements
- Ensure adherence to regulatory, legal, and the highest ethical standards
- Reporting
- Communicate research results to internal and external stakeholders, including clinicians, sponsors, and regulatory agencies
- Lead efforts in creating and summarizing financial and operational outcomes to organizational leadership
EDUCATION:
- Bachelor's degree required. Master's degree highly preferred.
- 5+ years of experience in clinical research required.
- Previous experience working with site network organizations and negotiating contracts required.
- Must have experience with regulatory bodies and knowledge of IRB process.
- Previous experience working with specific EMR and clinical trial management software required.
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