Senior Clinical Research Associate

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

📋 Description

• Act as the main point of contact between the sponsor/CRO and designated sites, ensuring consistent communication with investigators and study coordinators.

• Monitor site performance, scheduling follow-up visits, adhering to data entry timelines, and resolving queries; escalate any identified risks.

• Assist with staff turnover at sites by providing retraining and updating delegation logs.

• Ensure that sites have sufficient resources, maintain equipment calibration, and manage the storage of investigational products or devices.

• Conduct on-site, remote, and risk-based monitoring visits, ensuring all visit documentation is completed.

• Execute source data verification and review follow-up data, including sleep study results, questionnaires, and compliance with device usage.

• Confirm adherence to informed consent procedures and manage re-consent following protocol or ICF amendments.

• Assess adverse events, serious adverse events, and device deficiencies to ensure accurate regulatory reporting.

• Detect and address protocol deviations and Corrective and Preventive Actions (CAPAs).

• Supervise the accountability, reconciliation, return, or destruction of investigational products/devices.

• Facilitate subject retention, minimize missed visits, track withdrawals, and manage long-term or end-of-study follow-up.

• Resolve Electronic Data Capture (EDC) data queries and assist in data cleaning, interim/final data reviews, and preparing for database lock.

• Ensure completeness of the Investigator Site File (ISF) and its reconciliation with the Trial Master File (TMF).

• Monitor Institutional Review Board (IRB) reviews, obtain amendment approvals, and manage safety reports and regulatory documentation.

• Prepare sites for sponsor audits and FDA inspections while supporting responses to any findings.

• Organize and execute site closeout visits along with post-study reconciliation, reporting, and regulatory tasks.

• Contribute to process improvements and lessons learned within the study team.

⛳️ Requirements

• A bachelor's degree in life sciences, nursing, pharmacy, or a related health field (or equivalent experience).

• A minimum of 2 years of independent on-site monitoring experience as a Clinical Research Associate (CRA) with a sponsor, CRO, or medical device company.

• Proficient understanding of ICH E6 Good Clinical Practice, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312 and/or 812), and HIPAA.

• Experience in monitoring studies through follow-up, database lock, and site closeout processes.

• Practical experience with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Trial Master Files (eTMF).

• A valid driver's license and the ability to travel to assigned sites.

• Authorization to work in the United States.

• Preferred: experience in sleep medicine, respiratory, cardiometabolic, or ENT trials, including obstructive sleep apnea (OSA) studies.

• Preferred: familiarity with polysomnography (PSG), home sleep apnea testing (HSAT), and CPAP or implantable/oral device studies.

• Preferred: experience with medical device trials, including Investigational Device Exemption (IDE) studies, device accountability, and reporting device deficiencies.

• Preferred: experience supporting FDA inspections or sponsor audits.

• Preferred: clinical research certification such as ACRP-CP, CCRA, or SOCRA CCRP.

🏝️ Benefits

• Opportunities for professional development and ongoing training.

• A supportive culture with close management.

• Commitment to equal opportunity, diversity, and inclusivity.

• Career opportunities in a global CRO environment and job security.

• Work dedicated to sponsors.

• Flexibility with home-based or remote work arrangements.