University of Pennsylvania · 2 days ago
Clinical Research Coordinator B/C
Philadelphia, PA
Full-time
Onsite
Mid, Senior Level
$52K/yr - $67K/yr
2+ years expThe University of Pennsylvania is a world-renowned leader in education, research, and innovation. They are seeking a Clinical Research Coordinator to support the operations of clinical trials focused on dermatologic diseases, ensuring high-quality clinical research in accordance with regulatory requirements.
Continuing EducationEdTechEducationSTEM EducationUniversities
Responsibilities
Screen, recruit, consent, and enroll study participants as specified per protocol and GCP guidelines
Schedule, prepare for, and conduct protocol-required participant visits and assessments
Review clinic schedules and medical records to identify potentially eligible participants and support recruitment efforts
Prepare and submit IRB documentation for initial submissions, continuing reviews, amendments, and adverse event reporting
Coordinate, organize, complete, and maintain source documents, case report forms, regulatory documents, and participant binders in accordance with ALCOA-C standards
Enter data into electronic data capture systems (e.g., REDCap, sponsor systems) and ensure data accuracy and completeness
Perform data quality control and resolve data queries within required timelines
Monitor participants per protocol requirements and document adverse events and protocol deviations as applicable
Demonstrate vigilance in participant safety, protocol compliance, and data quality
Adhere to all University of Pennsylvania policies and applicable FDA and GCP guidelines
Effectively manage multiple clinical trials independently while supporting other coordinators as needed
Demonstrate problem-solving skills by identifying challenges and escalating issues appropriately
Develop, present, and implement participant recruitment strategies in collaboration with investigators and the research team
Work closely with the Clinical Research Program Manager to support study start-up, activation, and ongoing trial operations
Lead participant screening by reviewing medical records and assessing eligibility criteria
Conduct informed consent discussions, ensure participant understanding, and maintain required documentation. Support recruitment through clinic schedule review, coordination with investigators and referring providers, and direct outreach to potential participants
Coordinate all protocol-required visits, treatments, assessments, and follow-up appointments to ensure adherence to study timelines and procedures. Meet with the Principal Investigator to review participant status, required next steps, and address questions related to assessments, documentation, or clinical issues. Identify operational barriers and escalate items requiring medical or regulatory decision-making
Monitor participants per protocol requirements, document adverse events and concomitant medications, and complete safety reporting in a timely and accurate manner. Report adverse events to the sponsor, IRB, and designated oversight groups in accordance with study and institutional requirements
Prepare study start-up materials, including visit guides, source documentation tools, participant binders, e-regulatory binders, and required tracking logs. Assemble and submit documents to institutional committees (e.g., IRB, CTSRMC) to support study activation. Confirm workflow feasibility with clinic operations and ensure readiness prior to first enrollment
Review clinical information from visits and assessments and enter required data into electronic data capture platforms with a focus on accuracy and completeness. Maintain organized source documentation, regulatory files, and enrollment logs to support monitoring, audit, and internal review. Ensure data entry, document updates, and data queries are addressed within study timelines
Participate in study meetings, initiation sessions, and protocol training. Provide regular updates on enrollment progress, visit completion, safety reporting, and data status. Support operational consistency by identifying workflow needs and contributing to tools, guidance documents, or process improvements that enhance study execution
Perform additional duties as assigned
Qualification
Required
Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required for Clinical Research Coordinator B
Bachelor's degree and 4-5 years of experience, or equivalent combination of education and experience, are required for Clinical Research Coordinator C
Practical experience coordinating the day-to-day activities of multiple research projects for Clinical Research Coordinator B
Practical experience coordinating the day-to-day activities of multiple therapeutic research protocols for Clinical Research Coordinator C
Effective verbal and written communication skills
Ability to learn new methods quickly and multi-task
Demonstrated ability to work as part of a team as well as independently
Possess working knowledge of International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines
Effective problem-solving abilities
Strong organizational and time management skills
Flexible and able to multi-task
Knowledge of IRB and human research protection regulations
Benefits
Health, Life, and Flexible Spending Accounts
Tuition
Retirement
Time Away from Work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development
University Resources
Discounts and Special Services
Flexible Work Hours
Penn Home Ownership Services
Adoption Assistance
Company
University of Pennsylvania
The University of Pennsylvania is an American private Ivy League Research University that excels in producing future leaders.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$81.46MKey Investors
National Science FoundationUS Department of EnergyParent Project Muscular Dystrophy
2024-08-28Grant
2023-06-26Grant· $18M
2022-09-15Grant· $55M
Leadership Team
Mark Dingfield
Executive Vice President
Angela Duckworth
Rosa Lee and Egbert Chang Professor
Recent News
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