Human Research Coordinator IV

US-MA-Boston
5 days ago
Job ID
2018-9088
Category
Clinical Research
Type
full time
Grade
22

Overview

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 Human Research Coordinator is key to the process for the review and approval of research studies involving human subjects. These positions are located within the Office for Human Research Studies (OHRS) which is responsible for scientific and IRB review of all oncology research undertaken under the umbrella of the Dana-Farber/Harvard Cancer Center.

 

 

Responsibilities

The Human Research Coordinator IV (HRC IV) is responsible for having the knowledge and ability to conduct regulatory activities pertaining to the review of initial submissions, continuing reviews and amendments submitted to external IRBs.  During the lifecycle of the study, the HRC IV is responsible for ongoing reviews to assure the integrity of the submissions, study files, and federal grants, for agreement with regulations and institutional policies. Primary point of contact and source guidance for single IRB review and reliance/master agreements.

 

  • Maintains advanced knowledge of federal regulatory requirements, OHRS operating procedures and DF/HCC policies and procedures.
  • Acts as liaison between the external IRBs and researchers, serving as a primary point of contact and subject matter expert on the regulations that govern the conduct of research with human subjects.  
  • Conducts independent, in-depth reviews focusing on institutional and regulatory compliance, assuring the protocol and informed consent are consistent with each other taking into consideration all modifications made to the study to date.
  • Evaluates the risk/benefit ratio and informed consents for institutional and federal regulatory compliance. 
  • Conducts quality assurance audits to ensure the integrity of all protocol files.
  • Provides technical and administrative review of human research application materials prior to review to the convened IRB.
  • Manages the process of submitting amendments and continuing reviews to the convened IRB.
  • Advise and provide consultative services to researchers and research staff to facilitate use of IRB authorization agreements.
  • Responsible for analytical and administrative review and approval of studies being considered for reliance/single IRB requests.
  • Prepare, negotiate, coordinate and track IRB review and documentation pertinent to the use of IRB reliance/master agreements for situations when DF/HCC relies on an IRB at another institution.
  • Develop policies, procedures, Standard Operating Procedures (SOPs), practices and forms to facilitate and streamline the reliance /master agreement review process. 
  • Develop and implement training/educational materials for the research community (e.g. how to submit), as well as training and education for staff on how to review and process protocols covered by an authorization agreement.
  • Oversee and participate in monitoring activities to assure all regulatory and compliance requirements are being met and to make sure agreements are being followed as approved.
  • Performs all other duties as assigned

 

 

Qualifications

  • Bachelors degree required.  

  • A minimum of three (3) to five (5) years in IRB / Research Compliance related experience (beyond entry level), clinical research or regulatory setting required.

  • Certified IRB Profession (CIP) preferred. 

  • Experience working in a scientific research setting or comparable technology-oriented business. 

  • Excellent English language reading, writing, and speaking skills required

Competencies: 

  • Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals.
  • Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
  • Attention to Detail: Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
  • Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
  • Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
  • Managing Work and Time/Project Management: Effectively managing one's time and resources to ensure that work is completed efficiently. Effectively manages project(s) by appropriately focusing attention on the critical few priorities; effectively creates and executes against project timelines based on priorities, resource availability, and other project requirements (i.e., budget); effectively evaluates planned approaches, determines feasibility, and makes adjustments when needed.
  • Problem Solving: Uses issue identification, data relation and comparison, pattern recognition and information gathering to create analyses and make recommendations.
  • Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.


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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