Experienced Clinical Research Associate Service - Oncology

Syneos Health

Asheville, NCFull-timePosted May 8, 2026

Behavioral Health Market Context

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Qualifications

  • •Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labelled, imported and released/returned

Responsibilities

  • •Job Responsibilities 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
  • •Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
  • •Assesses site processes
  • •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
  • •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
  • •16 more items(s)
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