Clinical Trial Assistant

Overview CVRx pioneers unique therapies that harness and harmonize the body’s natural systems. If your culture and values align, join our mission to help others live better lives. Location & Hybrid Hybrid onsite at Brooklyn Park, MN headquarters; ideal candidate will reside locally. Responsibilities Maintain and organize clinical trial documentation, including study files, essential documents, and correspondence. Assist in the collection and tracking of study documents. Maintain the Trial Master File (TMF) to ensure inspection‑readiness at all times, including quality control review of documents to ensure compliance with GCP. Track and follow‑up on outstanding site documentation and administrative requirements. Assist with data reconciliation and maintenance of administrative and operational data within clinical trial systems. Prepare and distribute meeting agendas, meeting minutes, and action items to the clinical team. Update TMF, CTMS, EDC management systems when needed. Assist in trial activities such as processing payments, running reports, tracking study deliverables as needed. Maintain trial‑related trackers, logs, and internal dashboards. Support study start‑up activities, including review and maintenance of regulatory documents and site initiation materials. Perform ad‑hoc and cross‑functional duties and/or projects as assigned by manager or supervisor. Required Education, Training and Job‑Related Experience Bachelor’s Degree (health or life sciences preferred) 1‑2 years experience in clinical research operations support Knowledge of FDA regulations, ISO 14155, and GCP Experience working in Electronic Trial Master File (eTMF) systems (e.g., Florence). Experience working in Electronic Data Capture (EDC) systems (e.g., iMednet). Excellent interpersonal, verbal, and written communication skills, and ability to work across departments. Excellent organizational and time‑management skills. High work standards, ethics, and passion for success. High attention to detail and emphasis on accuracy. Ability to work in a team environment. Proficiency in Microsoft Office Suite (Office 365). Preferred Education, Training and Job‑Related Experience Prior experience with cardiovascular medical device research studies. Prior experience working with disruptive medical devices. Prior experience in a growth or start‑up stage company. Working Conditions and Required Physical Effort Normal office conditions. Must be able to sit/stand/walk 8 hours per day. Ability to travel for business up to 10% by car and/or air. Visa Sponsorship CVRx is unable to provide employment visa sponsorship for this position. Candidates must be legally authorized to work in the United States without current or future sponsorship. Benefits Competitive Health & Dental Insurance with generous company contributions. Company contributions to an HSA with a high deductible insurance plan selection. 401(k) with a company match. Employee Stock Purchase Plan (ESPP) & stock option and restricted stock unit grants. 12 company‑paid holidays per year plus a generous Flex PTO plan. Generous paid time off for new parents. Company‑paid life insurance & disability options. Unlimited growth opportunities. Endless training & learning opportunities. Flexible schedule. EEO Statement CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Contact If you need assistance or an accommodation due to a disability, you may contact us at View email address on click.appcast.io . #J-18808-Ljbffr