The University of Alabama at Birmingham (UAB), Department of Med - Endocrinology, Diabetes & Metabolism, is seeking a Clinical Research Nurse Coordinator II. This position will support the Division of Endocrinology, Diabetes, and Metabolism in various clinical research initiatives, primarily coordinating the research of Drs. Rita Basu, Ananda Basu and Fernando Ovalle.

General Responsibilities

• 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.

Key Duties & Responsibilities

1. Conduct protocols pertaining to human research under the direction of PIs.
2. Coordinate and oversee the implementation of clinical research studies according to established standards and protocols.
3. Recruit, retain, and enroll human subjects keeping NIH and lab timelines.
4. Ensure compliance with regulatory requirements, including HIPAA guidelines.
5. Manage and maintain accurate and up-to-date study documentation.
6. Perform data management tasks, including data entry, analysis, and reporting.
7. Submission for IRB, radiation safety, and CCTS approvals as needed.
8. Submission for FDA -IND/IDE, other regulatory work as per PI.
9. Prepare annual enrollment reports for NIH, FDA, and others.
10. Conduct human studies with appropriate use of SOPs, program manuals follow through using proper GCP and Human subject protection guidelines, and document work appropriately in electronic folders.
11. Place IVs, prepare medications, and conduct studies in the Clinical Research Unit at UAB.
12. Adhere to institutional policies, attention to research safety and integrity; safety of participants comes first.
13. Collect and record patient data, including vital signs and medical history.
14. Assist with blood sampling and phlebotomy procedures as needed.
15. Monitor study participants for adverse events and report findings to the appropriate parties.
16. Maintain confidentiality of patient information and study data.
17. Collaborate with healthcare professionals, including nurses and physicians, to ensure proper patient care during research studies
18. Performs other duties as assigned.

Annual 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.

Preferences

• 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.