Clinical Research Associate I
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- 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 Pharmacoepidemiological Practices (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 with guidance 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.
- 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 project data review and capture.
- Verifies site compliance with electronic data capture requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Requirements
- 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
- health insurance
- career development
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite initiationinterim monitoringsite managementsource document reviewclinical data verificationquery resolutionelectronic data captureregulatory complianceGood Clinical Practice
Soft skills
communication skillspresentation skillsinterpersonal skillsjudgmentdiligenceproblem-solvingaction planningteam collaborationadaptabilitytime management
Certifications
Bachelor’s degreeRNGood Clinical Practice certification