Assistant Dir of Clinical Research

Assistant Dir of Clinical Research needed to work in Queens, NY. This position requires the employee to perform all aspects of multicenter clinical trial coordination, including working with the Institutional Review Board and the industry sponsors to assure compliance with federal guidelines and policies for conduct of clinical trials. The ideal candidate will have 5 years of clinical research experience, managerial experience, proficient in EPIC and a Masters Degree.

Duties and Responsibilities:

•        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

Additional Responsibilities:

•        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.

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.

Skills and Knowledge:

•        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