Overview Clinical Research Director
- Full-Time, 40 hours per week.
- Monday- Friday; Hours will vary.
- Location: Downers Grove
The Clinical Research Director will lead, manage, and oversee the clinical research operations at a multispecialty outpatient medical clinic. This role involves the strategic planning, execution, and management of clinical trials across multiple specialties. The Clinical Research Director will collaborate with internal teams, external partners including Site Network Organizations, and patients to ensure the successful conduct of research studies, with an emphasis on maintaining the highest standards of ethics, compliance, and scientific rigor.
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
Qualifications EDUCATION:
- Bachelor's degree required. Master's degree highly preferred.
EXPERIENCE:
- 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.