Syneos Health
November 16, 2021
North America - USA-Illinois-Home-Based
Job Type
Work Setting
Remote / Home-based


  • 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 the 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 review 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) labeled, 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.   
  • Maintains a 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
  • 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
  • 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 treatment patterns, patient advocacy, and Health Care Provider (HCP) associations


What we’re looking for

  •   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


Drop files here browse files ...
Resume, cover letter, or other documents as required per the job description

Related Jobs

December 1, 2021
December 1, 2021
Medical Content Marketing Writer   Washington, DC new
December 1, 2021
Are you sure you want to delete this file?