Clinical Trial Assistant

CVRx•Brooklyn Park, MN

3d•$60,000•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.
Maintains 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