Cancer Center Jobs

Protocol Review and Monitoring System Manager

Case Comprehensive Cancer Center

June 24, 2022
Protocol Review and Monitoring System Manager (Specialist 1)
Case Comprehensive Cancer Center

Supervisor Name and Title:    Kevin Hoy, PhD, Administrative Director, Clinical Research Office, Case Comprehensive Cancer Center

Job ID 10217 - APPLY HERE

POSITION OBJECTIVE

This position manages the daily activities of Protocol Review and Monitoring System (PRMS). The person in this position will support the Chairpersons of the Protocol Review and Monitoring Committee (PRMC) in ensuring that the PRMC carries out its scientific review functions efficiently and effectively. This position reports directly to the Administrative Director, of the Case Comprehensive Cancer Center Clinical Research Office (Case CCC CRO). 

The PRMS Manager must be highly competent and innovative in order to enhance the Protocol Review and Monitoring System and its processes to make them more efficient and effective and to be able to work as a team member to accomplish institutional goals. He/she must be able to communicate and work well with research community including clinical researchers and research staff providing high quality service and maintaining the highest standards of protocol review and post protocol review monitoring and oversight. 

ESSENTIAL FUNCTIONS

A. Oversee and manage the daily activities of the Protocol Review and Monitoring System. (50%)

Manage and be responsible for all activities of the Protocol Review and 
Monitoring Committee. In consultation with the Administrative Director, manage 
and coordinate procedures and engineering of office workflow. Prepare meeting 
agendas, assign reviewers and prepare meeting minutes. Prepare PRMC approval 
letters. Coordinate PRMS activities with Case CCC member institutions (Case Western Reserve University, University Hospitals and Cleveland Clinic).
Work with the Chair and Co-chair of the PRMC to oversee implementation of all clinical trial protocols involving cancer patients within the Case CCC.
Design and develop innovative information technology applications to enhance 
efficiency of research and protocol review activities.
Design and develop customized PRMS and other reports.
Serve as a resource for physicians, faculty and staff with respect to PRMS 
requirements.
Assist clinical investigators with the development and submission of a complete protocol and consent form following the Case CCC protocol templates format.
Write and revise policies and standard operating procedures related to PRMS operations.  Maintain information on polices, standard operating procedures and process for the PRMS.
Develop and revise PRMC-related forms and documents. 
Ensure that all the activation steps, including disease team signoff, are completed for all protocols, and that all reviews are completed prior to the presentation of the protocol at the PRMC meeting.
After the PRMC protocol approval, incorporate the recommendations of the committee and the clinical trials disease teams into the Case CCC priority score.
Inform the study team of the final PRMC action.
Coordinate and report on accrual monitoring functions.
Coordinate and report on priority scoring functions.
Maintain PRMC-related information in the in the Cancer Center Clinicial Trials Management System (OnCore™) and perform quality control and quality assurance activities on OnCore data.
Work with the Case CCC webmaster to update and maintain PRMC website.
Maintain all PRMS-related records in compliance with NCI Guidelines.


B. Participate in the Case Comprehensive Cancer Center Clinical Research Office Quality Control and Assurance activities. Serve as a quality assurance officer. (30%)

Monitor information in Oncore on a regularly scheduled basis for quality, completeness and accuracy of data.
Conduct routine quality assurance reviews on data entered into OnCore. 
Identify problems and trends, follow-up with research community and prepare appropriate responses.

 

C. Assist in developing new protocol templates and other study-related documents. Assist, as needed, in developing investigator-initiated studies. (5%)

 

D.  Work with Disease Team Leaders and manage PRMC and the protocol review activities as they relate to Disease Teams operations. (5%)

 

E. Participate and assist in activities related to filing Annual Progress Reports and Cancer Center Support Grant renewals. (10%)


NONESSENTIAL FUNCTIONS

Other duties: as assigned. 

CONTACTS

Department:

University: administrators, faculty, researchers, departmental personnel involved in research;

Hospitals: administrators, physicians, nurses, clinical trials units, departmental personnel involved in research. 

External: National Cancer Institute, Food and Drug Administration, ClinicalTrials.gov, pharmaceutical sponsors and monitors, national and international cancer research cooperative groups i.e. Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, SWOG Cancer Network, Children’s Oncology Group, National Clinical Trials Network

 
SUPERVISORY RESPONSIBILITY

None

QUALIFICATIONS

Experience: Five to eight years of experience in a research environment. Experience in research administration/regulatory document preparation highly preferred. 

B. Education — B.A. required. Master’s degree preferred. 

C. Essential Skills —

Possess excellent interpersonal, communication and writing skills.
Possess effective organizing and planning skills.
Ability to give high attention to detail.
Ability to take initiative and produce results in a dynamic and fast paced environment.
Ability to work efficiently and effectively under sometimes very stressful conditions.
Ability to assume a sense of personal accountability and responsibility for understanding priorities, meeting deadlines, managing and completing multiple tasks.
Self-motivated and able to prioritize workload.
Possess significantly high computer skills and ability to learn new programs. Knowledge of databases required. Possess superior understanding of information systems and their capacity to facilitate workflow and communication as it relates to the activities within the research-oriented environment. Outstanding knowledge of web communication. Able to effectively use electronic document technologies.
Experience in an academic research environment is important, with an understanding of and comfort with the academic medical enterprise and the culture of academic medical centers.
Possess excellent judgment, with a high level of creativity, flexibility, and tact in dealing with colleagues.
Ability to work cooperatively and effectively with diverse constituencies.
Ability to handle confidential material with strict adherence to federal and office policies.
Ability to develop and maintain exceptional relationships with physicians, faculty and staff.
Possess well-developed problem solving skills and the ability to analyze problems and develop creative solutions

WORKING CONDITIONS

Office environment; no chemical exposure.