Senior Manager, Clinical Research Nursing

Department:

Location:

Health Sciences Center

Time Type:

Full time

Worker Type:

Regular

Job Req ID:

R107287

Minimum Requirements:

Master's degree in a related field and two (2) or more years of related experience including four years of clinical experience. Must have a Kentucky RN license in good standing. Additional experience may be used on a one-to-one basis to offset the educational requirements. Grade 10 (Salaried)

Position Description:

Under the guidance of the Director, Research and Support ("CTP") and leadership, this position works collaboratively and proactively in alignment with the Mission of the CTP and Brown Cancer Center (“BCC”) to ensure the overall success of the clinical trials program of the BCC. This position manages the clinical conduct of a complex array of oncology and hematology treatment trials, involving multiple investigators, teams, sponsors, and departments. This position is responsible for recruiting, hiring, orienting, training, supervising and mentoring clinical research staff for the CTP and monitoring the staff's workloads and adjusting work assignments particularly in an environment of increasing numbers of complex treatment trials and increasing accruals. In collaboration with CTP managers and staff, this position is responsible for ensuring that the practices and activities of the BCC CTP are in compliance with relevant state and federal regulations, Good Clinical Practice (GCP) as well as with University of Louisville policy by designing, assessing, and implementing program level policies and procedures that ensure compliance as well as ethical conduct of research.  This position must design and implement an internal auditing program in order to test compliance with the above. In addition, this position is responsible for the design and implementation of a program of continuing education and advancement for CTP staff, including but not limited to attendance at seminars and conferences, online trainings, purpose designed in-person training when necessary (i.e. training or refresher training on policies and procedures) to ensure the continued competency of BCC staff, as well as meeting the educational needs of newly hired staff as relates to policy and procedure.  This position must be able to work collaboratively without "silos," and be able to propose and implement new initiatives. 

Essential Duties:

• Oversee and manage the daily activities of the BCC Clinical Trials Program clinical staff in conduct of a complex array of oncology and hematology research studies involving multiple investigators, study teams, sponsors and departments to ensure studies are conducted according to Good Clinical Practice, the protocol, and expected timelines

• Manages a team of Clinical Research Coordinators and Research RNs through good management principles (e.g. best use of resources, continuous improvement, and ownership)

• Advise team members in supervisory positions on issues related to the clinical conduct of trials on an as-needed basis.

• Develops policies and procedures related to management of the CTP as well as compliance with all relevant regulations and guidelines.

• Evaluates, develops, and improves systems and processes

• Collaborate with colleague CTP managers, CTP leadership, and Principal Investigators to develop clinical trial programs that meet the needs of BCC patients.

• Serves as liaison between the CTP and those involved in direct patient care at partner facilities to ensure adherence to all policies and procedures related to research compliance, privacy standards and quality measures.

• Serve on various clinical trial related committees of the Brown Cancer Center

• Stay current with clinical research regulation, compliance requirements, and staff needs to develop a program of continuing education to ensure that all staff at the BCC are kept abreast of changes to regulation and compliance requirements, including internal policy and procedure changes.

• Take a leadership role in design and implementation of staff training programs; including but not limited to new hire orientation/research basics, software training, annual training refreshers.

• Assist in the implementation of new software for use by the BCC Clinical trials program.

• Develop and implement an internal compliance auditing program designed to identify weaknesses in BCC CTP program in relation to compliance and data integrity.

• Lead preparation for external audits, including preparation of relevant records and affected staff.

Preferred Qualifications:

• Existing SOCRA certification

• Master’s Degree in a relevant field (e.g., MSN, MBA, MPH, MA-BE, or MHA)

• Minimum of 5 years of