Clinical Study Coordinator

Location: Hybrid – Greater Boston Area 
Duration: 6 Month Part Time contract (20-30 hours per week) 
Compensation: $30–$50/hour depending on experience 
 

About CranioSense 

CranioSense is an early-stage medical device company developing novel, non-invasive technology to assess elevated intracranial pressure and neurological health. Our platform combines advanced sensing technologies, physiological waveform analysis, and machine learning to generate clinically meaningful insights that can improve patient care. Backed by venture capital, grant funding, and strategic research collaborations, CranioSense operates at the intersection of medtech, data science, and biomedical innovation. 

Position Overview 

CranioSense is seeking a Clinical Study Coordinator to join the product development team for its IHdetect system, an innovative solution for non-invasive intracranial pressure (ICP) assessment. The IHdetect product is a first of its kind low-cost, rapid, developed utilizing our expertise in physiologic sensing with near-infrared light.  IHdetect will enable clinicians to triage their patients’ ICP, minimizing the patients' risk of secondary brain damage associated with elevated ICP. The Clinical Study Coordinator will join the company's cross-disciplinary team to bring IHdetect through clinical verification and prepare it for clinical validation. 

We are looking for a self-motivated and enthusiast person with a passion for clinical research to improve human health and performance. The clinical study coordinator will be integral to the management of our clinical research program and play a key role in executing in house clinical studies. 

Key Responsibilities 

In this position, your responsibilities will include:  

  • 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 the respective 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 required for the clinical studies 

  • Ensure adequate training materials are created and that the clinical sites are appropriately trained 

  • Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice.  Assist with preparation and execution of investigator meetings. 

  • May participate in both internal and external clinical study-related audits.  

This position requires you to work in a small company, cross-functional, collaborative environment with external collaborators with all sorts of backgrounds and will require up to 10% travel. 

Preferred Qualifications 

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

  • Preferred 1-3 years’ experience with clinical coordination but willing to explore highly motivated candidates of appropriate backgrounds 

  • Experience with FDA, GCP, ICH E6, HIPAA and other clinical regulatory requirements 

  • Basic knowledge of Good Clinical Practice (GCP) and FDA regulations related to clinical trials (CITI or other applicable ethical training preferred) 

  • An interest in supporting the clinical research of medical devices 

  • Ability to handle multiple projects and effectively follow written/verbal instructions 

  • Excellent record-keeping, organizational, time management, decision-making, customer service, and interpersonal skills 

  • Ability to work independently with minimal supervision 

  • Must be comfortable maintaining professional demeanor when working with study subjects that may need to remove clothing items to attach study related devices/materials (ex. Applying ECG leads under someone’s clothing)  

Why Join CranioSense? 

  • Work on cutting-edge biomedical technology with real clinical impact 

  • Work directly with experienced data science, product, and engineering leaders on clinically meaningful biomedical datasets 

  • Gain hands-on experience taking raw physiological signals through preprocessing and feature engineering for downstream algorithm development 

  • Operate in a fast-moving, innovation-driven startup environment 

  • Opportunity for long-term employment following internship completion

Apply Now