- 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.
- Conducts protocols pertaining to human research under the direction of PIs.
- Coordinates and oversees the implementation of clinical research studies according to established standards and protocols.
- Recruits, retains, enrolls human subjects keeping NIH and lab timelines.
- Ensures compliance with regulatory requirements, including HIPAA guidelines.
- Manages and maintain accurate and up-to-date study documentation.
- Performs data management tasks, including data entry, analysis, and reporting.
- Conducts human studies with appropriate use of SOPs, program manuals follow through using proper GCP and Human subject's protection guidelines, and document work appropriately in electronic folders.
- Places IVs, prepare medications, and conduct studies in the Clinical Research Unit at UAB.
- Adheres to institutional policies, attention to research safety and integrity; safety of participants comes first.
- Collects and records patient data, including vital signs and medical history.
- Assists with blood sampling and phlebotomy procedures as needed.
- Monitors study participants for adverse events and report findings to the appropriate parties.
- Maintains confidentiality of patient information and study data.
- Collaborates with healthcare professionals, including nurses and physicians, to ensure proper patient care during research studies.
- Submission for IRB, radiation safety, and CCTS approvals as needed.
- Submission for FDA -IND/IDE, other regulatory work as per PI.
- Prepare annual enrollment reports for NIH, FDA, and others.
- Work under the supervision of MDs and other post-doctoral fellows.
- Performs other duties as assigned.
- Certification by SOCRA is a plus.
- Strong working knowledge of clinical research processes, regulations, and guidelines.
- Strong attention to detail and organizational skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a team environment.
- Proficiency in using computer systems for data management and analysis. Familiarity with phlebotomy procedures is a plus.
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Clinical Research Nurse Coordinator II - University, United States - University of Alabama at Birmingham
Description
The Clinical Research Nurse Coordinator II will support the Division of Endocrinology, Diabetes and Metabolism in various clinical research initiatives, primarily coordinating for the research of Drs.
Rita Basu, Ananda Basu and Fernando Ovalle.General Responsibilities
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.
Preferred Qualifications
