Clinical Research Coordinator Sr. (Remote) at Jefferson Health in Philadelphia, PA

Job description

Number of Positions In Requisition 1

 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. Job Description Job Summary The Sidney Kimmel Comprehensive Cancer Center (SKCCC) is seeking a Clinical Research Regulatory Coordinator dedicated to sponsor and investigator-initiated trials. The position reports to a Regulatory Manager within the Research Support Service team of the Clinical Trials Office and provides regulatory support for oncology clinical research studies. The Regulatory Coordinator is responsible for the accurate compilation and submission of protocols and related study documents to the Protocol Review and Monitoring Committee (PRMC) and applicable Institutional Review Board (IRB), and for maintaining regulatory study files to ensure all protocols and essential regulatory documents are current and complete. Primary Responsibilities Serves as the primary regulatory contact for assigned protocols. Maintains the regulatory binders/files and ensures appropriate version control is in place. Coordinates submissions to ancillary committees such as Radiation Safety. Communicates with the IRB and Sponsor on behalf of the study team regarding regulatory management. Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations. Prepares and submits study amendments and continuing review applications for PRMC and IRB review. Prepares regulatory files for auditing and monitoring visits. Minimum Qualifications High School Diploma/GED 5 years High School Diploma/ GED and SoCRA 6 years of clinical research experience or 2 years with Bachelor’s degree and 2 years of clinical research experience or 1 year with Master’s Degree and 1 year clinical research experience. Physical Demands Lift and carry 40-50 lbs. Examples: Push/pull patients on bed, stretcher (requires 29 lbs. push force), lateral transfers up to 50 lbs. of the patient's weight. Frequent to continuous standing/walking. Patient transporters can walk 8-10 miles per shift. *Patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR. Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require. Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson University Primary Location Address 1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/progra