Job Description

Job Summary

Massachusetts General Hospital and Harvard Medical School are seeking a highly motivated candidate to join the Immunobiology Laboratory. The role focuses on innovative clinical trials for the treatment of type 1 diabetes using the BCG vaccine, with opportunities to gain hands-on experience in regulatory medicine and translational research. Full time, 100% onsite and predominately early morning visits starting at 700AM, M-F. Anticipated working hours are 7AM-4PM.

The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities.

Key Responsibilities

Leadership & Training

• Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices.

Study Coordination

• Provide an extra layer of support in managing studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits.
• Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs.

Regulatory & Compliance

• Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports.
• Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies.
• Assist in coordinating Data Safety Monitoring Board (DSMB) meetings.
• Update and review Standard Operating Procedures (SOPs).

Program Development

• Assist in developing standard operating procedures and quality assurance systems.
• Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions.

Qualifications

Education & Experience

• Bachelor’s degree required (health sciences, psychology, public health, nursing, or related field preferred)
• Minimum of 5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation.

Skills & Competencies

• Ability to oversee, train and evaluate others effectively.
• Strong organizational, time management, and problem-solving skills.
• Excellent interpersonal and written/verbal communication skills.
• Ability to work independently and collaboratively across multiple investigators and teams.
• Familiarity with REDCap and other data capture systems preferred.

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