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- Assist in securing funded clinical research contracts that are feasible and aligned with health system goals.
- Ensure that applicable regulatory requirements are being met during execution of research trials.
- Assist in working with Finance and Legal to contract and budget research trials.
- Oversee CRAs, research pharmacist, research nurse, and other staff within the department.
- Work with investigators in clinical departments to execute contracts effectively.
- Work with research coordinators in clinical departments involved in trials to achieve study goals.
- Work with the research compliance personnel and the IRB for regulatory requirements.
- Identify interpersonal and individual challenges hindering achievement of departmental goals.
- Discuss departmental issues with the director to determine corrective action measures or areas for improvement.
- Work with IT support and EPIC staff to integrate clinical trial workflows into the electronic medical record. Manage charges related to clinical research in the electronic medical record.
- Prepare written SOPs and develop quality assurance plans.
- Prepare for regulatory audits.
- Perform other duties as requested by the Director or the Department or Research Operating Officer
- Regular undergo continuing education activities to enhance job performance.
- Attend relevant conferences and meetings that are instrumental in achieving any health network goals.
- Local and national travel may be requested.
- Performs other incidental and related duties as required and assigned.
- Strong written and oral communication skills with background in medicine or biomedical science
- Experience managing clinical trial finances.
- Proficient in the use of Microsoft Word, PowerPoint, and Excel. Ability to learn new software as part of the position, including data entry systems (Rave, Inform, etc.)
- Expertise in GCP and clinical trial oversight. SOCRA certified or eligible preferred.
- Experience with electronic health records. Reports to the Director of the Department of Clinical Research
Director Clinical Research - New York, United States - The Goodkind Group
Description
Healthcare Facility located in (Queens, NY) is seeking a skilled Clinical Research Administrator to fill the Assistant Director of Research position | This position requires some local travel to other medical facilities within Queens, NY.
Education and Work Experience:
Master's degree or equivalent Required
PhD, MD, or equivalent preferred
At least 5 years' experience working in clinical research.
Managerial experience required within hospital settings.
Duties and Responsibilities:
Additional Responsibilities:
Skills and Knowledge: