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Clinical Research Coordinator A/B (Infectious Disease Clinical Trials Group)
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Posted Job Title
Clinical Research Coordinator A/B (Infectious Disease Clinical Trials Group)
Job Profile Title
Clinical Research Coordinator A
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 Description
Job Responsibilities
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.
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.
Coordinator A: Bachelor's degree required and 1-2 years of related experience (or equivalent combination of education and experience). Phlebotomy preferred.
Coordinator B: Bachelor's degree required and 2-4 years of related experience (or equivalent combination of education and experience). Phlebotomy preferred.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$37,220.00 - $58,000.00 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.
University Benefits
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