Position Type : Full Time
This research coordinator will support the research integrated with the clinical program at PEACE. Our mission is to provide access to compassionate care for women and families seeking family planning care and management of early pregnancy complications. At PEACE, we provide the full spectrum of reproductive health care for planning and preventing pregnancy, treatment of early pregnancy complications and pregnancy loss, and provide options and care for unplanned pregnancies or medically complicated pregnancies. We believe that healthy reproduction is the foundation of a healthy society. Our medical director is Dr. Courtney Schreiber, MD, MPH, whose overarching career goal is to support the reproductive health and lives of underserved women. Research projects include industry sponsored trials (mainly of contraceptives), as well as investigator-initiated projects focusing on miscarriage and family planning. We are seeking a clinical research coordinator with an interest in women’s health and family planning to support this work in our growing program. The primary role of Clinical Research Coordinator is the organization, coordination and implementation of a research study. 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 (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)
—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.
—Other duties and responsibilities as assigned.
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 PEACE research projects, and participate in quality assurance reviews of research records. The CRC B will also work with the PEACE project manager to write study protocols, informed consents, manuals of operation, and data collection forms.
Position is contingent on continued funding.