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Prime Path Medtech™ · 22 hours ago

Clinical Research Associate (CRA)

United States

Part-time

Remote

Entry, Mid Level

$60K/yr - $65K/yr

1+ years exp

Prime Path Medtech, Inc. is a growing company that enables medical device innovation across the healthcare industry. They are seeking a motivated Clinical Research Associate to support clinical trials and ensure compliance with regulatory requirements while working in a hybrid model.

Artificial Intelligence (AI)Clinical TrialsTraining

Responsibilities

Conduct clinical site monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements

Review and verify clinical data for accuracy, completeness, and consistency with source documentation

Support protocol development and implementation across multiple medical device studies

Assist with regulatory submission preparation and maintenance of regulatory documentation

Serve as a liaison between clinical sites, sponsors, and internal teams

Participate in investigator meetings, site training sessions, and study start-up activities

Identify and report protocol deviations and adverse events in accordance with regulations

Maintain study files and ensure proper documentation practices

Support the preparation of clinical study reports and other study-related documents

Collaborate with cross-functional teams including regulatory, quality, and project management

Qualification

GCPFDA regulationsISO 14155Clinical research experienceClinical trial management systemsMicrosoft OfficeAttention to detailOrganizational skillsWritten communicationVerbal communication

Required

Bachelor's degree in life sciences, nursing, or related field

1-5 years of clinical research experience (medical device experience preferred)

Strong understanding of GCP, FDA regulations, and ISO 14155

Excellent attention to detail and organizational skills

Strong written and verbal communication abilities

Ability to work independently in a remote environment

Proficiency with Microsoft Office and clinical trial management systems

Ability to travel approximately 30% of the time for site monitoring and study-related activities

Preferred

medical device experience

Benefits

Remote work flexibility

Opportunity to work with cutting-edge medical device technology

Collaborative team environment that values innovation and initiative

Strong opportunities for professional growth and career advancement

Company

Prime Path Medtech™

We partner with companies at all stages to achieve business outcomes – from strategic regulatory planning to all phases of the product development process to get your product on the market.

Founded in 2017

Minneapolis, Minnesota, USA

11-50 employees