Clinical Research Coordinator

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 RC coordinates all aspects of initial protocol submissions, IRB amendments, prepares and submits regulatory documents, and maintains records in accordance with GCP principles on assigned studies to ensure regulatory compliance with BMC/BU policies as well as federal regulation and ICH/GCP guidelines. This position will work both independently and collaboratively with a variety of personnel at all levels including faculty and study team members of BMC/BU and other external institutions cooperative groups clinical trials experts representatives from the pharmaceutical industry federal agencies and other research organizations. Contributing to a culture of compliance the RC works interactively with CHCRP clinical research staff leadership the Office for Human Research Studies (OHRS) BMC Clinical Trial Office ancillary departments supporting CHCRP clinical trials and is responsible for the proactive initiation and fulfillment of regulatory compliance within CHCRP.

Job Responsibilities

• Regulatory Compliance
• Prepares and submits all protocol applications amendments continuing reviews and informed consent documents for SRC and IRB review and approval.
• Prepares and submits regulatory documentation that may include IND/IDE applications FDA annual reports Serious Adverse Event reports to the appropriate regulatory agencies including the Food and Drug Administration (FDA) etc.
• Prepares maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement Industry sponsor BMC/BU sponsored etc.
• Maintains various regulatory tracking databases with information related to study recruitment subject enrollment and study progress and completion.
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator Investigator BMC/BU stakeholders Industry Sponsors and third party auditors.
• Clinical Trial Management
• Track and manage assigned new protocol start-up packet initiate facilitate and monitor study start-up progress to ensure established benchmarks are met.
• Communicate and collaborate with clinical trial key stakeholders through the start-up process provide regular updates and ensure all start-up activities are completed.
• Create and maintain tracking for all subsequent submissions to the SRC / IRB protocol & consent amendments all required safety reporting all required deviation violation exception or other event reporting. Ensure various regulatory reporting required are met Study Sponsor FDA IRB etc.
• Key Stakeholder Interfacing
• Establishing and maintaining regular communication with study team study sponsor applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable.
• Serve as facilitator for study team and sponsor with regard to study status information critical safety issues upcoming protocol consent and IDB amendments and applicable protocol training responsible for the systematic documentation / tracking when applicable.
• Leadership and Professionalism
• Maintain working knowledge of current regulations regulatory guidance and or local policies.
• Assists Senior Regulatory Manager with regulatory based training and implementation of new or revised regulation guidance and or local policy.
• Present regulatory status to Senior Regulatory Manager for dissemination at disease group research meetings.
• Demonstrates a strong commitment to a culture of compliance by maintaining accurate regulatory documentation proactively addressing potential compliance risks collaborating with study teams to ensure regulatory adherence and participating in audits monitoring and continuous improvement efforts.

Job Requirements

Education: Bachelor's degree (BA BS) in life sciences nursing or other related discipline is required.

Certificates Licenses Registrations Required: Good Clinical Practices (GCP) Certificate Human Subject Protection (HSP) Certificate

Experience: 2-3 years of related research experience or research specific training and education. Fundamental knowledge of the conduct and regulatory management of industry and federally funded interventional clinical trials is required.

Knowledge Skills & Abilities: Must possess excellent written and oral communication skills maintain confidentiality of information demonstrate good decision-making and judgment and have attention to detail and follow-through skills. Demonstrated organization and time management/prioritization skills with the ability to work independently are required. Must be proficient in the use of computers Microsoft applications and databases.

Job Benefits

Competitive pay Tuition reimbursement and tuition remission programs Highly subsidized medical dental and vision insurance options Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research. Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.

About the Department

As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry intellectual rigor shapes our inquiries. Our research is led by a belief that skin color zip code and financial circumstances shouldnt dictate health.

Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability please send an e-mail to View email address on click.appcast.io or call View phone number on click.appcast.io to let us know the nature of your request.

Compensation Range: $53,000- $77,000

This range offers an estimate based on the minimum job qualifications. However our approach to determining base pay is comprehensive and a broad range of factors is considered when making an offer. This includes education experience skills and certifications/licensures as they directly relate to position requirements as well as business/organizational needs internal equity and market-competitiveness. In addition BMCHS offers generous total compensation that includes but is not limited to benefits (medical dental vision pharmacy) discretionary annual bonuses and merit increases Flexible Spending Accounts 403(b) savings matches paid time off career advancement opportunities and resources to support employee and family well-being.

NOTE: This range is based on Boston-area data and is subject to modification based on geographic location.

Equal Opportunity Employer/Disabled/Veterans

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