Clinical Trial Assistant

CVRx, Inc. • Brooklyn Park, MN

5d • Hybrid

About The Position

The Clinical Trial assistant will collaborate with cross-functional teams within the Clinical Research Department to assist in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements.

Requirements

• Bachelor’s Degree (health or life sciences preferred)
• 1-2 years experience in clinical research operations support
• Knowledgeable in 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, with the ability to effectively work across departments with diverse needs
• Excellent organizational and time management skills
• High work standards and ethics and a passion for success
• High attention to detail and emphasis on accuracy
• Ability to work in a team environment
• Proficient in Microsoft Office Suite (Office 365)

Nice To Haves

• 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

Responsibilities

• Maintain and organize clinical trial documentation, including study files, essential documents, and correspondence.
• Assist in the collection and tracking of study documents.
• Maintains 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 agenda’s, meeting minutes, and action items to Clinical team.
• Update TMF, CTMS, EDC management systems, when needed.
• Assists in trial activities such as processing payments, running reports, tracking study deliverables as needed.
• Maintaines trial related trackers, logs and internal dashboards,
• Support study start-up activities, including review and maintence of regulatory document and site initiation materials.
• Perform ad-hoc and cross-functional duties and/or projects, as assigned by manager or supervisor

Benefits

• Competitive Health & Dental Insurance options 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 in addition to a generous Flex PTO plan
• Generous paid time off for new parents
• Company-paid life insurance & disability options
• Unlimited growth opportunities in a growing company
• Endless training & learning opportunities
• Flexible Schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level