What are the responsibilities and job description for the Clinical Research Coordinator Senior - Study Start Up Specialist position at Thomas Jefferson University & Jefferson Health?
Job Details
Jefferson Clinical Research Institute (JCRI) seeks a highly motivated and detail-oriented Clinical Research Study Start-Up Specialist to join our dynamic team. The ideal candidate will be responsible for managing and overseeing the start-up phase of clinical trials, ensuring that all required regulatory, site, and logistical components are completed in a timely and efficient manner. This role requires strong organizational skills, a deep understanding of clinical trial processes, and the ability to collaborate with cross-functional teams to ensure smooth and successful study initiation. Works with minimal supervision. This role will be the main contact for all trial start-up activities, across multiple departments, including but not limited to preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. Trains research staff, supervises staff and oversees clinical trials from start-up to closeout. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, oversees research operation in a division or department and provides expert consulting at an institutional level.Job Description
Essential Functions:
- Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
Study Start-Up Coordination:
- Lead and coordinate all activities related to the start-up phase of clinical trials, including but not limited to: feasibility, site selection, regulatory submissions, committee approvals, and site training.
- Ensure that all documentation is accurate, complete, and compliant with regulatory requirements, including but not limited to: IRB submissions, informed consent forms, and investigational product documentation.
- Works to identify and problem-solve potential roadblocks to success.
- Oversees and participates in the build of study workflows and timelines.
Regulatory and Compliance:
- Oversee and participates in the preparation and submission of regulatory documents, including but not limited to: approvals, applications, investigator brochures, and other essential regulatory submissions to the necessary authorities and committees.
- Collaborate with internal and external stakeholders (e.g., sponsors, CROs, PIs, IRBs, approval committees) to ensure all approvals are obtained in a timely manner.
Site Management:
- Work closely with site personnel to ensure the timely initiation of clinical study sites, including contracting, budget negotiation, and site feasibility assessments.
- Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP.
- Reviews effort reports of site personnel and analyzes start-up processes for accuracy and efficiency.
- Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP and JCRP standards
- Designs or assists in design of 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:
Minimum High School Diploma or equivalent
AND
Experience:
Bachelor's degree and 5 years of clinical research experience or master's degree and 3-year clinical research experience.
Work Shift
Workday Day (United States of America)Worker Sub Type
RegularPrimary Location Address
833 Chestnut Street, Philadelphia, Pennsylvania, United States of AmericaNationally 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/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200 undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
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.
As an employer, the Jefferson Enterprise maintains a commitment to provide equal access to employment. Jefferson values diversity and encourages applications from women, members of minority groups, LGBTQ individuals, disabled individuals, and veterans.
