Clinical Trials Monitor - Transplant Clinical Trials

Company: Dana-Farber Cancer Institute
Location: Boston
Posted on: January 15, 2021

Job Description:

The Clinical Research Specialist performs, coordinates, and monitors all aspects of the regulatory process within clinical trials in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. Responsible for multiple projects and must work both independently and in a team environment. May participate in protocol and study development and start up processes including reviewing protocols, designing and/or reviewing Case Report Forms, preparing informed consent documents, developing study specific source document worksheets, and working with study team management on operational strategies.* Assist in the development and writing of clinical trial protocols.* Liaise with investigators and disease groups on conducting clinical trials.* Prepare and manage regulatory applications to federal and local agencies (FDA, OHRS, etc.) and the related approval process.* Locate and/or assess the suitability of study sites to conduct clinical trials.* Monitor trial progress throughout its duration which may include visiting study sites on a regular basis.* Verify that data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).* Act as a regulatory resource for study sites by maintaining regular contact with investigators and study teams during the course of studies to ensure that compliance is maintained.* Prepare reports as required regarding the status of ongoing studies and make necessary recommendations for contingency planning.* BS/BA degree required; Master's preferred. * Minimum of 5 years clinical research experience with oncology background preferred.* Requires excellent verbal and written communication skills with an in-depth knowledge of GCP guidelines, medical terminology, and the clinical trial process. * In addition, excellent interpersonal skills with strong organizational skills and an attention to detail are needed. * Must be computer literate and be able to travel depending on project needs.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.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.

Keywords: Dana-Farber Cancer Institute, Boston , Clinical Trials Monitor - Transplant Clinical Trials, Other , Boston, Massachusetts