Clinical Research Coordinator - Clinical Trials Office

US-MA-Boston
5 days ago
Job ID
2018-8981
Category
Clinical Research
Type
full time
Grade
18

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 Clinical Research Coordinator work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI Clinical Trials Office. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials. Some travel may be required.

Responsibilities

This position will work with the PROFILE team and primarily be responsible for supporting the disease programs within Medical Oncology in consenting and coordination of tissue banking trials using Good Clinical Practice under the auspices of the Principal Investigator.  The CRC will be responsible for educating new patients seen in the Oncology clinics about, and consenting them to, the tissue banking studies available at DFCI. This individual will be responsible for screening patients for protocol eligibility, obtain informed consent, and register study participants within the CTMS system OnCore. The position will coordinate all aspects of protocol submissions, prepare and submits all regulatory documents, and maintains records on each study to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal and ICH/GCP guidelines.  The CRC will also be responsible for working as part of group to maintain and to update research databases.

  • Evaluating, tracking and consenting of all new patients seen in the HM clinic for inclusion in the study.
  • Prepare and or complete regulatory related reports and IRB submissions.  Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
  • Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
  • Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.
  • Interact with study participants as directed/required by the protocol and/or study team.
  • May be responsible for tissue sample work.

 

Qualifications

  • Bachelor's Degree required, with 0-1 years of related experience preferred. Experience working in a medical or scientific research setting or comparable technology orientated business environment 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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