- To serve as primary coordinator for clinical research studies and supporting more senior team members.
- To provide a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance. May provide oversight to junior clinical research coordinators (CRC) and clinical research nurse coordinators (CRNC) in review of study documents.
- To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP).
- To provide quality care to participants and their families within the area of clinical specialty.
- To coordinate the life cycle of the study from start-up through maintenance to closure.
- To manage participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
- To perform the informed consent process following GCP.
- To act as a liaison between the clinical and research staff, departments, ancillary services and the study sponsor to ensure protocol compliance throughout the study.
- Assist Principal Investigator with subject recruitment, consenting process, study enrollment, and follow-up. Assist other clinical staff with coordinating, organizing, and implementing multiple studies being conducted as part of a multi-site clinical trials group
- Data and specimen collection, and data entry for subject into an electronic data system in accordance with established research protocols. Track families for follow up visits by means of phone calls, letters, etc. to ensure babies are seen for required follow up visits and perform study specific follow up requirements for each study.
- Preparation, submission, and maintenance of required study-related regulatory documents to the IRB, Conflict of Interest Board, and FDA for all studies being conducted by the site. Activities include maintaining study files and project notebooks to ensure that all federal requirements are met
- Maintaining up to date patient lists in Oncore system to ensure clinical billable items are charged appropriately.
- Performs other duties as assigned.
- Ability to communicate effectively
- Interpersonal skills
- Leadership skills
- Time Management Skills
- Comprehensive understanding of related scientific and clinical terminology
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Clinical Research Nurse Coordinator II - University, United States - University of Alabama at Birmingham
Description
The University of Alabama at Birmingham (UAB), Department of Ped - Neonatology, is seeking a Clinical Research Nurse Coordinator II.
General ResponsibilitiesAnnual Salary Range:
$60,835 - $98,855
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.
Key Skills
