T219405 - University of Alabama at Birmingham

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Administrator III. The CRA III duties include pre-award activities for the Clinical Trials Office Reviews protocol, ICF, Sponsor's budget and any other study documents required to build the initial calendar. Completes RedCap submission to FAP. This also includes submission to CCTS and Tissue Procurement Submissions Reviews protocol amendments as they occur and makes any necessary changes to billing plan, then resubmits back to FAP Ancillary Department Submissions (i.e. Radiology, CCTS, Tissue Procurement). Onboarding/training new FAP submitters. Review of studies with clinical research coordinators.

The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https://www.uab.edu/onealcancercenter/

Please attach a current resume with this application.

General Responsibilities

• To act as a resource for faculty and staff regarding administrative duties for industry and sponsored clinical research.
• To serve as an informational and referral resource for the clinical research community.
• To work with necessary parties to identify compliance, legal, IP and business/financial risk.
• To manage accounts across all studies as needed.
• To process and analyze reports in OnCore, as needed.

Key Duties & Responsibilities

1. Acts as a resource for faculty and staff regarding administrative duties for industry and sponsored clinical research.
2. Serves as an informational and referral resource for the clinical research community.
3. Works with necessary parties to identify compliance, legal, IP and business/financial risk.
4. Manages accounts across all studies as needed.
5. Conducts literature reviews. Assesses and determines solutions for operational shortcomings of protocols. Determines operational elements needed for conduct of clinical studies.
6. Trains staff in various work responsibilities, as needed. Provides training to office personnel in ethical conduct of research.
7. Contributes to strategic planning within the respective Department or School, as needed.
8. Maintains currency in field through cross training, continuing education, literature and seminars in order to implement this knowledge and create efficiencies within the Department.
9. Processes and analyzes reports in OnCore, as needed.
10. Reviews protocol, ICF, Sponsors budget and any other study documents required to build initial calendar.
11. Completes RedCap submission to FAP. This also includes submission to CCTS and Tissue Procurement Submissions
12. Reviews protocol amendments as they occur and makes any necessary changes to billing plan, then resubmits back to FAP.
13. Ancillary Department Submissions (i.e. Radiology, CCTS, Tissue Procurement).
14. Onboarding/training new FAP submitters.
15. Review of studies with clinical research coordinators.
16. Performs other duties as assigned.

Annual Salary Range:%2455,180 - %2489,670

Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.

Preferences

• The ideal candidate must be able to effectively interface professionally between Principal Investigators, Study Coordinators, Regulatory Managers, Financial Associates, Grants and Contracts Officers, Clinical Billing Review Officers, Ancillary Departments, and Sponsor regarding clinical trial activities relating to budgets and contracts to assure Cancer Center investigators needs are achieved and goals accomplished. Full understanding of the Fiscal Approval Process (FAP).

Key Skills

• Problem-solving skills
• Working knowledge of related scientific and clinical terminology
• Leadership skills
• Presentation skills
• Prioritization skills Organizational skills
• Written and verbal communication skills.

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 veteranrsquo;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 UABrsquo;s Assistant Vice President and Senior Title IX Coordinator, the U.S. Department of Educationrsquo;s Office for Civil Rights, or both. UABrsquo;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.