Clinical Research Consent Writer - GU & GI Oncology
Dana-Farber Cancer Institute
Location: Brookline, Massachusetts
Internal Number: 2023-33276
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
The Clinical Research Consent Writer is responsible for overseeing the authoring, development and overall quality assurance of the disease group???s consent documents submitted as part of the New Protocol Applications and any required consent amendments. This position will be the primary point person responsible for the collaboration / navigation with the DFCI IRB contacts, clinical trial sponsors, DFCI designated Principal Investigator and the disease group Clinical Research Manager to facilitate and streamline consent development within established timelines. ??
PRIMARY DUTIES AND RESPONSIBILITIES:
Prepare informed in consent documents for the CCTI research program in accordance with DF/HCC local policy and Federal regulatory requirements.
Manage established timeline benchmarks, monitor progress and keep all key stakeholders informed ongoing.
Collaborate across DFCI and DF/HCC departments to expedite and or navigate resolving complex problems or issues causing barriers to consent approval.
Prepare study-specific informed consent documents using established DF/HCC templates, information from the protocol, other study specific documents, consent libraries and glossaries, required risk language, along with any other databases and online resources such, as the NCI/CTEP website.
Meet regularly with disease center leader, program & regulatory manager to review and collaborate regarding workload prioritization.
Liaison with key DFCI IRB, DF/HCC departments, industry sponsors, government and other clinical trial funding sources to work toward establishing consistent, agreed upon consent language.
Read and understand protocol-specific design
??At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.?? As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.?? Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we.??If working in this kind of organization inspires you, we encourage you to apply.
MINIMUM JOB QUALIFICATIONS:
Bachelor???s degree in Biology, Life Sciences, or related field.
2 years??? experience in clinical research and regulatory coordination. Medical writing experience preferred.
Experience in an academic institution is preferred
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Proficient knowledge of regulatory affairs, research ethics and the responsible conduct of research.
Strong ability to work independently and balance multiple projects and tasks simultaneously.
Ability to lead multiple projects simultaneously.
Strong ability to both work as a member of and effectively and proactively collaborate with multiple teams.
Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities using established guidelines and governmental regulations in a clear, concise and health-literate format.
Essential attention to detail, organizational, communication, and interpersonal skills.
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.
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 under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.