Clinical Research Associate

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Prepare, gather, disseminate, and uphold trial master files and regulatory documents at investigative sites.

• Conduct pre-study site evaluations and assess site feasibility and operational procedures.

• Generate reports and engage in the selection of investigators and study sites.

• Execute clinical study site initiation visits and train site staff on sponsor and regulatory obligations.

• Perform site monitoring visits and address significant problems and concerns.

• Ensure that clinical studies adhere to state and federal regulations, guidelines, and policies.

• Examine site files, records, case report forms, and source documents for completeness, accuracy, consistency, and compliance.

• Identify deficiencies and discrepancies and provide corrective training or implement corrective actions.

• Review and resolve queries regarding case report forms and data issues.

• Collaborate with the Clinical Project Manager, interdisciplinary study teams, and both internal and external research partners.

• Assist with device preparation, coordination of shipments, and maintaining accountability records.

⛳️ Requirements

• Bachelor’s degree or higher from an accredited institution and three (3) years of experience in clinical research, biomedical, or the medical device industry, including two (2) years of direct Clinical Research Associate (CRA) experience in clinical study monitoring activities; OR a High School Diploma/GED with seven (7) years of relevant industry experience, including five (5) years of direct CRA experience in clinical study monitoring activities.

• Direct CRA monitoring experience with medical device clinical studies.

• Experience in a hospital, clinical setting, or medical laboratory.

• Proficiency in using Smartsheet, Microsoft Copilot, and Microsoft 365 applications.

• Experience in preparing and delivering verbal, written, and presentation communications regarding project status, issues, and escalations.

• Ability to identify issues, assess potential solutions, and facilitate the resolution of business or project challenges.

• Capability to prioritize, plan, track, and evaluate deliverables against set requirements and timelines.

• Competence in managing multiple concurrent tasks and adjusting priorities based on evolving business needs and deadlines.

• Must have legal authorization to work in the country of employment without requiring sponsorship for employment visa status.

🏝️ Benefits

• Medical, Dental & Vision.

• Health Savings Accounts.

• Health Care & Dependent Care Flexible Spending Accounts.

• Disability Benefits.

• Life Insurance.

• Voluntary Benefits.

• Paid Absences.

• Retirement Benefits.