Clinical Researcher Coordinator B/C

Clinical Researcher Coordinator B/CAs part of the Infectious Disease Clinical Trials Group, this position will coordinate clinical research consisting of projects in HIV 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. Prior experience in gene therapy clinical trials is ideal but not required. Work requires on-site presence and interaction with research subjects. 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 ResponsibilitiesScreen, recruit, and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants across infectious disease and gene therapy protocols.Coordinator B: Participate in and coordinate clinical trials within the Penn Division of Infectious Disease Clinical Trials Unit, consisting of projects in HIV 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 (including specialized gene therapy protocols).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, including 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.Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA, and GCP guidelines.Coordinator C: The Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the program manager. In addition, will develop complex documents such as protocols and consents (specifically incorporating gene therapy workflows and endpoints), 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 with a higher degree of independent judgment Conduct study-related visits, including procedures such as blood draws, vitals, medical history, ECGs, specialized gene therapy protocol administration/monitoring, and processing of biological specimens; manage study data and regulatory files per GCP. 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. Correspond regularly with the Institutional Review Board and other regulatory agencies (including IBC/gene therapy oversight bodies as applicable), including preparation and submission of protocols, protocol amendments, SAE reports, and DSMB subject narratives.Position contingent on funding.QualificationsEffective 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; highly reliable and good work ethic required. Recent experience with phlebotomy preferred.• Coordinator B: Bachelor's degree required and 2–4 years of related clinical research experience (or equivalent combination of education and experience).• Coordinator C: Bachelor's degree required and 4+ years of related clinical research experience (or equivalent combination of education and experience)Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$53,418.00 - $63,085.00 Annual RateSalary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.Equal Opportunity StatementThe 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.Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.