Clinical Researcher Coordinator B/C

The University of Pennsylvania is a world-renowned university and research institution. The Clinical Research Coordinator B/C will coordinate infectious disease and gene therapy clinical trials, supporting study implementation, regulatory submissions, patient recruitment, study visits, data management, and compliance. The role also involves developing study documents, managing research activities, and coordinating with investigators, regulatory bodies, sponsors, and clinical research organizations.

Responsibilities

• Screen, 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. Assist in the development/maintenance of study-specific case report forms and source document tools. 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
• Coordinator B: With supervision, assist in preparation of research protocols and documents
• Coordinator C: Work with primary investigators to develop investigator-initiated protocols, case report forms, and databases. Independently design research documents including consent forms, source documents, CRFs, and training SOPs for complex trials (including gene therapy)
• Coordinator B: With the help of the program 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
• Coordinator C: A CRC C will be expected to do this independently
• Perform additional duties as assigned

Preferred

• Recent experience with phlebotomy preferred
• Phlebotomy

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits for employees and their families.
• Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition assistance for the employee, spouse, and dependent children at Penn; dependent children are also eligible for tuition assistance at other institutions.
• Basic, Matching, and Supplemental retirement plans with pre-tax or Roth savings options and investment options through TIAA and Vanguard.
• Substantial time away from work during the year for vacations, personal affairs, illness or injury, and time with family.
• Long-term care insurance for faculty and staff and eligible family members; newly hired employees who apply do not have to provide proof of good health or undergo underwriting requirements, while eligible family members are subject to underwriting.
• Wellness and work-life programs and resources to support health, family, and work-life balance.
• Professional and personal development resources.
• Access to University resources, libraries, athletic facilities, cultural and recreational activities, with many activities available for free to employees and their families.
• Discounts and special services, including free and discounted admission and memberships at Penn arts and cultural centers and museums, and savings on goods and services.
• Flexible work options involving non-traditional work hours, locations, and/or job structures.
• Forgivable loan for eligible employees buying a home or currently residing in West Philadelphia, for closing costs or home improvements.
• Adoption assistance reimbursing eligible employees for qualified expenses related to the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in the household.

Company

• Ivy League university offering undergraduate and graduate education
• Philadelphia, Pennsylvania, USA
• http://www.upenn.edu/
• Founded in 1740
• 10001+ employees

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
• highly reliable and good work ethic
• 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)
• 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
• 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)

Required skills

• Clinical Practice (GCP), Clinical Research, Gene Therapy Clinical Trials, Human Research Protection Regulations, IRB Regulations, Phlebotomy

Preferred skills

• Recent experience with phlebotomy preferred

Experience

• 2+ years