Regulatory Coordinator - Neely Center for Clinical Cancer Research

About the Role

This role focuses on managing operational aspects of ongoing projects from initiation through completion and serves as a liaison between project management and planning, project team, and line management. The position works under the direction of the Principal Investigator(s), Research Director, and Clinical Research Regulatory Project Manager to complete the regulatory requirements of clinical research projects.

Assists with coordinating aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with Tufts Medical Center policies as well as federal regulations and ICH/GCP guidelines. Works collaboratively with personnel at all levels, including faculty, study team members, external institutions, cooperative groups, clinical trials experts, pharmaceutical industry representatives, federal agencies, and other research organizations.

Responsibilities

• Assists with tracking and managing new protocols in start-up; initiates, facilitates, and monitors study start-up progress to ensure established benchmarks are met.
• Responsible for Institutional Review Board (IRB) requirements for each study, including meeting institutional educational requirements and submitting documents for review.
• Creates and maintains tracking for all subsequent SRC/IRB submissions, protocol and consent amendments, safety reporting, deviation, violation, or other event reporting.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location.
• Reviews existing protocols, prepares approval submissions, files regulatory documents, implements improvements, and follows regulations regarding research, assessment, and data gathering accurately.
• Collaborates with research coordinators, regulatory project manager, principal investigators, and other departments with the submission of protocol amendments and other regulatory submissions.
• Establishes and maintains regular communication with study team, study sponsor, and applicable regulatory agencies/offices to ensure all required information is relayed; responsible for systematic documentation/tracking when applicable.
• Ensures various regulatory reporting requirements are met and adheres to FDA Good Clinical Practice (GCP) guidelines.

Requirements

• Bachelor’s Degree (required).
• One (1) year of research-related experience (preferred).
• CITI Human Research Protection Certification (preferred).
• Previous regulatory/IRB submission experience (desired).

Skills & Abilities

• High degree of organizational talent and data collection/analysis skills.
• Meticulous attention to detail.
• Excellent computer skills, including word processing.
• Ability to prioritize quickly and appropriately.
• Excellent communication and interpersonal skills.
• Maintains working knowledge of current regulations, regulatory guidance, and/or local policies.

Physical Requirements

This is largely a sedentary role involving sitting most of the time but may require walking, standing, reaching, ascending/descending stairs, and operating office equipment. Frequently required to speak, hear, communicate, and exchange information. Ability to see and read computer displays, fine print, and normal type size, and distinguish letters, numbers, and symbols. Requires manual dexterity using fine hand manipulation to operate a computer keyboard.

Pay

The base pay range for this role is $21.53 - $26.91 per hour. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity.