Clinical Research Coordinator Senior (HYBRID) - Einstein

Job Details Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Runs portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups. Essential Functions Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson. Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP. Prepares and submits all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely fashion. Maintains accurate subject log, tracks expense, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies. Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP. Organizes and maintains documentation of all patient data. Designs electronic capture databases, if appropriate, and manages all the data collected. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. Minimum Education and Experience Requirements Education: Minimum High School Diploma or equivalent. Experience: High School Diploma or equivalent with SoCRA certification preferred and 6 years of clinical research experience; or bachelor’s degree with 2 years of clinical research experience; or master’s degree with 1-year clinical research experience. Work Shift Workday Day (United States of America) Benefits Jefferson offers a comprehensive package of benefits for full‑time and part‑time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short‑ and long‑term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full‑time service or two years of part‑time service. All colleagues, including those who work less than part‑time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. Equal Employment Opportunity Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. #J-18808-Ljbffr