MedTech Clinical Trials Coordinator

CranioSense, LLC; Boston (MA); On-site; USD 65,000 - 75,000; Full time

Job summary

CranioSense in Boston, MA is seeking a Clinical Study Coordinator to join the product development team for the IHdetect system, a non‑invasive ICP assessment technology. You will manage clinical studies from design through initiation, coordinating sites and regulators.

The role requires self‑motivation, strong organizational skills, and ability to travel up to 10%. You will collaborate with data science, product, and engineering teams to advance clinical research for a medical device.

Qualifications

• BS in Life Sciences, Healthcare, Biomedical Engineering or relevant experience.
• 1–3 years’ clinical coordination experience preferred.
• Experience with FDA, GCP, ICH E6, HIPAA and regulatory requirements.
• GCP knowledge; training (CITI) preferred.
• Interest in clinical research for medical devices.
• Ability to handle multiple projects and follow written/verbal instructions.
• Excellent record-keeping, organizational, time management, and interpersonal skills.
• Ability to work independently with minimal supervision.
• Comfort with subjects who may need to remove clothing to attach study devices.

Responsibilities

• Serve as the primary contact for assigned clinical studies.
• Support the design, preparation, planning, implementation and review of clinical studies to support new medical device development and regulatory approval.
• Recruit, consent and conduct clinical study or trial activities as outlined in protocols.
• Assist in the review and organization of clinical data according to IRB, Internal SOP, FDA ICH/GCP and HIPAA standards.
• Work with hospital and government review boards to gain necessary approvals for the clinical studies.
• Ensure training materials are created and sites are trained.
• Work with investigators to ensure protocol compliance and ethical practice; assist with investigator meetings.
• May participate in internal and external clinical study audits.
• Up to 10% travel in a small, cross‑functional startup environment.

Skills

Clinical coordination

IRB/HIPAA knowledge

Regulatory knowledge

Documentation & records

Communication skills

Education

BS in Life Sciences, Healthcare, Biomedical Engineering or relevant experience

Job description

CranioSense in Boston, MA is seeking a Clinical Study Coordinator to join the product development team for the IHdetect system, a non‑invasive ICP assessment technology. You will manage clinical studies from design through initiation, coordinating sites and regulators.

The role requires self‑motivation, strong organizational skills, and ability to travel up to 10%. You will collaborate with data science, product, and engineering teams to advance clinical research for a medical device.