CLINICAL RESEARCH ADMINISTRATOR II

The University of Alabama at Birmingham (UAB), Med - Infectious Diseases, is seeking a Clinical Research Administrator II.

The Clinical Research Administrator II will complete ongoing studies with active patients enrolled for which we have a commitment to meet our obligations, and then conclude the study fully. We are looking for an administrative responsible for an 80-site, international clinical trials group. This involves a deep working knowledge of clinical trials in mycology and managing the complex relationships inherent to such a large clinical trial network. As such, the candidate's role also includes frequent communication with national and ex-US site PIs and the site team relating to challenges such as enrollment goals and problems with enrollment, logistical obstacles such as international specimen handling and shipping, and remote data monitoring in selected studies. In the event that a site is underperforming or data quality is poor or questionable, then the candidate must intervene on behalf of the PI and/or study sponsor to reconcile these issues. Finally, the candidate is responsible for site initiation visits for each new clinical trial for which the UAB/MSG is the lead site. Taken together, this is an enormous responsibility that is significantly of importance for the MSG Team.

General Responsibilities

• To demonstrate a comprehensive understanding of contract principles, federal regulations, laws and UAB policy and operating procedures.
• To serve as liaison to the UAB Offices of Industry Engagement and Sponsored Programs in negotiation of confidentiality agreements (CDAs), contracts, and amendments related to the conduct of clinical research activities.
• To identify conflicts of interest, legal, IP and business/financial risk.
• To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.

Key Duties & Responsibilities

1. Serves as liaison to the UAB Offices of Industry Engagement and Sponsored Programs in negotiating confidentiality agreements (CDAs), contracts, and amendments related to the conduct of clinical research activities.
2. Assists in preparing, developing, reviewing and negotiating industry and sponsored research clinical trial budgets for consistency with UAB policies and operating procedures.
3. Identifies and obtains funding sufficient to successfully execute clinical research as applicable.
4. Assists in managing accounts across studies as needed.
5. Maintains study's compliance with institutional requirements.
6. Conducts literature reviews.
7. Assesses and determines solutions for operational shortcomings of protocols.
8. Assists colleagues in identifying efficiencies and improving process.
9. Performs other duties as assigned.

Annual Salary Range: $47,665 - $77,455

Qualifications

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



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, 205-5493, amcdew@uab.edu.