The CRC I will be directly supervised by Drs. Castells and Giannetti. The CRC I develops, executes, and oversees work on several clinical trials involving patients with systemic mastocytosis and mast cell activation related disorders and drug desensitization. The CRC I 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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Contributes to protocol authorship and plans for the implementation of the specified procedures for research studies evaluating mastocytosis treatments, medications and drug desensitization. May draft clinical research forms (CRFs) and build or maintain databases.
2. 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.
3. 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.
4. 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.
5. 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.
6. Serves as the primary contact for assigned project for both internal and external communications. Directly responds to inquiries regarding study protocol and policy.
7. Prepares and presents regular and ad-hoc study progress reports for weekly meetings, departmental managers, and study sponsors.
8. All other duties as assigned.

• B.S. or B.A.
• At least one year of work experience in clinical research or internship preferred

• 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.

BWH is an Affirmative Action Employer. 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.