Posted in Other about 20 hours ago.
Site: The Brigham and Women's Hospital, Inc.
At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.
At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.
Job Summary
The Clinical Research Coordinator will be directly supervised by Drs. Castells and Giannetti. The coordinator develops, executes, and oversees work on several clinical trials involving patients with systemic microcytosis and other mast cell activation related disorders. The RAI will be responsible for screening, enrolling, and following subjects through the trials, managing the administrative aspects of this trial, and monitoring the studies/ progress to assure data quality and adherence to protocols as well as timelines. The position requires a detail-oriented individual with an ability to understand complex protocols and become certified for procedures such as phlebotomy, electrocardiogram (ECG), and related challenges.
Qualifications
The principal duties and responsibilities (specific clinical techniques below will be taught, and previous expertise in these areas is not required):
Contributes to protocol authorship and plans for the implementation of the specified procedures for research studies evaluating microcytosis treatments, medications and drug desensitization. May draft clinical research forms (CRFs) and build or maintain databases.
Actively responsible for the recruitment of study subjects. This includes development and implementation of recruitment strategies, telephone screening of potential subjects, enlisting participation by scheduling appointments and sending out necessary paperwork.
Performing study visits, including the administration of consent, phlebotomy, sample processing in the lab, following procedures for study visits, and appropriate follow-up with subjects.
Collects and reviews study data, ensuring compliance with protocol and data integrity. Drafts corrective action plans for any issues identified through quality control. Ensures queries are responded to in a timely manner.
Assists investigators in overseeing regulatory aspects of trials, including monitoring, safety, and protocol deviation documentation as appropriate. Develops and prepares content for study IRB/IND amendments and reports. Ensures audit-ready files are kept.
Serves as the primary contact for assigned project for both internal and external communications. Directly responds to inquiries regarding study protocol and policy.
Prepares and presents regular and ad-hoc study progress reports for weekly meetings, departmental managers, and study sponsors.
Participates in the Bio Bank and tissue repository obtaining patients consent and materials, including blood and tissue samples.
All other duties as assigned.
QUALIFICATIONS:
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