Sr. Clinical Research Coordinator
Jefferson Health · Philadelphia, PA · 6 days ago
Information TechnologyFull-time
This position supports observational and interventional research across multiple Neurology divisions, including industry-sponsored and investigator-initiated clinical trials of novel treatments. The role is patient-facing and involves subject identification, consenting, data collection and entry, lab sample processing, and maintenance of study documentation in compliance with federal regulations and Good Clinical Practice (GCP) guidelines.
Responsibilities
- Oversee day-to-day clinical trial activities in accordance with GCP guidelines.
- Independently manage or assist with clinical trials from startup through closeout.
- Coordinate protocol-related activities, including patient screening, recruitment, enrollment, and informed consent.
- Conduct feasibility assessments and study planning activities.
- Manage clinical trial data and biological specimens.
- Prepare for sponsor monitoring visits and audits.
- Prepare and maintain regulatory and Institutional Review Board (IRB) documentation.
- Ensure study procedures are conducted in compliance with protocol requirements and applicable regulations.
- Train and supervise research staff on GCP and study-specific procedures.
- Assist with onboarding and training of new team members.
- Develop and revise workflows, training materials, SOPs, and guidance documents.
- Participate in departmental workgroups and process improvement initiatives.
- Prepare and submit materials to the IRB and other regulatory bodies in a timely manner.
- Maintain subject enrollment and tracking logs.
- Track study-related expenses and submit documentation for grant and study payments.
- Perform quality control reviews to ensure data integrity and regulatory compliance.
- Organize and maintain study records and patient documentation.
- Design and manage electronic data capture databases, when applicable.
- Provide clerical and technical support to ensure adherence to research protocols and data quality.
Requirements
- High School Diploma or equivalent with 6 years of clinical research experience, OR
- Bachelor’s degree with 2 years of clinical research experience, OR
- Master’s degree with 1 year of clinical research experience.
Benefits
- Comprehensive medical (including prescription), dental, and vision insurance.
- Supplemental insurance, life and AD&D insurance.
- Short- and long-term disability coverage.
- Flexible spending accounts.
- Retirement plans.
- Tuition assistance and discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service.
- Voluntary benefits, including group rates on insurance and discounts.
Schedule
Workday Day (United States of America)
Located at 901 Walnut Street, Philadelphia, Pennsylvania, United States of America.