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Clinical Research Manager
Full/Part Time: Full Time
Department: 811 - Health Policy
Requisition Number: 14-1668974
The Clinical Research Manager Non RN will report directly to the Director of Clinical Trial Operations with whom they will collaborate on the responsibilities of coordinating grant-funded cardiovascular and neurovascular clinical trials. The CRN will ensure that these trials are conducted according to Federal Regulations and ICH guidelines.
The CRN plays an integral role in study protocol development, planning study conduct, writing study protocols and Operations Manuals, designing case report forms and working closely with sponsors, including the NIH/NHLBI, NIH/NINDS, FDA and industry
Will take part in the selection of sites, manage the training of study site personnel including investigators and coordinators, plan and run study meetings, and manage/coordinate the day-to-day operational activities associated with conducting Phase II/III clinical trials
Will assist in recruitment strategies and enrollment tracking, data analyses, and manuscript preparation.
Supervise junior staff.
An estimated 30% of time will be spent traveling.
Will carry a phone/blackberry for 24 hour availability.
Experience and Skills:
Strong interpersonal skills. Must be able to work independently within the scope of a team environment. Attention to detail essential. Must possess the ability to work in a dynamic fast-paced environment. Experience working in an academic environment required. Requires a Bachelor's degree. Degree in Nursing, BSN, and Nurse Practitioner license and/or Masters degree preferred. Clinical experience strongly preferred. Cardiovascular and/or critical care clinical experience ideal.
Mnimum of 2-3 years of relevant work experience in clinical research management, preferably in medical device/pharmacological clinical trials. Previous managerial experience strongly preferred.
Familiarity with web-based databases and proficiency in MS Office software highly desirable. Basic knowledge of statistical analyses required.
No direct contact with patients, but HIPAA Compliance training required.
Participation in Medical Surveillance required.
Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.