"Clinical Research Coordinator A/B"

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes 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, and much more.

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. The position will assist the Research Nurse with community outreach efforts throughout Philadelphia to recruit study participants which may involve travel throughout Philadelphia and surrounding areas to community-based venues. 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.

Job Responsibilities

Clinical Research Coordinator A

Participate in and coordinate clinical trials within the Penn Infectious Disease Clinical Trials Unit, 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. Involves outreach work to recruit subjects from Philadelphia region. Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study team members. Recruit, consent and screen patients according to protocol. Schedule patient visits and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocol requirements. Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts. Collect, review and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, and ongoing protocol training. Assist in the development/maintenance of study specific case report forms and source document tools. Show vigilance in patient safety, protocol compliance and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Clinical Research Coordinator B

In addition to above, will develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start up activities. The CRC B will have less supervision in the management of clinical trials and will need to use more independent judgment.

Qualifications

Clinical Research Coordinator A

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

Clinical Research Coordinator B

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Preferred: 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.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $52,661.00 Annual Rate

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.