Syneos Health – USA Hiring for Clinical Research Associate I Job at Remote Full Time

The Clinical Research Associate I (CRA I) will perform monitoring and site management activities for
Phase I-IV clinical research projects to assess the progress of clinical projects at assigned
investigative/physician sites (either on-site or remotely) and to ensure clinical projects are conducted,
recorded, and reported in accordance with the protocol, Company, and Sponsor standard operating
procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. Requires
guidance and oversight, while developing an understanding of drug development and
commercialization process.

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 Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate the overall performance of site and site staff and to provide recommendations regarding site specifications; 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 the subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• 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, 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 sponsors 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 toward audit readiness standards and supports
  preparation for audit and required follow-up actions.

Minimum Qualifications:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Prior Clinical Research experience preferred
• 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 travel 75% of the time