Clinical Research Associate – Full-Service

Syneos Health

Clinical Research Associate at Syneos Health managing site qualifications and monitoring compliance. Ensuring overall performance and regulatory adherence for clinical trials across remote US locations.

Posted 6/12/2026full-timeRemote • Arizona, Maine, North Carolina, Ohio, Rhode Island • 🇺🇸 United StatesJuniorMid-LevelWebsite

ATS Keywords

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Hard Skills

site qualificationsite initiationinterim monitoringsite managementsource document reviewclinical data integrityquery resolutionelectronic data captureinvestigational product inventoryprotocol compliance

Soft Skills

communication skillspresentation skillsinterpersonal skillsjudgmentdiligenceproblem-solvingaction planningteam collaborationadaptabilitytime management

Tools & Technologies

clinical study data review softwarecase report form (CRF)SOPsClinical Monitoring PlanSite Management Planhardware for data capturecommunication logstrip reportsconfirmation lettersfollow-up letters

Certifications & Qualifications

Bachelor’s degreeRNGood Clinical Practice certification

Industry Keywords

ICH-GCPGood Pharmacoepidemiology Practiceregulatory complianceclinical monitoringpharmacovigilancesubject recruitmentretention strategieslocal guidelinesclinical trialsproject management

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
Demonstrates diligence in protecting the confidentiality of each subject/patient
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP)
Conducts Source Document Review of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
Verifies site compliance with electronic data capture requirements
May perform investigational product (IP) inventory, reconciliation and reviews storage and security
Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
Supports subject/patient recruitment, retention and awareness strategies
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met

Requirements

What you’ll need

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis

Benefits

Comp & perks

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Flexible paid time off (PTO) and sick time