Research Review Manager - Office for Human Research Studies

Location US-MA-Boston
Job Posted Date 1 month ago(2/16/2018 4:04 PM)
Job ID
Clinical Research
full time


Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.


The Office for Human Research Studies (OHRS) is the Dana-Farber Cancer Institute office that oversees the following committees and processes for the Dana-Farber/Harvard Cancer Center (DF/HCC):

  • Scientific Review Committee (SRC)
  • Dana-Farber Cancer Institute (DFCI) Institutional Review Board (IRB)
  • Activation


Scientific Review is a requirement of the NCI Cancer Center Support Grant (CCSG) that funds the DF/HCC.  All cancer-relevant research at DF/HCC member institutions must be reviewed and approved by a SRC or through expedited administrative scientific review for prioritization, as permitted by the CCSG.  The SRC assesses a research protocols scientific merit, prioritization and feasibility of trial completion, as well as the progress of approved research terminating research that no longer meets those criteria.  OHRS manages five SRC panels.


The DFCI Instituional Review Board (IRB) functions as a single IRB of record for the clinical institutions that comprise the DF/HCC.  OHRS manages seven IRB panels.


OHRS also manages Activation - the process where operational requirements to conduct the research are identified and verified as being complete before the research is permitted to begin.  Operational requirements are identified by institutional departments, including, but not limited to:



The Research Review Manager is expected to work independently. This individual must be able to see the high level operational and substantive issues related to SRC, IRB and Activation and devise appropriate management plans. This individual must have solid analytical, oral and writing skills and be able to effectively communicate with senior officials at all of the Harvard clinical institutions that operate under the umbrella of the Dana-Farber/Harvard Cancer Center. The Research Review Manager interacts with research managers at the DF/HCC member institutions.


  • Oversees the provision of reporting metrics to the Director regarding cancer research involving human subjects
  • Serves as a liaison to the clinical trials offices of the five Harvard institutions that comprise the DF/HCC consortium
  • Represents the OHRS at DF/HCC meetings including but not limited to the Standard Operating Procedure Meeting
  • Attends SRC and IRB meetings and ensures regulatory compliance with the regulations / PRMS
  • May act as alternate for the DSMC and audit committee meetings. 
  • Responsible for managing the policies and procedures of OHRS and training new Human Research Coordinators. 
  • Responsible for developing an education program for IRB members
  • Monitors and redistributes HRC protocol workloads as needed
  • Manages the AAHRPP accreditation for the DFCI IRB acting on behalf of the DF/HCC
  • Responsible for managing the Scientific Review Process and Accrual Monitoring as required by the PRMS.
  • Serves as a liaison to the clinical trials offices of the five Harvard institutions that comprise the DF/HCC consortium
  • Represents the OHRS at DF/HCC meetings including but not limited to Clinical Research Operations and Standard Operating Procedure Meetings
  • Responsible for ensuring OHRS research records meet regulatory and scientific review requirements and that office processes are consistent and efficient.      
  • Responsible for managing and training Human Research Coordinators on Regulatory Compliance. 
  • Responsible for developing an education program for SRC members
  • Assist the Senior Human Research Coordinator(s) by carrying a small research protocol load when needed.
  • Monitors and redistributes HRC workloads as needed
  • Front End OHRS Systems management working closely with the OHRS Operations Manager. Systems include, but not limited to: P360, OnCore and LiveLink.
  • Research Review Management of Scientific Reviews, IRB Reviews and Activation Processes.
  • Assists with other projects as directed by the Director / Associate Director of OHRS



  • BS / BA required; advanced degree preferred.
  • Certified IRB Professional (CIP) preferred
  • 5 years of experience in a Cancer Center and/or working with an Institutional Review Board (IRB).
  • Strong understanding of the Common Role. Familiarty with pending Common Role changes.
  • Familiarity with the NIH Single IRB rule, and the impact on IRB offices.
  • Minimum of 2 years of supervisory experience required.



  • Knowledge of Federal, state, and local regulatory information regarding the protection of human subjects in biomedical and behavioral research
  • Understanding of/or ability to learn procedures integral to scientific review
  • Strong communication skills necessary to allow productive communication between OHRS and investigators and other research personnel
  • Problem solving, decision-making and analytical skills necessary to identify problems and proposed solutions and the ability to implement solutions
  • Must have demonstrated ability to manage multiple priorities and responsibilities. 
  • Demonstrated ability to manage people
  • Ability to work within a team setting and foster collaboration
  • Excellent customer service skills
  • Ability to accurately and concisely disseminate information in both written and verbal formats to diverse audiences
  • High degree of flexibility and adaptability in order to manage change
  • Ability to solve problems independently and know when to escalate to OHRS senior staff
  • Excellent interpersonal and negotiation skills
  • Demonstrated ability to use independent judgment in making decisions
  • Ability to prioritize and manage multiple competing priorities
  • Ability to work independently and cooperatively
  • Flexibility and motivation to work on special projects relating to the mission of OHRS as directed by the Director / Associate Director


Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.



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