CRA II, Core BU

Description

CRA II, Core BU, Singapore. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and patient experience, with a focus on simplifying and streamlining work to be easier for both clients and teams.

The scope includes work in Functional Service Provider partnerships or Full-Service environments, with collaboration among teams to accelerate delivery of therapies and impact patient outcomes.

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance. Evaluates site and staff performance and communicates/escalates serious issues; develops action plans and maintains working knowledge of ICH/GCP guidelines and applicable regulations and SOPs.
• Verifies informed consent processes and protects subject confidentiality. Assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations/violations and pharmacovigilance issues).
• Per the CMP/SMP: assesses site processes, conducts source document reviews, verifies CRF data accuracy/completeness, applies query resolution techniques remotely and on-site, drives query closure within timelines, and supports data capture and electronic data capture compliance.
• May perform investigational product (IP) inventory, reconciliation and reviews of storage and security. Verifies IP dispensing per protocol and handles labeling, importation and return/release in accordance with GCP/local regulations.
• Routinely reviews Investigator Site File (ISF) for accuracy and completeness; reconciles with Trial Master File (TMF) and ensures archiving of essential documents per guidelines and regulations.
• Documents activities via letters, logs, trip reports and other required documents; supports recruitment, retention and awareness strategies; enters data into tracking systems to monitor observations and action items.
• Understands project scope, budgets, and timelines; manages site-level activities and communications to meet deliverables; adapts to changing priorities.
• Acts as primary liaison with study site personnel or in collaboration with Central Monitoring Associate; ensures sites and team members are trained and compliant with requirements.
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project meetings and training as required.
• Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
• Maintains knowledge of ICH/GCP and applicable guidance; completes required training. For Real World Late Phase, may hold the business card title of Site Management Associate II with additional duties: ongoing site support, chart abstraction, collaboration with sponsor affiliates and MSLs, training junior staff as needed, and identifying out-of-scope activities.

• 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 regulatory requirements
• Proficient computer skills and adaptability to new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
• US ONLY:
  Compliance with site access requirements and privacy notices as part of employment; adherence to site information requests as a condition of employment

Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. Learn more about Syneos Health by visiting our site.

Tasks listed are not exhaustive. The company may assign other tasks as needed. Equivalent experience, skills, and education will be considered. The company may determine what constitutes equivalent qualifications. Nothing herein should be construed as an employment contract. The company complies with applicable disability laws and provides reasonable accommodations where appropriate to perform essential functions.