Job Description

Overview

The Clinical Research Associate at MED Institute will support clinical study operations through monitoring and site management activities, ensuring studies are conducted, documented, and reported in accordance with protocols, MED Institute procedures, and regulatory requirements. Responsibilities may include start-up, implementation, and both on-site and remote monitoring. The role is important in maintaining patient safety, data integrity, and audit-readiness across assigned investigative sites.

MED Institute partners with medical device companies to bring innovative technologies to market. With expertise in regulatory strategy, clinical trial design, and technical consulting, our cross-disciplinary team supports clients from concept through commercialization. We're passionate about improving healthcare through collaboration, innovation, and service excellence.

Responsibilities

• Conduct remote and on-site monitoring activities, issuing and resolving queries to maintain complete, accurate, and audit-ready datasets.
• Perform qualification, initiation, routine, and closeout visits; assess protocol adherence, regulatory compliance, and site performance; provide training and support to investigators and site staff.
• Identify site-level issues, deviations, or risks; escalate as needed and support timely resolution.
• Prepare clear, accurate, and timely monitoring reports, follow-up letters, and site documentation.
• Support study start-up activities, including feasibility assistance, regulatory document collection/QC, IRB/EC submissions, and informed consent review.
• Maintain and reconcile essential documentation, including the Investigator Site File, Trial Master File, IRB/EC approvals, CVs, agreements, licenses, and insurance.
• Perform investigative product accountability and verify proper storage, dispensing, and documentation.
• Review EDC data, source documentation (as applicable), and patient profiles; collaborate with data management to resolve discrepancies.
• Build and maintain productive relationships with investigators, site staff, sponsors, and internal project teams to support study objectives.
• Communicate study requirements and operational updates to sites on an ongoing basis.
• Complete ad-hoc assignments as assigned.

Qualifications

• Bachelor's degree in life sciences, nursing, allied health, or other scientific/healthcare discipline;
• CCRP or ACRP certification preferred;
• Demonstrated experience as a CRA with independent monitoring responsibilities;
• Proficiency with EDC systems, CTMS/TMF platforms, electronic tools, and standard office software;
• Conscientious, influential person with an outstanding work ethic and strong personal discipline;
• Willingness and capability to handle multiple projects and responsibilities;
• Excellent organizational and problem-solving skills;
• Excellent written, listening, and verbal communication skills; and
• Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues.
• Willing and able to travel, as needed. (up to 50%)
• Qualified candidates must be legally authorized to be employed in the United States. MED Institute does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN) for this employment position.

Job Tags

Full time, H1b, Work at office, Remote work

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