Senior Clinical Research Associate I

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

📋 Description

• Oversee, monitor, and finalize assigned investigator sites for clinical trials.

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

• Manage operational activities of clinical trials from site initiation to database lock.

• Act as the primary liaison for assigned investigator sites and collaborate with the Site Care Partner and study team.

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

• Coach and educate site personnel on protocols, compliance, patient safety, and operational risks.

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

• Conduct onsite and remote/electronic site initiation, routine monitoring, and closure activities.

• Monitor site-level Adverse Events (AEs) and Serious Adverse Events (SAEs) while working with the Drug Safety Unit.

• Submit necessary documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics.

• Identify, address, and resolve site-related issues, developing corrective and preventative actions as needed.

• Resolve data queries and carry out investigator site close-out tasks.

• Supervise the handling and accountability of investigational products at investigator sites.

• Support database release and take on unblinded monitor responsibilities when necessary.

• Assist study clinicians with patient safety, eligibility criteria, and clinical guidance.

• Lead remediation of Quality Events and oversee audit observation CAPA activities when applicable.

• Mentor and train Clinical Research Associates while participating in process improvement initiatives.

• Execute pre-activation tasks including feasibility assessments, site selection, PTA, coordination of activation checklists, finalization of ICDs, and Site Initiation Visits (SIV).

• Carry out co-monitoring activities upon request.

⛳️ Requirements

• Experience and expertise necessary to manage investigator sites and monitor clinical trials.

• Knowledge of relevant laws, Good Clinical Practices, Pfizer standards, SOPs, and Study Monitoring Plans.

• Familiarity with the product, protocol, and pertinent therapy area.

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

• Proficiency in monitoring adverse events (AEs) and serious adverse events (SAEs).

• Skill in managing clinical trial documentation, including Trial Master File documentation, reports, tracking, and metrics.

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

• Competence in conducting onsite and remote/electronic monitoring.

• Proficiency in supporting patient safety, eligibility, recruitment, database release, and audit/CAPA activities.

• Willingness to mentor and train Clinical Research Associates and act as a Subject Matter Expert (SME) for CRA-related processes.

• Openness to attending investigator meetings, whether virtually or in person.

• Readiness to perform feasibility studies, site selection, site activation, SIV, co-monitoring, and working-group activities as required.

🏝️ Benefits

• Annual bonus: 15%

• Medicover

• Multisport

• Life insurance

• Private pension plan

• Flexible workplace culture fostering work-life balance

• Reasonable accommodations for disability inclusion