CRA II | Sponsor Dedicated | Oncology; Home-Based - Buffalo, NY

Overview

Updated: October 24, 2025
Location: USA-NY-Remote
Job :

CRA II | Sponsor Dedicated | Oncology (Home-Based - Buffalo, NY) is part of Syneos Health, a leading fully integrated biopharmaceutical solutions organization. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and patient, aiming to simplify and streamline work to improve how we deliver for both clients and patients.

Whether in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with a team of problem solvers to accelerate therapy delivery and improve lives.

Why Syneos Health matters: we are 29,000 employees across 110 countries, committed to a diverse and inclusive culture and to developing our people through training, career development, and recognition.

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and GPP/protocol compliance. Evaluates site performance and site staff, provides recommendations, and communicates/escalates serious issues with action plans. Maintains working knowledge of ICH/GCP Guidelines, applicable regulations, and company SOPs/processes.
• Verifies informed consent processes, protects subject confidentiality, and 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, resolves queries remotely or on-site, and supports data capture and EDIs. Ensures site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and storage/security reviews. Verifies IP dispensing and administration per protocol and ensures proper labeling, importation, and release/return of IP as applicable.
• Routinely reviews the Investigator Site File (ISF) for accuracy and completeness, reconciles with the Trial Master File (TMF), and ensures archiving of essential documents per local guidelines and regulations.
• Documents activities via letters, trip reports, logs, and SOP-required project documents. Supports recruitment and retention strategies and enters data into tracking systems to monitor observations, status, and action items.
• Manages project scope, budgets and timelines for assigned activities; adapts to changing priorities to meet objectives and timelines. May serve as primary liaison with study site personnel or in collaboration with Central Monitoring.
• Ensures training and compliance of sites and site team members with applicable requirements. Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and training sessions as required.
• Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
• Maintains knowledge of ICH/GCP and relevant regulations; completes required training. For Real World Late Phase, the CRA II may use the business card title of Site Management Associate II.
  
  Additional responsibilities include:
  
  site support throughout the study lifecycle, chart abstraction, collaboration with sponsor affiliates and LCMs, and potential training of junior staff. May identify out-of-scope activities and communicate them to the Lead CRA/Project Manager.

• 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
• Strong computer skills and openness 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; some sites may request additional information for entry. Must comply with site requests as a condition of employment. Failure to provide information may bar entry.

The salary range for this position is $70,100.00 – $. Base pay varies based on qualifications, skills, and experience. Benefits may include a company car or car allowance, medical/dental/vision benefits, 401(k) company match, eligibility for Employee Stock Purchase Plan, potential bonuses, and paid time off. Paid sick time eligibility may vary by location and is compliant with applicable laws.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodation during the application process, contact