Clinical Research Associate

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

📋 Description

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

• Ensure patient safety, the quality of study execution, and adherence to laws, Good Clinical Practices, and Pfizer standards.

• Manage relationships with investigator sites and assist with enrollment, database releases, and site quality.

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

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

• Collaborate with the Site Care Partner on site development, coaching, training, and recruitment efforts.

• Participate in investigator meetings as needed, either virtually or in person.

• Perform remote evaluations of e-diary data.

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

• Monitor site-level adverse events (AEs) and serious adverse events (SAEs) while working with the Drug Safety Unit.

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

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

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

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

• Aid in database release and assume unblinded monitoring responsibilities when applicable.

• Maintain knowledge of the product, protocol, and therapy area while engaging with healthcare professionals.

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

• Facilitate the submission and remediation of Quality Events and support audits and CAPA activities.

⛳️ Requirements

• Comprehension of the product, protocol, and therapy area.

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

• Capability to manage and monitor investigator sites from initiation through database lock and close-out.

• Ability to resolve protocol-related challenges, data queries, and issues at investigator sites.

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

• Skill in managing Trial Master File documentation, site reports, protocol deviations, recruitment tracking, clinical supply management, and study metrics.

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

• Ability to conduct both remote/electronic and onsite monitoring effectively.

• Capacity to support patient safety, eligibility, and clinical guidance.

• Ability to drive Quality Event remediation and develop CAPA for Audit Observations.

• No specific educational credentials or minimum experience requirements indicated.

🏝️ Benefits

• Annual bonus: 10%

• Medicover

• Multisport

• Life insurance

• Private pension plan

• Flexible workplace culture that promotes work-life balance

• Reasonable adjustments for disability inclusion