Experienced Clinical Research Associate – Sponsor Dedicated

Syneos Health

Experienced Clinical Research Associate managing site activities and ensuring compliance in clinical studies. Collaborating with various stakeholders and conducting site monitoring visits and documentation.

Posted 6/5/2026full-timeRemote • Alabama, Florida, Mississippi, South Carolina • 🇺🇸 United StatesJuniorMid-Level💰 $70,100 - $126,100 per yearWebsite

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

site qualificationsite initiationinterim monitoringsite managementclinical data integrityquery resolutionSource Document Reviewelectronic data captureinvestigational product (IP) managementarchiving essential documents

Soft Skills

communication skillspresentation skillsinterpersonal skillsjudgmentadaptabilityproblem-solvingteam collaborationaction planningdiligenceproject management

Tools & Technologies

tracking systemsClinical Monitoring PlanSite Management PlanTrial Master FileInvestigator Site Filedata review softwarehardware for clinical studiesSOPsclinical training systemsaudit readiness tools

Certifications & Qualifications

Bachelor’s degreeRNGood Clinical Practice (GCP) certification

Industry Keywords

ICH GuidelinesGood Pharmacoepidemiology Practice (GPP)regulatory complianceclinical monitoringpatient safetyprotocol compliancepharmacovigilancesubject recruitmentaudit preparationinvestigator meetings

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 according to 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.
Verifies issues or risks associated with blinded or randomized information related to IP.
Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF).
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.
Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
Must be able to quickly adapt to changing priorities to achieve goals/targets.
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

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
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time