MANAGER-CLINICAL RESEARCH NURSING

University of Alabama at Birmingham•University, MS

55d

About The Position

The University of Alabama at Birmingham (UAB), Med - Pulmonary/Allergy/Critical Care is seeking a Manager-Clinical Research Nursing. This position will be responsible for the management of the ICU clinical trials research program within the Pulmonary and Critical Care Division. The position will be responsible for all aspects of trial conduct start-up through close-out. 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.

Requirements

Bachelor's degree in a related field and eight (8) years of related experience required.
Work experience may NOT substitute for education requirement.
Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.

Nice To Haves

Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
The ideal candidate will possess excellent nursing skills and in-depth knowledge of clinical trials management at UAB and in the inpatient setting.
Will be a motivated self-starter with the ability to help develop teams and work with staff and faculty at all levels.

Responsibilities

Oversees conduct of 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.
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.
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.
Creates documents related to patient safety and security and the ethical conduct of clinical research.
Uses and 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.
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.
Collaborates with administrative personnel to establish financial monitoring systems involving clinical research and patient care activities.
Directs the performance of study audits and monitoring activities to ensure compliance with all clinical regulatory aspects of the research.
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.
Performs other duties as assigned.