2024-04-10
University of Pittsburgh
Other
/yr
employee
contract
Pittsburgh
Pennsylvania
15260
United States
Clinical Research Coordinator II-Altoona Location
Conducts research assessments on study participants. Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Assists with training staff. Ensures adherence to protocols and corrects issues with data collection.
***This position is located in our Wound Care facility in Altoona, PA***
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. Scheduling of patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug. Maintains accurate source documents related to all research procedures. Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. Schedules and participates in monitoring and auditing activities. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. May involve other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board). Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May participate in centralized activities such as auditing, Standard Operating Procedure development, etc. May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. Participates in required training and education programs.
Requires sitting, standing, walking, and lifting up to 25 lbs. Travel between locations is required.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
PI239316210
