Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
The Clinical Research Manager will report directly to the Director of Clinical Trial Operations with whom he/she will collaborate on the responsibilities of coordinating grant-funded cardiovascular and neurovascular clinical trials. He/she will ensure that these trials are conducted according to Federal Regulations and ICH guidelines.
- 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.
- Participates 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.
- Assists with recruitment strategies and enrollment tracking, data analyses, and manuscript preparation.
- Supervise junior staff.
- Occasional travel will be required. This candidate will carry a phone/blackberry for 24 hour availability.
- 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.
- Ideal candidate should have a minimum of 2-3 years of relevant work experience in clinical research management, preferably in medical device/pharmacological clinical trials.
- Previous managerial experience strongly preferred.