CRA II

Overview

CRA II – Syneos Health®. We are a leading fully integrated biopharmaceutical solutions organization accelerating customer success by translating clinical, medical affairs and commercial insights into outcomes. Our Clinical Development model centers the customer and the patient, aiming to simplify and streamline work to help our customers and colleagues. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to accelerate the delivery of therapies and change lives.

Work here matters everywhere.

Why Syneos Health

• 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 a total rewards program.
• We are committed to our Total Self culture where you can authentically be yourself, united globally and supported in taking care of our people.
• We are building a diverse, inclusive environment where ideas, backgrounds and perspectives are valued and where everyone feels they belong.

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site performance and provide recommendations; communicates/escalates serious issues and develops action plans. Maintains working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs.
• Verifies informed consent processes and documentation; protects confidentiality; assesses factors affecting subject safety and data integrity at investigator sites (e.g., protocol deviations, pharmacovigilance issues).
• Per CMP/SMP: assesses site processes; conducts Source Document Review; verifies CRF data accuracy and completeness; applies query resolution remotely and on site; uses hardware/software to support data review and capture; ensures site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensing/administration per protocol; ensures correct labeling, importation and release/return of IP as appropriate.
• Routinely reviews the Investigator Site File (ISF) for accuracy and reconciles with the Trial Master File (TMF); ensures archiving of essential documents per local guidelines and regulations.
• Documents activities with letters, trip reports, logs and other required documents; supports recruitment and retention strategies; enters data into tracking systems to monitor observations and action items.
• Manages scope, budgets and timelines for assigned activities; adapts to changing priorities to achieve goals; may act as primary liaison with study site personnel or with Central Monitoring Associate; ensures training and compliance of sites and project team members.
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and attends training as required by the project.
• Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
• Maintains knowledge of ICH/GCP and applicable regulations; completes required training. For Real World Late Phase, the CRA II may use the title Site Management Associate II and responsibilities include: site support through the study lifecycle, chart abstraction, collaboration with Sponsor affiliates, and potential junior staff training; identify out-of-scope activities; suggest potential sites based on local knowledge.

• Bachelor’s degree or RN in a related field or equivalent experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong computer skills and ability to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
• US ONLY:
  Employment may require providing medical/personal information for site access; compliance with the Site’s access requirements is a condition…