Study Coordination & Project Management
Fee-for-service resources comprised of research nurses, study coordinators, regulatory coordinators, project managers, data specialists, and recruitment specialists available to investigators to support every aspect in the research process.
Resources act as a “float pool” of experienced research staff who are available to help conduct studies at all UH sites, non-UH sites, and outside institutions. Expertise in both pediatric and adult patient populations, and also in the ambulatory, inpatient, and emergency medicine settings.
- Dedicated study staff with expertise in all responsibilities of protocol implementation and project management.
- Comprehensive knowledge of protocol requirements, Good Clinical Practice, and Federal regulations.
- In collaboration with the Principal Investigator and study team, manage research studies from the start-up process through study completion.
- Coordinate and conduct study visits and procedures according to protocol to ensure compliance, subject safety, and data integrity.
- Capable of providing 24/7 coverage across the entire institution, including the Emergency Department and inpatient units.
- Submit and maintain IRB and regulatory documents in accordance with local IRB and FDA regulations.
- Continuous protocol-specific training and education for investigators, study team, ancillary services, and applicable clinical support staff.
- Perform all activities related to clinical research studies including but not limited to:
- Study start-up
- Screen participants for eligibility
- Obtain informed consent and assent
- Educate participants regarding study requirements
- Conduct all study visits and procedures in compliance with the protocol
- Maintain complete and accurate study files
- Protocol development and grant application support
- Assist with study budget development to ensure proper funds for all services and resources through the life of the study.
- Support for rapid study start-up, implementation, and close-out.
- Engage with Sponsor and representatives to coordinate and conduct site qualification visits, site selection visits, site initiation visits, routine monitoring visits, close-out visits, attend investigator meetings, and Sponsor-initiated audits.
- Ongoing communication with Sponsor and representatives to report protocol deviations and adverse events, provide screening and enrollment updates, receive protocol guidance and clarification, and to ensure study is carried out in an efficient and compliant manner.