Clinical Research Regulatory Coordinator

BMC Software • Boston, MA

1d • Onsite

About The Position

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 fulfilment of regulatory compliance within CHCRP.

Requirements

• Bachelor's degree (BA, BS) in life sciences, nursing, or other related discipline is required.
• Good Clinical Practices (GCP) Certificate
• Human Subject Protection (HSP) Certificate
• 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.
• 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.

Responsibilities

• 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.
• 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.
• 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
• 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.

Benefits

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• 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.
• Engage in groundbreaking research projects that are driving the forefront of biomedical science.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level