MANAGER-CLINICAL RESEARCH NURSING

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

• Creates documents related to patient safety and security.
• Provides division-wide training in ethical conduct of clinical research.
• 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.
• Assists with the development of protocols.
• Sets up 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.
• 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.
• Makes sure the environment of care, including equipment and material resources, is maintained.
• Initiates and/or assists with developing and revising policies and procedures for nursing practice.
• 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.

Pay

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

Qualifications

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

Education

• BSN degree.

Knowledge

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

Physical Demands

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