Senior Clinical Research Associate

🔥 13 hours ago

🐊 Florida – Remote

🐊 Florida – Remote

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Serve as the primary sponsor/CRO contact for assigned sites and maintain regular communication with investigators and study coordinators • Track site performance, follow-up visit schedules, data entry timelines, and query resolution; escalate risks • Support site staff turnover through retraining and delegation log updates • Ensure adequate site resources, equipment calibration, and investigational product or device storage • Conduct on-site, remote, and risk-based monitoring visits and complete visit documentation • Perform source data verification and review of follow-up data, sleep study results, questionnaires, and device adherence data • Verify informed consent compliance and re-consent after protocol or ICF amendments • Review adverse events, serious adverse events, and device deficiencies for accurate regulatory reporting • Identify and follow up on protocol deviations and CAPAs • Oversee investigational product/device accountability, reconciliation, return, or destruction • Support subject retention, missed-visit reduction, withdrawal tracking, and long-term/end-of-study follow-up • Resolve EDC data queries and support data cleaning, interim/final data reviews, and database lock preparation • Ensure ISF completeness and reconciliation with the TMF • Track IRB reviews, amendment approvals, safety reports, and regulatory documentation • Prepare sites for sponsor audits and FDA inspections and support responses to findings • Plan and conduct site closeout visits and post-study reconciliation, reporting, and regulatory activities • Contribute to lessons learned and study-team process improvements

🎯 Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related health field (or equivalent experience) • 2+ years of independent on-site monitoring experience as a CRA with a sponsor, CRO, or medical device company • Working knowledge of ICH E6 Good Clinical Practice, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312 and/or 812), and HIPAA • Experience monitoring studies through follow-up, database lock, and site closeout • Hands-on experience with EDC, CTMS, and eTMF systems • Valid driver's license and ability to travel to assigned sites • Authorization to work in the United States • Preferred: experience in sleep medicine, respiratory, cardiometabolic, or ENT trials, including OSA studies • Preferred: familiarity with PSG, HSAT, and CPAP or implantable/oral device studies • Preferred: medical device trial experience, including IDE studies, device accountability, and device deficiency reporting • Preferred: experience supporting FDA inspections or sponsor audits • Preferred: clinical research certification such as ACRP-CP, CCRA, or SOCRA CCRP

🏖️ Benefits

• Professional development and continuous training • Supportive culture and close management • Equal opportunity, diversity, and inclusivity • Global CRO career opportunities and job security • Sponsor-dedicated work arrangement • Home-based/remote work arrangement

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