Clinical Research Associate

5 days ago

Bedford, United States Pragmatic Full time

We're Hiring: In-House Clinical Research Associate (CRA)


Are you ready to take the next step in your clinical research career? Join a cutting-edge organization making a meaningful impact in healthcare innovation We are seeking an In-House Clinical Research Associate (CRA) to play a pivotal role in supporting and managing clinical trials. This is an exciting opportunity for someone who thrives in a fast-paced, collaborative environment and is passionate about advancing clinical research.


Why You Should Join Us

✅ Impactful Work: Contribute to innovative clinical studies that transform patient care.

✅ Dynamic Environment: Collaborate with a supportive team of industry experts and external stakeholders.

✅ Career Growth: Take on diverse responsibilities and gain valuable experience in a forward-thinking organization.


What You’ll Do

As an In-House Clinical Research Associate, you’ll be at the heart of our clinical operations, ensuring trials are executed efficiently and in compliance with regulatory standards. Your responsibilities will include:

  • Investigational Product Management: Oversee the tracking and shipping of investigational products, ensuring accuracy and timely updates.
  • eTMF System Oversight: Maintain and manage the electronic Trial Master File (eTMF) system (experience with Simple Trials or MetaDraze preferred).
  • IRB Coordination: Handle IRB submissions, responses, and approvals to ensure timely regulatory compliance.
  • Study Startup Activities: Prepare and coordinate study startup materials, including feasibility assessments and site documentation.
  • Audit Preparation: Support audit readiness by maintaining accurate trial documents and ensuring compliance with Good Clinical Practice (GCP).
  • Collaboration and Vendor Management: Work closely with internal teams, external vendors, and investigational sites to align on project goals and ensure seamless trial execution.
  • Quality Control: Conduct quality reviews of trial-related documents and processes, identifying and resolving issues proactively.


What We’re Looking For

Education:

  • Bachelor’s degree in life sciences or equivalent training/experience.

Experience:

  • Minimum 2 years in clinical trial support, preferably in a CRO or bio-pharma setting.
  • Familiarity with GCP (Good Clinical Practice), GDP (Good Documentation Practices), and IRB processes.
  • Experience with eTMF systems like Simple Trials or MetaDraze is highly desirable.


Skills:

  • Exceptional organizational skills and attention to detail.
  • Strong communication and collaboration abilities.
  • Ability to thrive in a fast-paced, dynamic environment.


Work Schedule

This is a hybrid role requiring 3 days in-office per week, with the flexibility to work remotely for the remainder of the week.


Apply Now

If you’re ready to bring your skills and expertise to an organization where you can make a real impact, apply today Let’s shape the future of clinical research together.

#ClinicalResearch #CRAJobs #HealthcareInnovation #NowHiring

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