Job Information
University of Pittsburgh Clinical Research Coordinator II in Pittsburgh, Pennsylvania
Clinical Research Coordinator II Job Summary
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.
Essential Functions
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.
Physical Effort
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.
Assignment Category: Full-time regular Job Classification: Staff.Clinical Research Coordinator II Job Family: Research Job Sub Family: Clinical Research Campus: Pittsburgh Minimum Education Level Required: Bachelor's Degree Minimum Years of Experience Required: 2 Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement. Work Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m. Work Arrangement: Monday - Friday, 8:30 a.m. - 5:00 p.m. Hiring Range: TBD Based Upon Qualifications Relocation_Offered: No Visa Sponsorship Provided: No Background Check: For posit on finalists, employment with the University will require successful completion of a background check Child Protection Clearances: Not Applicable Required Documents: Resume Optional Documents: Not Applicable PI239316237