CLINICAL RESEARCH COORD A/B
Duties: This position will coordinate research projects in OB/GYN within the Division of Reproductive Endocrinology and Infertility. The primary role of Clinical Research Coordinator is the organization, coordination and implementation of a clinical trial for uterine transplant, as well as other projects as assigned, including Phase I-IV clinical trials. The research coordinator will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and follow-up and regulatory documentation.
-Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reaching out to potential recruitment sites/referring physicians, dropping off/posting recruitment materials, etc)
-Collect and report timely, valid, accurate data-maintain clinical trial databases. Respond to data queries. Maintain subject files and regulatory files per GCP
-Collect and process biospecimens (includes performing venipuncture)
-Prepare protocols, informed consents, data collection forms and advertisements for regulatory approval. Coordinate study start up activities. Participate in budget preparation for trials. Be responsible for tracking site reimbursements and allocating patient stipends.
-Perform required research activities per protocol and in accordance with Good Clinical Practice (working with a transdisciplinary team to carry out the protocol, scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, administering drug treatments and/or procedures and monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities)
-Screen, recruit and retain potential study participants. Obtain informed consent at multiple study sites within the Penn Health System (includes approaching potential subjects in the office, or speaking to them by phone, reviewing their medical records and discussing with investigators, asking pre-screening eligibility questions, etc)
The CRC B will perform the above functions with more limited supervision. In addition, the CRC B will act as a mentor to junior staff and participate in their training, will provide education to clinical staff and physicians regarding REI research projects, and participate in quality assurance reviews of research records. The CRC B will also work with REI senior staff to write study protocols, informed consents, manuals of operation, and data collection forms.
Qualifications: CRC A: A Bachelor's Degree and 1 to 3 years of experience or equivalent combination of education and experience required.
CRC B: A Bachelor's Degree and 2 to 4 years of experience or equivalent combination of education and experience required.
Both: The position requires a highly motivated, articulate individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and also as a part of a team. Strong planning, organizational and prioritizing capabilities along with problem solving skills desired. Previous training in medicine preferred for this position. Must be able to work flexible hours.
Reference Number: 40-26426
Salary Grade: 025/026
Employment Type: Exempt
Org: WM-Ctr for Res on Reprod and Women's Health
Job Family: I-Technical/Professional Research