Southeast HERC

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Manager-Clinical Research Nursing.

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 oversee staff in conducting all study activities including more complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).

• To assist with the management of the life cycle of the clinical trial as needed from study start-up through trial maintenance to study closure.

• To oversee and/or manage multiple clinical research protocols and the associated personnel.

• To serve as a resource person or act as a subject matter expert (SME) within area of clinical expertise.

Key Duties & Responsibilities

1. The Manager-Clinical Research Nursing oversees staff in conducting all study activities, including more complex protocols, in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP). Assists staff in managing 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 clinical research protocols and the associated personnel. Serves as a resource person or acts as a subject matter expert (SME) within the area of clinical expertise.

3. Creates documents related to patient safety and security. Provides division-wide training in ethical conduct of clinical research.

4. Trains staff in the use of Electronic Data Capture (EDC) systems and Case Report Forms (CRF). Conducts periodic internal audits of fields in the OnCore CTMS to ensure compliance with institutional requirements. Develops reports and assists unit leadership as needed. Develops standard operating procedures (SOPs) for data quality assurance.

5. Assists with the development of protocols. Assigns, reviews, and trains staff in study operations. Mentors junior staff. Collaborates with other research units across campus as well as sponsors, investigators, study personnel, participants, health care providers, and Departmental leadership.

6. Collaborates with administrative personnel to establish financial monitoring systems involving patient care activities. Directs the performance of study audits and monitoring activities to ensure compliance with all clinical regulatory aspects of the research.

7. Monitors and initiates corrective action to maintain the environment of care, including equipment and material resources. Initiates and/or assists with developing and revising policies and procedures for nursing practice.

8. Manages project organization, including coordination of internal and external regulations and guidelines affecting clinical research. Designs best practices for management of IP for drug, device, and biologic studies. Creates and evaluates study budgets.

9. Performs other duties as assigned.

Annual Salary Range: $85,600 - $139,100

Bachelor's degree in a related field and eight (8) 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. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.

Preferences

Hard skills: clinical trial, clinical research and data management, protocol compliance management, educating patients and family concerning medical conditions

Soft skills: management, problem-solving, critical thinking, teamwork, organizational, leadership, communication, flexibility, and emotional intelligence.

• BSN degree.

• Knowledge of Oncology, clinical research, protocol, and clinical trial management.

• Generally, may walk approximately one mile a day and lift 5 pounds daily.
  

UAB is an Equal Employment/Equal Educational Opportunity Institution 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, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.