CRA II

Syneos Health/ inVentiv Health Commercial LLC

Las Cruces, NMFull-timePosted Apr 30, 2026

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Qualifications

  • •Knowledge of local requirements for real world late phase study designs

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 performance of site and site staff and to provide recommendations regarding site-specific actions; communicates/escalates serious issues to the project team and develops action plans
  • •Maintains 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
  • •Demonstrates diligence in protecting confidentiality
  • •Assesses factors that might affect subject/patient safety and data integrity at an investigator/physician site such as protocol deviations/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 to drive query resolution to closure within agreed timelines
  • •Utilizes available hardware and software to support data review and capture
  • •Verifies site compliance with electronic data capture requirements
  • •May perform investigational product (IP) inventory, reconciliation and storage reviews
  • •Verifies IP has been dispensed and administered 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 labelled, imported and released/returned
  • •Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
  • •Reconciles ISF with the Trial Master File (TMF)
  • •Ensures the investigator/physician site is aware 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 per SOPs and the Clinical Monitoring Plan/Site Management Plan
  • •Supports subject/patient recruitment, retention and awareness strategies
  • •Enters data into tracking systems to track all observations, ongoing status and action items to resolution
  • •For assigned activities, understands project scope, budgets, and timelines; manages site-level activities and communication to ensure project objectives, deliverables and timelines are met
  • •Quickly adapts to changing priorities to achieve goals and targets
  • •Acts 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 sponsor face-to-face meetings
  • •Participates in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions according to project requirements
  • •Provides guidance at the site and project level towards audit readiness standards and supports preparation for audits and follow-up actions
  • •Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required
  • •For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II
  • •Additional responsibilities include site support throughout the study lifecycle from site identification through close-out
  • •Chart abstraction activities and data collection
  • •The SMA II may be requested to train junior staff
  • •Identify and communicate out-of-scope activities to Lead CRA/Project Manager
  • •Proactively suggest potential sites based on local knowledge of…
  • •34 more items(s)
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