Senior Clinical Research Associate II

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

📋 Description

• Oversee, monitor, and finalize activities at assigned clinical trial investigator sites.

• Ensure that clinical trials adhere to the Study Monitoring Plan, relevant regulations, Good Clinical Practices, and Pfizer's standards.

• Manage operational elements of trial activities from the initiation of sites to database lock.

• Act as the primary liaison for assigned investigator sites and enhance communication between study teams, vendors, and sites.

• Develop, coach, and train site personnel on compliance with protocols and safeguarding patients.

• Assist with initiatives focused on site enrollment and recruitment.

• Carry out onsite and remote/electronic monitoring for site initiation, routine oversight, and closure.

• Track adverse events and serious adverse events, collaborating with the Drug Safety Unit.

• Prepare and submit necessary reports, documentation, updates, and tracking, including Trial Master File records and site reports.

• Identify and address issues at sites and implement corrective and preventive actions.

• Resolve data queries and perform site closure activities.

• Supervise the handling and accountability of investigational products.

• Aid in database release and conduct unblinded monitoring when necessary.

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

• Drive remediation of Quality Events and corrective action plan (CAPA) activities during audits when applicable.

• Mentor and train Clinical Research Associates (CRAs) and act as a subject matter expert (SME) on CRA processes.

• Engage in or lead initiatives aimed at process improvement.

• Perform Site Care Partner responsibilities for smaller projects or under supervision on larger ones.

• Conduct co-monitoring activities.

⛳️ Requirements

• Experience and capability in managing and monitoring investigator sites for assigned clinical trials.

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

• Ability to ensure adherence to relevant laws, Good Clinical Practices, Pfizer standards, Study Monitoring Plans, and SOPs.

• Competence in managing site initiation, routine monitoring, recruitment, database lock, and closure activities.

• Capacity to monitor and resolve site-level adverse events (AEs) and serious adverse events (SAEs).

• Proficiency in managing Trial Master File documentation, site reports, protocol deviations, recruitment, clinical supplies, study progress, and metrics.

• Ability to identify and resolve site issues while developing corrective and preventive actions.

• Skill in overseeing the receipt, handling, accounting, storage, and destruction of investigational products.

• Capability to support patient safety, eligibility, and provide clinical guidance to investigators.

• Ability to conduct audit support and develop/check corrective action plans (CAPA).

• Experience in mentoring and training CRAs and acting as an SME for CRA-related processes.

• Ability to participate in or lead global, regional, or local working groups and initiatives for process improvement.

• Willingness to assume Site Care Partner responsibilities as needed.

• Ability to conduct co-monitoring activities.

🏝️ Benefits

• Annual bonus: 15%

• Medicover

• Multisport

• Life insurance

• Private pension plan

• Flexible workplace culture that supports work-life harmony

• Reasonable adjustments for disability inclusion