Senior Clinical Research Associate II

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee, supervise, and finalize the management of assigned clinical trial investigator sites.

• Ensure the safety of patients, the quality of study execution, adherence to regulatory/GCP compliance, and alignment with Pfizer standards.

• Manage operational clinical trial tasks from site initiation to database lock.

• Act as the main point of contact for designated investigator sites and promote communication among study teams, vendors, and sites.

• Provide coaching and training to site staff and deliver protocol training.

• Assist in enrollment, site activation, and recruitment efforts.

• Conduct both onsite and remote/electronic monitoring for initiation, routine checks, and closure activities.

• Monitor adverse events and serious adverse events, following up with investigators and the Drug Safety Unit.

• Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, and track recruitment and study progress.

• Identify and address site-related issues, developing corrective and preventative measures.

• Resolve data queries and prepare for site closure activities.

• Oversee the receipt, handling, accounting, storage, and disposal of investigational products.

• Support database release and conduct unblinded monitoring as necessary.

• Maintain knowledge of products, protocols, and therapy areas while ensuring patient safety and eligibility.

• Lead Quality Event remediation and assist in audits and CAPA activities.

• Mentor and train Clinical Research Associates (CRAs) and Senior CRAs I.

• Serve as a subject matter expert (SME) for CRA processes and engage in or lead process improvement initiatives.

• Perform Site Care Partner responsibilities on small projects or with guidance on larger projects.

• Conduct co-monitoring activities.

⛳️ Requirements

• Relevant experience and/or qualifications to effectively perform senior clinical research associate site management and monitoring duties.

• Comprehensive understanding of the product, protocol, and therapy area.

• Familiarity with applicable laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans, and Standard Operating Procedures (SOPs).

• Ability to manage relationships with investigator sites and resolve protocol-related challenges.

• Competence in conducting onsite, remote/electronic monitoring, and closure tasks.

• Capability to monitor adverse events (AEs) and serious adverse events (SAEs) while collaborating with the Drug Safety Unit.

• Proficiency in handling investigational product receipt, management, accounting, storage, and disposal.

• Ability to assist in database release processes.

• Capacity to perform unblinded monitoring responsibilities as required.

• Skill in mentoring and training Clinical Research Associates and Senior Clinical Research Associates I.

• Ability to serve as a subject matter expert (SME) for CRA-related processes.

• Experience in participating in or leading working groups and process improvement initiatives.

• Capability to undertake Site Care Partner duties for minor projects or under supervision for larger ones.

• Proficiency in conducting co-monitoring activities.

🏝️ Benefits

• Annual bonus of 15%.

• Corporate benefits according to Pfizer Pay Policy, including Medicover, Multisport, life insurance, private pension plan, and more.

• Flexible workplace culture that promotes work-life balance.

• Reasonable accommodations to support disability inclusion.