University of Pennsylvania
Ivy League university in Philadelphia, PA
Clinical Research Coordinator - Infectious Disease Clinical Trials Group
Full-Time
$53.4k - $63.1k/yr
Mid
Bachelor's
Philadelphia, PA, USA
In Person
On-site presence and interaction with research subjects are required.
About the job
Requirements
- A bachelor's degree is required.
- Coordinator B requires 2–4 years of related clinical research experience, or an equivalent combination of education and experience.
- Coordinator C requires 4 or more years of related clinical research experience, or an equivalent combination of education and experience.
- Knowledge of Institutional Review Board and human research protection regulations is required.
- Effective problem-solving, communication, and writing abilities are required.
- Strong organizational and time-management skills, flexibility, multitasking ability, and attention to detail are required.
- The ability to work both as part of a team and independently is required.
- Reliability and a strong work ethic are required.
Responsibilities
- Screen, recruit, and enroll consenting patients using Good Clinical Practice guidelines.
- Conduct compliance monitoring of study participants across infectious disease and gene therapy protocols.
- Participate in and coordinate clinical trials involving HIV and other infectious diseases, including observational, investigational product, investigator-initiated, and industry-initiated trials.
- Assist in developing study documents and 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 necessary testing, and conduct patient visits.
- Monitor patients according to protocol requirements and ensure adherence to those requirements.
- Organize and maintain documentation required by the investigator, sponsor, or contract research organization, 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 study initiation, monitoring, audit, and close-out visits.
- Participate in study team meetings and ongoing protocol training.
- Assist in developing and maintaining study-specific case report forms and source-document tools.
- Maintain vigilance regarding patient safety, protocol compliance, and data quality.
- Adhere to University of Pennsylvania, Food and Drug Administration, and Good Clinical Practice guidelines.
- For Coordinator C, perform clinical-trial duties with limited supervision, develop complex protocols and consent documents incorporating gene therapy workflows and endpoints, lead team meetings, and lead study communications with internal and external groups.
- For Coordinator C, work directly with investigators to design, set up, and execute studies; ensure study timelines and goals are met; and independently move clinical trials through each phase of development while resolving issues and queries with supervisory input as needed.
- Conduct study-related visits, including blood draws, vital signs, medical histories, electrocardiograms, specialized gene therapy protocol administration and monitoring, and biological-specimen processing.
- Manage study data and regulatory files according to Good Clinical Practice requirements.
- Prepare for audits, review regulatory binders, perform internal audits and other quality-assurance activities, and handle monitor and audit visits with contract research organizations, the Food and Drug Administration, and other entities.
- Correspond with the Institutional Review Board and other regulatory agencies, including institutional biosafety and gene therapy oversight bodies as applicable, and prepare and submit protocols, protocol amendments, serious adverse event reports, and Data and Safety Monitoring Board subject narratives.
- For Coordinator C, develop investigator-initiated protocols, case report forms, and databases with primary investigators, and independently design consent forms, source documents, case report forms, and training standard operating procedures for complex trials.
- Coordinate or independently organize the daily work of research assistants for recruitment, study visits, and regulatory tasks, train them in these tasks, attend investigator meetings, and communicate meeting information to the study team.
- Perform additional duties as assigned.
Desired Qualifications
- Prior experience in gene therapy clinical trials is ideal but not required.
- Recent experience with phlebotomy is preferred.
About the company
The University of Pennsylvania is a private Ivy League research university in Philadelphia. It comprises twelve undergraduate, graduate, and professional schools, including the Wharton School, Perelman School of Medicine, and Penn Carey Law.
Company Size
N/A
Company Stage
N/A
Total Funding
N/A
Headquarters
N/A
Founded
N/A
Get referred to University of Pennsylvania
See people who can refer or advise you