Clinical Research Activation Coordinator II

Mass General Brigham; Boston (MA); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading healthcare organization in Massachusetts seeks a regulatory affairs professional to ensure compliance with clinical research regulations. The role involves preparing and maintaining accurate regulatory documents and liaising with various stakeholders. Required qualifications include a Bachelor's Degree in Healthcare Management and regulatory experience, with a focus on strong organizational and communication skills. Remote work flexibility is offered.

Benefits

Salary up to $34.81/hour

Comprehensive benefits package

Opportunity for career advancement

Qualifications

• 2-3 years of regulatory affairs experience required.
• Familiarity with Good Clinical Practice (GCP) guidelines.
• Strong organizational skills with attention to detail.

Responsibilities

• Monitor compliance with applicable regulations.
• Prepare and submit regulatory documentation for clinical trials.
• Act as a liaison between research team and regulatory authorities.

Skills

Regulatory Compliance

Organizational Skills

Communication Skills

Education

Bachelor's Degree in Healthcare Management

Tools

Regulatory Documentation Software

Job description

Employer Industry: Healthcare Research

Why consider this job opportunity:

• Salary up to $34.81/hour
• Opportunity for career advancement and professional growth within the organization
• Comprehensive benefits package, including recognition programs
• Remote work flexibility, allowing you to work from anywhere
• Chance to be part of a mission-driven organization focused on patient care and research

What to Expect (Job Responsibilities):

• Monitor and maintain compliance with applicable regulations and institutional policies related to clinical research
• Prepare, review, and submit regulatory documentation necessary for clinical trials
• Facilitate the submission of study protocols and related documents to the Institutional Review Board (IRB)
• Maintain accurate regulatory documentation, including informed consent forms and safety reports
• Act as a liaison between the research team, principal investigators, sponsors, and regulatory authorities

What is Required (Qualifications):

• Bachelor's Degree in Healthcare Management or a related field required
• 2-3 years of regulatory affairs experience required
• Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations
• Strong organizational skills with attention to detail and ability to manage multiple projects
• Excellent written and verbal communication skills

How to Stand Out (Preferred Qualifications):

• Proficiency in using relevant software and electronic systems for regulatory documentation management
• Understanding of the clinical trial process and importance of regulatory compliance

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