Senior Clinical Research Associate

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

📋 Description

• Oversee, supervise, and finalize activities at designated clinical trial investigator sites.

• Ensure adherence to the Study Monitoring Plan, relevant legislation, Good Clinical Practices, and Pfizer's standards during clinical trial execution.

• Manage the operational implementation of clinical trial processes from site initiation to database lock.

• Act as the primary liaison for assigned investigator sites throughout the study.

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

• Conduct development, coaching, and training for site personnel.

• Attend investigator meetings as necessary, whether virtually or in person.

• Assist with enrollment and address site activation and recruitment challenges.

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

• Supervise site-level adverse events (AEs) and serious adverse events (SAEs), following up with investigators to address reporting issues.

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

• Identify and troubleshoot issues at investigator sites, developing corrective and preventive actions.

• Resolve data queries and prepare for site close-out activities.

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

• Provide support for database release as required.

• Undertake unblinded monitoring responsibilities as needed.

• Maintain knowledge of products, protocols, and therapy areas while interacting with healthcare professionals.

• Assist the study clinician with patient safety, eligibility, and clinical guidance.

• Drive the remediation of Quality Events and support audits and CAPA activities when necessary.

• Mentor and train Clinical Research Associates.

• Act as a subject matter expert (SME) for CRA-related processes.

• Engage in regional or local working groups and process improvement initiatives.

• Carry out pre-activation activities including feasibility, site selection, PTA, coordination of activation checklists, ICD finalization, and SIV.

• Execute co-monitoring activities as requested.

⛳️ Requirements

• Proven experience and capability in site management, monitoring, and close-out of assigned clinical trial investigator sites.

• Familiarity with applicable laws, Good Clinical Practices, and Pfizer standards.

• Proficiency in managing relationships with investigator sites and ensuring clinical trial success.

• Competence in resolving protocol-related challenges.

• Ability to perform onsite and remote/electronic monitoring effectively.

• Skills in monitoring AEs and SAEs and collaborating with the Drug Safety Unit.

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

• In-depth understanding of the product, protocol, and therapeutic area.

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

• Capacity to lead Quality Event remediation and develop and check Audit Observation CAPAs when applicable.

• Ability to mentor and train Clinical Research Associates.

• Expertise to act as an SME for CRA-related processes.

• Skills to conduct feasibility studies, site selection, PTA, coordination of site activation checklists, ICD finalization, and SIV activities under the guidance of a Site Care Partner.

• Ability to carry out co-monitoring activities as needed.

🏝️ Benefits

• Annual bonus of 15%.

• Medicover.

• Multisport membership.

• Life insurance coverage.

• Private pension plan.

• Additional corporate benefits in accordance with Pfizer Pay Policy.

• Flexible workplace culture that promotes work-life balance.

• Reasonable accommodations for disability inclusion.