"Clinical Research Coordinator B/C"

Job Description Summary

As part of the Infectious Disease Clinical Trials Group, this position will coordinate clinical research consisting of projects in HIV, COVID19, and other Infectious Diseases. The person will support Infectious Disease Investigators in clinical research ranging from observational trials to investigational product trials, including both investigator-initiated and industry-initiated trials. Work requires on-site presence and interaction with research subjects across Penn Campus. Research coordinator work includes study implementation, community outreach, document development, regulatory work, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies across Penn Campus.

Job Responsibilities

Clinical Research Coordinator B (CRC-B): The CRC-B will coordinate clinical trials within the Penn Infectious Disease Clinical Trials Unit, consisting of projects focused on HIV and other Infectious Diseases. The person will support Infectious Disease Physician Investigators in clinical research ranging from observational trials to investigational drug/product trials, including investigator-initiated, government funded, and industry-sponsored trials. This position requires an on-site presence to interact with research subjects across Penn Campus.
Duties include, but are not limited to:
• Participating in site initiation visits, interim monitoring visits, audits, and close-out visits.
• Assisting in the development/maintenance of study specific case report forms and source document tools.
• Developing study specific source documents and trackers
• Preparing and submitting regulatory packages
• Corresponding with sponsor & regulatory review boards
• Assisting with study start up activities
• Screening, recruiting, and consenting patients according to protocol.
• Scheduling patient study visits and any necessary testing.
• Conducting patient study visits according to protocol (depending on study and visit, this could include questionnaires, documenting reported medical history and side effects, collecting vitals, drawing blood, etc.)
• Monitoring and ensuring patients adherence to protocol requirements.
• Collecting study data, completing case report forms, and resolving data entry errors/queries
• Communicating with study team members.
• Organizing and maintaining all documentation required by the Investigator, sponsor or CRO (i.e. source documents, case report forms, and research charts).
• Processing and shipping study specimens including blood and urine.
• Participating in reoccurring study team meetings and ongoing protocol training.
• Showing vigilance in patient safety, protocol compliance, and data integrity.
• Adhering to all University of Pennsylvania, FDA, and GCP guidelines.

Clinical Research Coordinator C (CRC-C): In addition to above, the CRC-C will have limited supervision from the project manager and will need to use more independent judgment when managing their assigned clinical trials.

Qualifications

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; strong attention to detail; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations; high reliable and good work ethic required. Position contingent on funding.

Clinical Research Coordinator B: Bachelor's degree required and 2-3 years of related experience (or equivalent combination of education and experience). Phlebotomy and regulatory experience preferred.

Clinical Research Coordinator C: Bachelor's degree required and 4-6 years of related experience (or equivalent combination of education and experience). Phlebotomy and regulatory experience preferred.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $68,000.00 Annual Rate