Clinical Research Coordinator C
About The Position
This position will be a resource for best practices of managing NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action; will work with the project manager to ensure study procedures and regulatory submissions are completed in a timely manner. Will assist in the supervision and execution of research trials with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in study start-up through closeout, and preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. Additional responsibilities include assistance with study coordination for research trials and other research activities to include site selection preparation, organizing and maintaining study documentation, database entry, resolving data queries, review of medical records, scheduling study-related tests in EPIC/Pennchart, Radiology, and other research systems; preparing and processing regulatory documents for submission to the IRB, and all regulatory committees from study start-up to completion. Interact with study sponsors, preparing and participating in study initiation visits, study audits, monitoring, and closeout visits. Perform other duties as assigned.
Requirements
- Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
Responsibilities
- Provide guidance to both study trials and device trials.
- Serve as a liaison to departmental interactions such as the investigational team, nursing units, and sponsors.
- Oversee the implementation of new clinical trials.
- Review new trials to identify challenges and opportunities.
- Problem-solve challenges to implement a plan of action.
- Work with the project manager to ensure study procedures and regulatory submissions are completed in a timely manner.
- Assist in the supervision and execution of research trials with staff to ensure adherence to protocol.
- Audit trials for compliance and enrollment, including data entry accuracy and completeness, and adverse event management.
- Take an active role in study start-up through closeout, and preparation of trial audits and inspections.
- Take a lead role in supervising any trial inspections.
- Assist with study coordination for research trials and other research activities.
- Perform site selection preparation.
- Organize and maintain study documentation.
- Perform database entry.
- Resolve data queries.
- Review medical records.
- Schedule study-related tests in EPIC/Pennchart, Radiology, and other research systems.
- Prepare and process regulatory documents for submission to the IRB and all regulatory committees from study start-up to completion.
- Interact with study sponsors, preparing and participating in study initiation visits, study audits, monitoring, and closeout visits.
- Provide monthly updates to the research team and the director of clinical research in the division.
- Perform other duties as assigned.
Benefits
- Excellent healthcare and tuition benefits for employees and their families
- Generous retirement benefits
- A wide variety of professional development opportunities
- Supportive work and family benefits
- A wealth of health and wellness programs and resources
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance for employees, spouses, and dependent children at Penn and potentially other institutions
- Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth options through TIAA and Vanguard
- Substantial time away from work for relaxation, vacations, personal affairs, illness, injury, or family time
- Long-Term Care Insurance through partnership with Genworth Financial
- Wellness and Work-life Resources
- Professional and Personal Development resources
- Access to a wide range of University resources, cultural, and recreational activities
- Discounts and Special Services (arts, entertainment, transportation, mortgages, new cars, cellular phone service, movie tickets, theme parks)
- Flexible Work Hours
- Penn Home Ownership Services (forgivable loan for eligible employees)
- Adoption Assistance for qualified expenses related to legal adoption
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
