CRA II​/Sr CRA - Sponsor-dedicated; Poland; Poland

CRA II/Sr CRA I – Sponsor Dedicated (Poland)

Position located in Poland, with preference for Central Poland. Responsibilities include site qualification and monitoring activities across the clinical study lifecycle.

• Perform site qualification, initiation, interim monitoring, management and close‑out visits (on‑site or remote) ensuring regulatory and protocol compliance.
• Evaluate site and staff performance, recommend site‑specific actions, communicate and escalate serious issues, and develop action plans.
• Maintain knowledge of ICH/GCP, regulations, and SOPs and ensure adherence.
• Verify informed consent procedures, protect confidentiality, and assess factors affecting subject safety and data integrity.
• Conduct source document review, verify CRF data accuracy, resolve queries remotely and on‑site, and drive query resolution to closure.
• Use hardware and software for data review and capture, verify compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation, storage, security, and dispensing checks in accordance with protocol.
• Review the Investigator Site File, reconcile with the Trial Master File, and ensure proper archiving of essential documents.
• Document activities through letters, reports, and logs per SOPs and monitoring plans.
• Support subject recruitment, retention, and awareness strategies.
• Enter data into tracking systems to monitor all observations, status, and action items.
• Understand project scope, budgets, and timelines; manage site‑level activities and communication to meet objectives.
• Adapt quickly to changing priorities to achieve goals and targets.
• Act as primary liaison with site personnel or collaborate with Central Monitoring Associate.
• Train and mentor junior CRAs; prepare for investigator meetings and sponsor interactions.
• Provide audit readiness support and participate in training sessions.
• For Real World Late Phase, utilize the business card title of Sr. Site Management Associate I.
• Additional responsibilities include:
  
  support throughout the study lifecycle, chart abstraction and data collection, collaboration with sponsor and affiliates, identification of scope issues, suggested site candidates, process improvements, development of country‑level informed consent forms, regulatory collaboration, and bid defense participation.

• 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.
• Good computer skills and openness to new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Basic critical‑thinking skills.
• Ability to manage required travel of up to 75% on a regular basis.

We are an equal opportunity employer. Syneos Health complies with all relevant legislation, including the Americans with Disabilities Act, and provides reasonable accommodations where appropriate to enable employees and applicants to perform essential job functions.