Job Title: Assistant Director - Clinical Research
Reports to: Director of the Department of Clinical Research
Location: Queens, NY
Type: Direct-Hire | Full-Time
Compensation: $110,000-$130,000
Summary: This full-time position offers a unique opportunity to provide comprehensive support for multicenter clinical trials. The Assistant Director for Clinical Research will play a pivotal role in ensuring compliance with federal guidelines and policies, collaborating closely with Institutional Review Boards (IRBs) and industry sponsors.
Essential Duties and Responsibilities:
- Assist in securing funded clinical research contracts aligned with health system goals.
- Ensure compliance with regulatory requirements throughout the execution of research trials.
- Collaborate with Finance and Legal departments to contract and budget research trials.
- Supervise Clinical Research Associates (CRAs), research pharmacists, research nurses, and other departmental staff.
- Facilitate effective execution of contracts with investigators in clinical departments.
- Coordinate with research coordinators to achieve study goals.
- Liaise with research compliance personnel and the IRB for regulatory adherence.
- Address interpersonal and individual challenges hindering departmental goals.
- Consult with the director to identify corrective measures and areas for improvement.
- Integrate clinical trial workflows into the electronic medical record system with IT support and EPIC staff.
- Prepare written Standard Operating Procedures (SOPs) and develop quality assurance plans.
- Prepare for and participate in regulatory audits.
- Perform other duties as directed by the Director or the Department of Research Operating Officer.
Other Responsibilities:
- Engage in continuing education activities to enhance job performance.
- Attend relevant conferences and meetings to achieve health network goals.
- May be required to undertake local and national travel as needed.
Education and Work Experience:
- Master's Degree or equivalent required; PhD, MD, or equivalent preferred.
- Minimum of 5 years of experience in clinical research, with managerial experience.
- Strong background in medicine or biomedical science.
- Experience managing clinical trial finances.
- Proficiency in Microsoft Word, PowerPoint, and Excel.
- Familiarity with data entry systems (e.g., Rave, Inform).
- Expertise in Good Clinical Practice (GCP) and clinical trial oversight, SOCRA certification preferred.
- Experience with electronic health records.