Regulatory Coordinator - Breast Oncology

About the role

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Breast Oncology clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.

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
• Affords assistance 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
• Tracks and manages assigned new protocol start-up packet; initiates, facilitates, and monitors study start-up progress to ensure established benchmarks are met
• Communicates and collaborates with clinical trial key stakeholders through the start-up process, provides regular updates and ensures all start-up activities are completed
• Creates and maintains 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. Ensures various regulatory reporting required are met, Study Sponsor, FDA, IRB etc.
• Establishes and maintains 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
• Serves as facilitator for study team and sponsor regarding 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
• Affords assistance to Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
• Presents regulatory status for disease group portfolio at applicable research meetings

Requirements

• 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
• Requires demonstrated organization and time management/prioritization skills with the ability to work independently
• Must be proficient in the use of computers, Microsoft applications and databases
• Requires experience with medical terminology

Qualifications

• The position requires a bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator. Additionally, 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.

Skills

• Excellent written and oral communication skills
• Maintain confidentiality of information
• Demonstrate good decision-making and judgment
• Have attention to detail and follow-through skills
• Proficient in the use of computers, Microsoft applications and databases
• Experience with medical terminology

Benefits

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Pay

$55,530.00 - $61,700.00

Schedule

Remote: occasional onsite