Clinical Research Associate

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

📋 Description

• Oversee, track, and finalize the assigned clinical trial investigator sites.

• Ensure the safety of patients and the quality of study execution in compliance with laws, Good Clinical Practices, and Pfizer standards.

• Foster relationships with investigator sites and assist with enrollment, database access, site quality, compliance, and staff engagement.

• Address protocol-related challenges and collaborate with the Site Care Partner and study team.

• Act as the main contact for designated investigator sites throughout the study process.

• Facilitate communication among study team members, vendors, and investigator sites.

• Develop, mentor, and train site personnel on protocols and compliance standards.

• Participate in investigator meetings as necessary.

• Assist in site activation and recruitment strategies.

• Conduct remote evaluations of e-diary data.

• Perform onsite, remote, and electronic monitoring for site initiation, ongoing monitoring, and site closure.

• Monitor Adverse Events (AEs) and Serious Adverse Events (SAEs), collaborating with the Drug Safety Unit.

• Submit necessary reports, documentation, updates, and tracking within stipulated timeframes.

• Identify and address site issues, developing corrective and preventive measures.

• Resolve data inquiries and execute investigator site close-out tasks.

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

• Assist with database release and take on unblinded monitor duties where applicable.

• Support clinical risk monitoring, audit activities, quality event remediation, and Audit Observation CAPA initiatives.

⛳️ Requirements

• Experience in site management and monitoring for assigned clinical trial investigator sites.

• Familiarity with relevant laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans, and SOPs.

• Capability to manage relationships with investigator sites and oversee clinical trial activities from site initiation to database lock.

• Proficiency in resolving protocol-related challenges, data inquiries, site issues, and implementing corrective/preventive actions.

• Ability to monitor Adverse Events (AEs) and Serious Adverse Events (SAEs).

• Experience managing Trial Master File documentation, site reports, follow-up communications, protocol deviations, recruitment, clinical supplies, study progress, and metrics.

• Knowledge of the product, protocol, and therapeutic area sufficient for discussions with investigators and site teams.

• Ability to support patient safety, eligibility criteria, and clinical guidance.

• Capability to oversee the receipt, handling, accounting, storage, and destruction of investigational products.

• Ability to conduct remote, electronic, and onsite monitoring activities.

• Availability to attend investigator meetings as required, either virtually or in person.

• Ability to work remotely within Poland.

🏝️ Benefits

• Annual bonus: 10%

• Medicover

• Multisport

• Life insurance

• Private pension plan

• Flexible workplace culture that promotes work-life balance

• Reasonable accommodations for disability inclusion