Clinical Research Coordinator l BWH Allergy

Brigham and Women's Hospital
United States, Massachusetts, Boston
60 Fenwood Road (Show on map)
Jan 01, 2025
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. 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:* B.S. or B.A. At least one year of work experience in clinical research or internship preferred *SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:* Strong organizational and communication skills. Excellent interpersonal skills are required for working with the study participants. Experience in a clinical environment. Strong analytical and computer skills required, proficiency with Microsoft Access, Excel, Word, and Outlook. Proficiency in Research Electronic Data Capture (REDCap) preferred. Effective problem-solving skills. *WORKING CONDITIONS:* Will work in the Brigham and Women's Hospital Main Campus and associated Mastocytosis Center facilities and shared offices offices. Additional work will be at the BWH Mastocytosis Center at the 850 Boylston Street site in Chestnut Hill, MA. The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.