"CLINICAL RESEARCH COORDINATOR II"

Job Description

The University of Alabama at Birmingham (UAB), Med - Infectious Diseases, is seeking a Clinical Research Coordinator II. This position is responsible for providing supplemental support for clinical trials at the Alabama Clinical Trials Unit (CTU) under the guidance of the CTU Principal Investigator and CTU Coordinator. This includes assisting with study-related tasks as needed and provision of clerical and/or clinical support to other senior staff.

General Responsibilities

• To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
• To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
• To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
• To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

1. Serves as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities.
2. Organizes patient enrollment planning.
3. Conducts quality assurance activities.
4. Compiles and analyzes data.
5. Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
6. Coordinates patient care and/or patient follow-up functions of the clinical study, including planning and developing related activities.
7. Arranges access to study medications, including authorization for prescriptions.
8. Employs strategies to maintain recruitment and retention rates.
9. Prepares and submits multiple levels of research documentation (i.e., IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
10. Manages investigational products (IP).
11. Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
12. In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives.
13. Compiles, edits, and proofs written reports for both internal and external administrative offices.
14. Provides data for the creation of study budgets as needed.
15. Completes Case Report Forms (CRF) according to protocol.
16. Maintains compliance with federal, state, and accrediting agencies (sponsors).
17. Maintains any required documentation.
18. Processes and maintains lab specimens.
19. Manages site supplies as needed.
20. Develops protocols, identifies efficiencies, and improves processes.
21. Serves as a mentor to junior staff, including student assistants.
22. Arranges multidisciplinary evaluations.
23. Performs other duties as assigned.

Qualifications

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferences

Preferred Knowledge, Skills, Abilities: Creativity, Written and oral communication, Public speaking, Organization, Time management, Attention to detail, Proficiency with MS Office programs, Working knowledge of social media other online platforms. Implementation of the Alabama CTU Clinical Quality Management Plan, which includes but is not limited to: Collect and/or record data or other information for clinical trials and clinic operations. Conduct clinical and clerical duties related to trial implementation and/or clinic flow. Assist in the coordination of lab specimen collection and/or delivery. Conduct medical procedures under supervision as applicable. Follow established SOPs and clinic operation procedures. Skills: include phlebotomy skills, all system mastery, including orders in the Electronic Health Record, expertise using all internal systems, including working with pharmacy and prescribers for study product provision, and the ability to delegate other RN and clinician tasks.

Annual Salary Range

$50,050 - $81,330