Clinical Research Coordinator C

Perelman School of Medicine at the University of Pennsylvania

About The Position

The Clinical Research Coordinator C serves as a resource for best practices in managing NIH- and industry-sponsored clinical and device trials in the Neuroradiology Clinical Research Division. The coordinator liaises with investigative teams, nursing units, sponsors, and other research staff, and oversees implementation of new trials. The role identifies challenges and opportunities in new studies, develops plans to address issues, and works with the project manager to ensure study procedures and regulatory submissions are completed on time. The coordinator assists with study coordination, participant recruitment, and supervision of trial execution to support protocol adherence. Responsibilities span study start-up through closeout, including regulatory submissions, documentation, data collection and entry, data-query resolution, medical-record review, study-related scheduling, and imaging data transfer. The coordinator audits trials for compliance, enrollment, data accuracy and completeness, and adverse-event management; prepares for audits and inspections; and leads supervision of trial inspections. The role also interacts with sponsors and participates in study initiation, monitoring, audit, and closeout visits, and provides monthly updates to the research team and the division’s director of clinical research. The position is contingent upon grant funding.

Requirements

Bachelor of Science and 4 to 6 years of experience, or an equivalent combination of education and experience.

Responsibilities

Provide guidance on NIH- and industry-sponsored clinical and device trials.
Liaise with investigative teams, nursing units, sponsors, and other departmental partners.
Oversee implementation of new clinical trials and review new trials to identify challenges and opportunities.
Assist research staff with participant recruitment and study coordination.
Organize and maintain study documentation.
Prepare and process regulatory documents for submission to the IRB and other regulatory committees from study start-up through completion.
Work with the project manager to ensure study procedures and regulatory submissions are completed in a timely manner.
Assist in supervising trial execution and ensure staff adherence to study protocols.
Audit trials for compliance and enrollment, including review of data entry for accuracy and completeness and adverse-event management.
Participate in study start-up through closeout and prepare for trial audits and inspections.
Lead supervision of inspections involving the trials.
Assist with site-selection preparation, database entry, data-query resolution, and medical-record review.
Schedule study-related tests in EPIC/Pennchart, Radiology, and other research systems.
Transfer and collect imaging data for processing and analysis.
Interact with sponsors and prepare for and participate in study initiation, audit, monitoring, and closeout visits.
Provide monthly updates to the research team and the division’s director of clinical research.
Perform other duties and responsibilities as assigned.

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
Flexible spending accounts for eligible health-care and dependent-care expenses.
Tuition assistance for employees, spouses, and dependent children; dependent children may also receive tuition assistance at other institutions.
Basic, matching, and supplemental retirement plans with pre-tax or Roth savings options.
Substantial time away from work.
Long-term care insurance.
Wellness and work-life programs and resources.
Professional and personal development resources.
Access to University libraries, athletic facilities, cultural and recreational activities.
Employee discounts and special services.
Flexible work options and hours.
Forgivable home-ownership loan for eligible employees.
Adoption expense reimbursement for eligible employees.