Clinical Research Manager jobs in Alabama

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Manager-Clinical Research Nursing. This position will provide oversight and management for the day-to-day efforts of the Cancer Center Clinical Trials Office focused primarily on breast cancer research coordination in conducting study activities including complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).

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 conduct and understand all study activities in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).
• To manage the life cycle of the clinical trial from study start-up through trial maintenance to study closure.
• To coordinate and organize patient care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.

Key Duties & Responsibilities

1. Assists with the management of the life cycle of the clinical trial as needed from study start-up through trial maintenance to study closure.
2. Oversees and/or manages multiple complex breast cancer clinical research protocols and the associated personnel.
3. Serves as a resource person or acts as a subject matter expert (SME) within area of clinical expertise.
4. Responsible for attending working group meetings and contributing to discussions regarding new clinical trials from a nursing and coordination point of view.
5. Collaborates with leadership of the Cancer Center Clinical Trials Office to ensure accountability for effective management of timelines and resources for assigned clinical studies and implementation of appropriate standards and processes.
6. Works with principal investigators to ensure proper oversight trial conduct and data quality assurance.
7. Assists in implementing process improvement plans to improve trial management and time to activation.
8. Develops reports and assists unit leadership as needed.
9. Collaborates with other research units across campus as well as sponsors, investigators, study personnel, participants, health care providers, and Departmental leadership.
10. Works effectively with budget and finance and regulatory to ensure proper budgeting, billing and compliance for the trials coordinated by the group.
11. Assists in developing standard operating procedures (SOPs) for data quality assurance.
12. Directs the performance of study audits and monitoring activities to ensure compliance with all clinical regulatory aspects of the research.
13. Responsible for performance evaluations, time off requests, evaluating and managing the workload of Phase I and research nurse coordinators and data coordinators as well as for sustainability of staff including training/mentoring new staff.
14. Performs other duties as assigned.

Annual Salary Range: $77,640.00 - $126,170.00

• Bachelor's degree in a related field and eight (8) years of related experience required.

Work experience may NOT substitute for education requirement.

Licenses / Certifications / Registrations

• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
• Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.

Preferences

• Breast cancer nursing and research experience required.
• Demonstrated experience staffing, resourcing and scheduling clinical study coordinator teams to meet the needs of a diverse portfolio of research studies, including Sponsors', investigator's and patient needs.