Clinical Research Coordinator A/B, Infectious Diseases Department
3 days left
- Full Time
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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
This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors Coordinators and Research Assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials. Adheres to all University and other regulatory guidelines.
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.
Position is contingent upon funding.
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. Coordinator duties include:
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.
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.
1) Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants. Includes community outreach efforts throughout Philadelphia to recruit study participants, which will require travel to community venues.
2) Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
3) Prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
4) Correspond regularly with Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports, and DSMB subject narratives.
5) Coordinator A: With supervision, assist in preparation of source documents and study trackers. Coordinator B: With supervision, assist in preparation of source documents, case report forms, study trackers, protocols and consent forms, and other moderately complicated study documents
6) Coordinator A: CRC A will not oversee research assistants but may train the assistants on their study. Attend Investigator Meetings and communicate meeting information to the study team.
Coordinator B: With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
7) Perform additional duties as assigned.
Clinical Research Coord A: Bachelor's Degree and 1-3 years of experience or equivalent combination of education and experience required
Clinical Research Coord B: Bachelor's Degree and 2-4 years of experience or equivalent combination of education and experience required
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
Affirmative Action Statement
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