Sr. Clinical Research Coordinator- Endocrinology & Metabolism
About The Position
The Sr. Clinical Research Coordinator oversees day-to-day clinical trial activities in accordance with Good Clinical Research Practice (GCP), working independently or with minimal supervision. The role supports portions of clinical trials from startup through closeout, including protocol coordination, feasibility planning, data and biological specimen management, monitoring visit preparation, and regulatory and Institutional Review Board (IRB) documentation. The coordinator ensures study procedures follow the protocol and applicable regulations and may orient and train new staff. The role also assists with workflow development and training documents, revises SOPs and guidance documents, and participates in work groups. The position trains and supervises research staff, prepares and submits materials to the IRB and other regulatory bodies, maintains subject logs and expense records, and submits monthly documentation to the Grant Administrator for payment due for study visits. It performs regular quality control assessments, organizes and maintains patient data, and may design electronic data-capture databases and manage collected data. Clerical and technical support may also be provided to help ensure protocol adherence and quality of research information.
Requirements
- Minimum high school diploma or equivalent.
- One of the following experience and qualification combinations: high school diploma or equivalent plus SoCRA certification and 6 years of clinical research experience; bachelor's degree and 2 years of clinical research experience; or master's degree and 1 year of clinical research experience.
Responsibilities
- Oversee day-to-day clinical trial activities in accordance with GCP.
- Run portions of clinical trials from startup to closeout, including screening, recruiting, enrolling, and consenting participants; feasibility planning; data and biological specimen management; monitoring visit preparation; and regulatory documentation.
- Ensure study procedures are conducted according to the protocol and applicable regulations.
- Train and supervise research staff on proper clinical trial procedures under GCP.
- Prepare and submit materials required by the IRB and other regulatory bodies in a timely manner.
- Maintain accurate subject logs, track expenses, and submit monthly study-visit payment documentation to the Grant Administrator.
- Perform regular quality control assessments to ensure clinical trial data is collected and stored according to GCP.
- Organize and maintain patient data documentation.
- Design electronic data-capture databases when appropriate and manage collected data.
- Assist with staff orientation and training, workflow development, training documents, and SOP or guidance document revisions.
- Provide clerical and technical support as needed to support protocol adherence and research information quality.
- Participate in work groups.
Benefits
- Medical and prescription insurance
- Supplemental insurance
- Dental insurance
- Vision insurance
- Life and AD&D insurance
- Short- and long-term disability insurance
- Flexible spending accounts
- Retirement plans
- Tuition assistance
- Voluntary benefits, including access to group insurance rates and discounts
- Tuition discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service
- Medical and prescription insurance access for all colleagues, including per-diem colleagues and those working less than part-time
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
