Job Description
Hi
Greetings from IT Engagements
IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.
Job Title: Clinical Research Associate (CRA) – Medical Device (Neuro / Brain Surgery)
Location: Remote
Employment Type: Contract (W2 / C2C)
Schedule: Part-Time / On-Call (15–20 hours per week)
Industry: Medical Device – Neuro / Brain Surgery
Position Overview
We are seeking an experienced Clinical Research Associate (CRA) with a strong background in medical device clinical trials, specifically within neuro or brain surgery therapeutic areas. This is a part-time, on-call contract role requiring approximately 15–20 hours per week.
The CRA will be responsible for monitoring clinical trial sites, ensuring compliance with protocol, GCP guidelines, and regulatory requirements.
Key Responsibilities
- Ensure compliance with study protocol, ICH-GCP, and regulatory requirements
- Review source documents and verify data accuracy
- Monitor device accountability and safety reporting
- Support site initiation, interim monitoring, and close-out visits
- Identify and resolve site issues in a timely manner
- Maintain detailed monitoring reports and documentation
- Communicate effectively with investigators and study staff
Required Qualifications
- Bachelor’s degree in Life Sciences or related field
- Hands-on experience in Medical Device trials
- Experience in Neuro / Neurosurgery / Brain surgery studies strongly preferred
- Strong knowledge of ICH-GCP guidelines
- Experience with monitoring medical device clinical studies
- Ability to work independently in a part-time / on-call capacity
- Excellent documentation and communication skills
Preferred Qualifications
- Experience in high-risk implantable devices
- Prior experience with neurosurgical device trials
- Familiarity with FDA medical device regulations
Additional Information
- Part-time engagement (15–20 hours per week)
- Flexible schedule based on study needs
Thanks and Regards
Divya Kumari
divya@itengagements.com