The University of Alabama at Birmingham (UAB), OB/GYN - Maternal & Fetal Medicine, is seeking a Clinical Research Coordinator II.

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. Maintains compliance with federal, state, and accrediting agencies (sponsors).
7. Maintains any required documentation.
8. Coordinates patient care and/or patient follow-up functions of the clinical study including planning and developing related activities.
9. Arranges access to study medications, including authorization for prescriptions.
10. Employs strategies to maintain recruitment and retention rates.
11. Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
12. Manages investigational products (IP).
13. Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
14. In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives.
15. Compiles, edits, and proofs written reports for both internal and external administrative offices.
16. Provides data for the creation of study budgets as needed.
17. Completes Case Report Forms (CRF) according to protocol.
18. Assists with the development of standard operating procedures (SOPs) for data quality assurance.
19. Performs vendor analysis and equipment configuration as needed.
20. May perform a variety of medical procedures.
21. Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes.
22. Arranges multidisciplinary evaluations.
23. Processes and maintains lab specimens and manages site supplies as needed.
24. Serves as a mentor to junior staff, including student assistants.
25. Performs other duties as assigned.

Annual Salary Range: $50,050 - $81,330

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

Preferences

• Effective verbal and written communication skills, as well as a willingness to work within a group setting.

The University of Alabama at Birmingham (UAB) is an Equal Employment/Equal Educational Opportunity Institution. UAB is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, religion, sexual orientation, gender identity, gender expression, and veteran’s status. Title IX of the Educational Amendments of 1972 protects individuals from discrimination based on sex in any educational program or activity operated by recipients of federal financial assistance. As required by Title IX, UAB does not discriminate based on sex in its educational programs or activities, including in admission and employment. Inquiries concerning the application of Title IX may be referred to UAB’s Assistant Vice President and Senior Title IX Coordinator, the U.S. Department of Education’s Office for Civil Rights, or both. UAB’s Assistant Vice President and Senior Title IX Coordinator is Andrea McDew, 701 20th Street South, Suite 1030, Birmingham, AL 35233, 205-934-5493, amcdew@uab.edu.