Posted in Other 4 days ago.
Clinical Research Coordinator B/C (Division of Infectious Diseases)
University Overview
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Posted Job Title
Clinical Research Coordinator B/C (Division of Infectious Diseases)
Job Profile Title
Clinical Research Coordinator B
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. Position is partially funded by the Operation Warp Speed federal program to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
Research coordinator work includes study implementation, document development, submission to regulatory boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.
Job Description
Research coordinator work includes study implementation, document development, submission to regulatory boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.
Duties:
Clinical ResearchCoordinator B: Participate in and coordinate clinical trials within the Penn Division of 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.
Coordinator duties include:
Assist in development of study documents. Communicate with study team members and regulatory review boards. 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.
The Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the project manager. In addition, will develop complex documents such as protocols and consents, lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up and execute studies. Accountable for making sure study timelines and goals are met. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Management of clinical trials and will need to use more independent judgment.
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. Recent experience with phlebotomy preferred. Position contingent on funding.
CRC-B
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
CRC-C
Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$43,919.00 - $77,000.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
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