Summary
The In-House CRA will be responsible for supporting the clinical operations team in planning, executing, and managing medical device clinical trials while ensuring compliance with regulatory standards and maintaining high-quality documentation within the Trial Master File (TMF) system as well as assisting in the review of study data entered into the electronic data capture (EDC) system. This role demands a high degree of flexibility, organization, and problem-solving skills, as you will work within a fast-paced and evolving start-up environment
Additionally, the position involves providing invaluable feedback to collaborate with the Clinical and Product teams to enhance both trial and product design. As a key member of our team, you will have the opportunity to make a significant impact on the lives of patients while advancing your career in the field of clinical research.
This will initially be an 18-month temporary position with the possibility of further opportunities within the company.
Responsibilities
- Assist in the coordination and oversight of clinical trials for medical devices in compliance with regulatory requirements (FDA, ISO, ICH-GCP).
- Work closely with study sites to facilitate site engagement, startup, and maintenance throughout the study lifecycle.
- Support the clinical team in monitoring and managing site performance, including patient enrollment and protocol adherence.
- File, maintain, review, and ensure the completeness and accuracy of the TMF to ensure regulatory compliance.
- Perform periodic quality checks on TMF documentation to ensure it meets internal and external requirements.
- Assist in the implementation of TMF best practices, including version control, document indexing, and archival processes.
- Oversee the timely and accurate entry of clinical trial data into electronic data capture (EDC) systems.
- Coordinate the onboarding of new clinical sites and users to the EDC platform.
- Support data monitoring efforts, ensuring data integrity and addressing any discrepancies or issues as they arise.
- Manage the timely shipment and delivery of medical devices and supplies to clinical trial sites, ensuring all necessary materials are available for study procedures.
- Maintain accurate records of shipments, inventory, and site supplies in line with study requirements.
- Serve as the primary point of contact for study sites regarding logistical and operational matters, including troubleshooting and resolving issues related to medical device shipments.
- Assist in the coordination of international investigator meetings
- Participate in study team meetings and contribute to the development of clinical trial protocols, reports, and other study-related documents
Skills and Experience
- Knowledge of medical device clinical trial processes and regulations (ICH-GCP, FDA, ISO 14155)
- Strong organizational and project management skills with attention to detail
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across internal and external teams (e.g. – hospitals, clinical research organizations (CROs))
- Ability to work independently in a fast-paced environment
Qualifications
- Bachelor’s degree in life sciences, healthcare, or related field
- 3-5 years of experience in clinical research, specifically in medical device trials
- Proven experience in managing TMFs and ensuring regulatory compliance.
- Proficiency in EDC systems (Viedoc EDC preferred)
- Occasional domestic travel may be required, though it will be infrequent.
Benefits
- Salary and equity compensation offered
- Health, dental, vision and life insurance
- Paid time off as well as major national holidays
About Liberate Medical
Liberate Medical is a clinical / commercial stage medical device company that develops neuromuscular electrical stimulation devices to improve the quality and reduce the cost of care for patients with pulmonary disorders. The company’s lead product, the VentFree® respiratory muscle stimulator, is designed to prevent breathing muscle atrophy and reduce the time that a patient spends on mechanical ventilation. Two independent pilot RCTs found a shorter ventilation duration and ICU length of stay in patients who received VentFree compared with standard of care. In doing so, VentFree is expected to save lives, reduce patient morbidity and significantly lower provider costs. VentFree has been granted Breakthrough Device Designation and Emergency Use Authorization by the FDA and CE clearance in the EU.
We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information, or any other protected category and to comply with applicable federal, state, and local regulations regarding discrimination in employment.
