CLINICAL RESEARCH COORD B
Duties: The primary role of Clinical Research Coordinator B is the organization, coordination and implementation of research studies within the Penn PCOS Center. The essential functions of the position include but are not limited to:
Assist investigators in writing protocols, informed consents, manuals of operation, and data collection forms. Prepare and submit study documents for regulatory approval. Coordinate study start up activities. Participate in budget preparation for trials. Be responsible for tracking site reimbursements and allocating patient stipends.
Interface with regulatory authorities and sponsors. Attend Investigator Meetings for clinical research trials. Organize and participate in site visits, both initiation and otherwise. Prepare for and host both internal and external auditing and monitoring activities.
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)
With minimal supervision, 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).
Collect and report timely, valid, accurate data. Maintain clinical trial databases. Respond to data queries. Maintain subject files and regulatory files per GCP
With minimal supervision, perform required research activities per protocol and in accordance with GCP (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)
Collect and process biospecimens (includes performing venipuncture)
Act as a mentor to junior staff and participate in their training.
Assist the PI with administrative needs of the research program in the Penn PCOS Center.
Position is contingent on continued funding.
Qualifications: Bachelor's degree and 2-4 years of experience, or equivalent combination of education and experience, are required. Position requires an articulate individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and also as part of a team. Strong planning, organizational and prioritizing capabilities along with problem solving skills desired.
Position requires a experience in IRB processes and regulatory management.
Must be able to work flexible hours.
Reference Number: 40-25967
Salary Grade: 026
Employment Type: Exempt
Org: WM-Ctr for Res on Reprod and Women's Health
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research