Syneos Health

Clinical Research Associate II – Sponsor Dedicated

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: Canada

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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
  • For 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 project 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, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
  • May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).
  • 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.
  • For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out
  • Knowledge of local requirements for real world late phase study designs
  • Chart Abstraction activities and data collection
  • Collaboration with Sponsor affiliates, medical science liaisons and local country staff

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
  • We are passionate about developing our people, through career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program
  • We are committed to building an inclusive culture – where you can authentically be yourself.
Applicant Tracking System Keywords

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

Hard Skills & Tools
site qualificationsite initiationinterim monitoringsite managementsource document reviewclinical data integrityquery resolutioninvestigational product (IP) managementdata entrychart abstraction
Soft Skills
communication skillspresentation skillsinterpersonal skillsjudgmentadaptabilityproblem-solvingteam collaborationaction planningdiligenceproject management
Certifications
Bachelor’s degreeRNGood Clinical Practice (GCP) certification