Clinical Research Regulatory Coordinator

Position: Clinical Research Regulatory Coordinator, Cancer & Hematology Clinical Research Program. Location: Boston, MA. Schedule: 40 hours per week. Position Summary The Research Coordinator (RC) is responsible for coordinating all aspects of initial protocol submissions, IRB amendments, regulatory documentation, and record maintenance in accordance with GCP principles and BMC/BU policies. The RC works independently and collaboratively with faculty, study teams, sponsors, regulatory agencies, and external partners to ensure regulatory compliance for assigned studies. Job Responsibilities Regulatory Compliance: prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents; submits IND/IDE, FDA reports, Serious Adverse Event reports; maintains regulatory files and tracking databases; assists in monitoring visits and ensures regulatory reporting to FDA, IRB, and study sponsors. Clinical Trial Management: tracks and manages new protocol start‑up packets, facilitates start‑up progress, communicates with stakeholders, maintains tracking for subsequent submissions, and ensures safety reporting and deviation documentation. Key Stakeholder Interfacing: maintains communication with study team, sponsors, and regulatory agencies; facilitates status updates, safety issues, and protocol amendments; documents and tracks all actions. Leadership and Professionalism: maintains up‑to‑date knowledge of regulations and policies; assists Senior Regulatory Manager with training and implementation of new guidance; presents regulatory status at meetings; demonstrates a commitment to compliance via audits, monitoring, and continuous improvement. Job Requirements Education: Bachelor’s degree (BA, BS) in life sciences, nursing, or related discipline. Certificates/Licenses: Good Clinical Practices (GCP) Certificate; Human Subject Protection (HSP) Certificate. Experience: 2‑3 years of related research experience or training; fundamental knowledge of industry and federally funded interventional trials. Knowledge, Skills & Abilities: Excellent written and oral communication; confidentiality; sound decision‑making and judgment; attention to detail; strong organization, time management, and prioritization; ability to work independently; proficiency in Microsoft applications and databases. Job Benefits Competitive pay ($53,000–$77,000) Tuition reimbursement and tuition remission programs Highly subsidized medical, dental, and vision insurance options Career advancement and professional development opportunities Engagement in groundbreaking research projects Equal Opportunity Statement Boston Medical Center is an equal employment/affirmative action employer and provides equal employment opportunities for all, ensuring no discrimination on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or expression. #J-18808-Ljbffr