Regulatory Affairs Specialist - 242975 Job at Medix™, Springfield, MA

ZFN1a2dyNGhGZEFSQWdQN0E2VUh5VUxm
  • Medix™
  • Springfield, MA

Job Description

Regulatory Affairs Specialist

Full Time - 40 hours a week

ONSITE - Springfield, MA, US

Summary: The Regulatory Affairs Specialist (Level 2) independently manages regulatory submissions, communications, and documentation across multiple studies at clinical research sites. This mid-level position requires an in-depth understanding of FDA, ICH-GCP, HIPAA and IRB requirements as well as proficiency in regulatory software tools and CTMS.

  • Prepares and submits regulatory documents to IRBs and sponsors independently.
  • Maintains regulatory binders electronically and in the CTMS in compliance with regulations governing clinical research GCP and site SOPs.
  • Drafts and revises ICFs, site-specific regulatory forms, and other regulatory documents.
  • Coordinates responses to IRB queries and sponsor requests for information.
  • Serves as the primary regulatory point of contact for assigned studies.
  • Participates in internal audits and regulatory reviews.
  • Supports and mentors Regulatory Assistants in task completion and training.
  • Monitors document version control and conduct routine regulatory QC checks.
  • Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required.
  • Performs other miscellaneous job-related duties as assigned by their manager.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

  • Associate or bachelor’s degree required, preferably in life sciences or health-related field.
  • 3–5 years of clinical research regulatory affairs experience.
  • Strong working knowledge of eRegulatory and CTMS platforms and Microsoft Office Suite.
  • Familiarity with 21 CFR, GCP, HIPAA, and IRB regulations.
  • Strong written and verbal communication skills.
  • Certifications such as ACRP-CP, SOCRA CCRP, or RAC preferred.

Continuing Education:

  • GCP (Good Clinical Practice) – Must renew every 3 years
  • OSHA trainings

Physical Requirements and Environmental Factors:

  • Continually required to sit.
  • Continually required to utilize hand and finger dexterity.
  • Continually required to talk or hear.
  • The employee must occasionally lift and/or move up to 10 pounds.
  • Travel is required up to 15% of the time.

Job Tags

Full time,

Similar Jobs

West Valley-Mission Community College District

Part-Time Social Justice Instructor Job at West Valley-Mission Community College District

 ...education format. The assignments are as needed, during Spring, Summer, and/or Fall semesters. This position is represented by the West...  ...APPLICATION INFORMATION: Interested applicants must submit online all materials requested, including: (1) A completed online West... 

CLAE SOLUTIONS

Sales & Account Management Role - Renewable Energy - Join a mission-driven company focused on environmental impact (Hiring Immediately) Job at CLAE SOLUTIONS

Clae Goldman Team is seeking a proactive and results-oriented Field Account Manager to join our team. Our mission is to protect customers from rising energy costs, offer discounts, and promote green energy. As a Field Account Manager, you will be responsible for managing...

My Privia Health

Live Chat/Customer Support Agent Remote Work From Home (Day Shift/Night Shift) Job at My Privia Health

As a Live Chat/Customer Support Agent, you will be responsible for delivering exceptional service to our customers via live chat,...  ...customers have the best possible experience. This is a remote, work-from-home position with flexible day and night shifts.Key... 

ManTech

Principal Security Engineer Job at ManTech

 ...MANTECH seeks a motivated and customer-focused Principal Security Engineer to join our team in Chantilly, VA . In this role, you will help design, implement, and sustain mission-driven network solutions that enable secure enterprise operations. You will provide technical... 

Graced Technology Solutions

eDiscovery Archive and Data Loading specialist Job at Graced Technology Solutions

Job Description Job Description Salary: DOE eDiscovery Data Loading Position Description Responsibilities: Adhere to and actively manage timelines associated with data requests Independently work on job requests from a queue, as well as by assignment, to...