Clinical Researcher Coordinator B/C

University of Pennsylvania Perelman School of Medicine

60d•$53,418 - $63,085•Onsite

About The Position

As 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.

Requirements

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 required
Bachelor’s degree required and 2–4 years of related clinical research experience (or equivalent combination of education and experience) for Coordinator B
Bachelor’s degree required and 4+ years of related clinical research experience (or equivalent combination of education and experience) for Coordinator C

Nice To Haves

Prior experience in gene therapy clinical trials is ideal but not required.
Recent experience with phlebotomy preferred.

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.
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.
Support Infectious Disease Investigators in clinical research ranging from observational trials to investigational product trials, including both investigator-initiated and industry-initiated trials.
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.
Perform the duties of a Clinical Research Coordinator B with more limited supervision from the program manager.
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.
With supervision, assist in preparation of research protocols and documents.
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).
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.
A CRC C will be expected to manage/coordinate/organize the daily work of research assistants independently.
Perform additional duties as assigned.

Benefits

Excellent healthcare benefits
Tuition benefits for employees and their families
Generous retirement benefits
Wide variety of professional development opportunities
Supportive work and family benefits
Wealth of health and wellness programs and resources
Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
Flexible spending accounts
Tuition assistance at Penn and other institutions for dependent children
Retirement plans (Basic, Matching, and Supplemental)
Substantial amount of time away from work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development resources
Access to a wide range of University resources as well as cultural and recreational activities
Discounts and Special Services
Flexible Work Hours
Penn Home Ownership Services
Adoption Assistance