Clinical Research Coordinator - Breast Oncology Cohort Studies Research Program

Job Details

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Job ID:
25365

Location:
450 Brookline Ave, Boston, MA 02215

Category:
Clinical Research

Employment Type:
Full time

Work Location:
Onsite:Up to 1 day remote/wk

Overview

The Clinical Research Coordinator will focus on the regulatory affairs for Cohort and Translational Research within the Cohort Studies Research Program in the Department of Breast Oncology. This unique position will focus on the regulatory activities for our departmental cohort studies' protocols and specific translational studies using clinical data and biospecimens, while gaining exposure to the essential policies and processes needed to facilitate research, specifically in the context of investigator-initiated studies. Responsibilities include drafting, writing, submitting, coordinating new protocols, consents, amendments and institutional agreements (Material Transfer Agreement, Data User Agreement) to ensure conformance with all applicable regulations and policies. In addition, the Clinical Research Coordinator will assist in facilitating and coordinating the approval process of investigator-led studies to access our departmental clinical data and biospecimens via the DF/HCC Breast Users' Committee. The Clinical Research Coordinator will work with close direction of the Principal Investigators, Associate Director, Research Project Managers of cohort studies, as well as Managers and Directors of our biospecimen repository. The CRC will have direct exposure to the behind-the-scenes work of designing translational studies with clinical data and biospecimens.

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.

Requirements

This position may be responsible for some or all of the following:

  • Work on the regulatory matters related to our departmental cohort studies' protocols and specific translational studies using clinical data and biospecimens.
  • Assists PI and Associate Director of Cohort Studies with protocol and consent form development, drafting, and submission for initial application and subsequent amendment changes for departmental cohort/banking studies and investigator-led research. 
  • Lead and track the submissions of new studies and amendments into iRIS, our platform for protocol submissions. Coordinate the feedback and response based on conditions provided related to submissions in a timely manner in collaboration with the PI and managers.
  • Monitor the portfolio of studies under the Cohort Studies Research Program to track annual continuing review for OHRS and DF/HCC User Committees. Work closely to alert relevant principal investigators.
  • Review and update the membership of study teams in OnCore and iRIS with turnover and MD, provider and staff additions over time.
  • Maintain corresponding regulatory folders with the departmental cohort studies' protocols and specific translational studies.
  • Assist with the submission and approval process of research proposals requesting access to data and biospecimens under the purview of the DF/HCC Breast Users Committee. 
  • May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.
  • May assist with cross-coverage of studies in approaching and consenting patients as well as maintaining sample collection within our Cohort Studies team.

Qualifications

  • Bachelor's Degree required, with 0-1 years of related experience preferred. Experience working in a medical or scientific research setting preferred.
  • Excellent organization and communications skills required.
  • Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts.
  • Must be detail oriented and have the ability to follow-through.
  • Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times.
  • Must have computer skills including the use of Microsoft Office

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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