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.
Play 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.
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.
Assist in 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. 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.
- Familiarity with web-based databases and proficiency in MS Office software highly desirable. Basic knowledge of statistical analyses required.
- Excellent written and oral communication skills
- Exceptional attention to detail and accuracy
- Experience in managing staff and financial management
- Ability to motivate, develop and coach individuals
- 5 years experience in a hospital/medical environment