Regulatory Coordinator - Neely Center for Clinical Cancer Research

Tufts Medicine; Boston (MA); On-site; USD 30,000 - 37,000; Full time

Job summary

Tufts Medicine is seeking a Regulatory/IRB Coordinator to support the coordination of regulatory submissions and ensure compliance with Tufts Medical Center policies, FDA regulations and ICH/GCP guidelines. You will work with faculty, investigators and cross-functional teams in NCCCR under the direction of principal investigators and regulatory managers.

The role involves tracking, document management, and timely reporting of protocol amendments, safety events, and deviations, with an emphasis

Qualifications

• Bachelor's Degree.
• One year of research related experience.
• CITI Human Research Protection Certification.
• Previous regulatory/IRB submission experience is desired

Responsibilities

• Assist with coordinating startup of new protocols and monitor start-up progress.
• Handle IRB requirements for each study and submit required documents.
• Create and maintain tracking for protocol amendments, consent forms, safety reporting and deviations.
• Maintain patient confidentiality and secure study records.
• Review protocols, prepare approval submissions, file regulatory documents and follow regulations.
• Collaborate with study team, regulatory project manager and investigators on submissions.
• Maintain regular communication with study team, sponsor and regulatory offices for timely information.
• Ensure regulatory reporting requirements are met.
• Adhere to FDA Good Clinical Practice guidelines.

Skills

Organizational skills

Data analysis

Attention to detail

Word processing

Prioritization

Communication

Regulatory knowledge

Education

Bachelor's Degree

Job description

Job Profile Summary

This role focuses on managing operational aspects of ongoing projects from initiation through completion and serves as liaison between project management and planning, project team, and line management. In addition, this role focuses on performing the following Administration Project Management duties: Serves as a liaison between the general project management office and the team members engaging in planning, reviews the status of projects and budgets, manages schedules, prepares status reports, and assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.

Job Overview

This position works under the direction of the Principal Investigator(s), Research Director, and Clinical Research Regulatory Project Manager to complete the regulatory requirements of the clinical research project. 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 regulation and ICH/GCP guidelines. Works collaboratively with a variety of personnel at all levels, including faculty and study team members of the Neely Center for Cancer Clinical Research (NCCCR) and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations.

Job Description

Minimum Qualifications:

1. Bachelor's Degree.

Preferred Qualifications:

1. One (1) year of research related experience.
2. CITI Human Research Protection Certification.
3. Previous regulatory/IRB submission experience is desired

Duties and Responsibilities:

The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. Assists with tracking and managing new protocols in start-up; initiates, facilitates, and monitors study start-up progress to ensure established benchmarks are met.
2. Responsible for Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements and submitting documents for review.
3. Creates and maintains tracking for all subsequent SRC/IRB submissions, protocol and consent amendments, safety reporting, deviation, violation or other event reporting.
4. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location.
5. Reviews existing protocols, taking time to prepare approval submissions, filing regulatory documents, implement improvements as needed, and follow regulations regarding research, assessment, and data gathering accurately.
6. Collaborates with research coordinators, regulatory project manager, principal investigators, and other departments with the submission of protocol amendments and other regulatory submissions.
7. 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.
8. Ensures various regulatory reporting requirements are met.
9. Adheres to FDA Good Clinical Practice (GCP) guidelines.

Physical Requirements:

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

Skills & Abilities:

1. High degree of organizational talents data collection and analysis skills.
2. Requires meticulous attention to detail.
3. Excellent computer skills including word processing.
4. Ability to prioritize quickly and appropriately.
5. Excellent communication and interpersonal skills.
6. Maintains working knowledge of current regulations, regulatory guidance and or local policies.

At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.

The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.

Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth - one of the many ways we invest in you so you can thrive both at work and outside of it.

Pay Range:

$21.53 - $26.91