Regulatory Coordinator - Lymphoma

Dana-Farber Cancer Institute is hiring a Regulatory Coordinator to coordinate regulatory requirements and clinical trial activities for Lymphoma department research projects. The role prepares and submits regulatory documents, maintains study records and tracking systems, supports study start-up and monitoring, and coordinates with study teams, sponsors, and regulatory offices to ensure compliance.

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), Office of Biotechnology Activities (OBA), etc
• Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC 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, DF/HCC ODQ, 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
• Responsible for data entry of Subject Visit Tracking information (as applicable for role) into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information
• Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed
• 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 Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
• Present regulatory status for disease group portfolio at applicable research meetings

Preferred

• 0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred, along with a basic understanding of clinical trial conduct
• 0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred, along with a basic understanding of clinical trial conduct.
• Medical business experience
• Scientific research experience
• Technology business experience
• Clinical trial conduct knowledge

Benefits

• Fully remote work with occasional time on-campus in Boston, MA; remote work is limited to a New England state (ME, VT, NH, MA, CT, RI).

Company

• Cancer treatment and research institute for children and adults
• Boston, Massachusetts, USA
• http://www.dana-farber.org/
• Founded in 1947
• 1001-5000 employees

Qualifications

• 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
• Requires experience with medical terminology
• The position requires a bachelor's degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator
• 0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred, along with a basic understanding of clinical trial conduct
• The position requires a bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator.

Required skills

• ICH/GCP, FDA Regulations and Guidance, IRB Submission and Approval Process, Clinical Trial Conduct, Regulatory Binder Maintenance, FDA IND Submissions, Protocol and Informed Consent Development, Medical Terminology

Preferred skills

• Written and Oral Communication

Experience

• Entry level