Manager, Cancer Clinical Trials Office

This is a high visibility position within a prestigious oncology research unit on the East Coast.  The ideal candidate will be a team player with a unique set of skills:  clinical oncology research experience as well as a BSN/RN.  This individual will have the ability to work closely under MD leadership, as well as have experience supervising clinical research professionals and RNs.  Relocation assistance is available for this position.

 

General Summary



This position reports to the Medical Director of the Cancer Clinical Trials Office (CCTO) and the Director of the Clinical Trials Office (CTO).  The successful candidate will be responsible for development, implementation and oversight of the administrative and operational structure to support all clinical research activity within the CCTO.  This role will support and work closely with the Program Leaders of the CCTO in achieving individual programmatic goals. 

· Supervises all nursing and non-nursing CCTO staff and works closely with senior staff members to plan, prioritize and implement operational goals.

· Ensures that all CCTO staff have clearly defined job descriptions, performance standards, orientation, and continuing education.

· Establish appropriate quality control procedures to ensure compliance with federal, state, local, and institutional guidelines.

· Serves as the primary point of contact internally and externally for cancer clinical trials.

· Assists in preparation and oversight of various clinical research-related grants including associated network institution activities.

 

Principal Responsibilities

 Development and Planning: Coordinates the function of the CCTO through formulating/revising and implementing the overall strategic plan. Serves as a member of various leadership committees .

 Administration:

· Hires, supervises and evaluates Research Nurses, Clinical Research Associates, Clinical Research Coordinators, Clinical Trial Specialist, regulatory staff and support staff and recommends various personnel action including, but not limited to, hiring, performance management, disciplinary action, promotions and transfers.

·  Coordinates work flow and assignments to ensure most efficient and effective use of personnel and resources.

· Chairs Committee responsible for development and implementation of training programs.

· Ensures all CCTO staff complete required orientation and continuing education programs.

· Oversees development and implementation of cancer specific training programs as needed.

· Provides input on the feasibility of conducting new trials, as well as any personnel/logistical conflicts with ongoing trials. 

· Serves as a resource to Research Administrative staff, physicians, nurses, and non-nursing clinical research staff.

· Works with Hematology and Oncology leadership staff to ensure financial stability of individual programs and CCTO general accounts.

 

Quality Assurance and Regulatory Compliance:

· Collaborates with CCTO regulatory office to develop and implement appropriate quality control guidelines.

· Coordinates participation in audits of cancer clinical trials, as well as reviews audit reports.  Will also provide input into audit responses and corrective action plans.

· Coordinates with regulatory office to disseminate information from federal, state, local, and institutional regulatory bodies.

 

Qualifications/Requirements:

1.  BS Degree in nursing and/or oncology based clinical specialty (clinical oncology, pharmacology, oncology nursing).  Master's Degree preferred.

 

2.  4-6 years of clinical research experience, preferably with a focus in Oncology or other high-risk research specialty with proven competence in investigator initiated, industry, cooperative group sponsored research.

 

3.  3 plus years of personnel management experience, with demonstrated ability to effectively manage a large and diverse staff.

 

4.Must demonstrate strong understanding of policy and practice governing research compliance within a large institution, and possess the ability to operationalize evolving research policy (IRB, FDA, OHRP, DHHS) relating to human subjects research.

 

5.  Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel.

 

6. A high degree of flexibility and adaptability is necessary.