Sr CRA I​/II - FSP model - Poland - Homebased

Sr CRA I/II – FSP model – Poland – Home‑based

Job Responsibilities:

• Performs site qualification, initiation, interim monitoring, site management and close‑out visits (on‑site or remote) to ensure compliance with regulatory, ICH‑GCP, Good Pharmacoepidemiology Practices (GPP) and protocol requirements.
• Uses judgment to evaluate overall site performance and staff, recommends site‑specific actions, and promptly communicates/escalates serious issues to the project team with action plans.
• Maintains a working knowledge of ICH/GCP guidelines, other applicable guidance, local regulations, and company SOPs/processes.
• Verifies informed consent procedures are adequately performed and documented for each subject, and protects subject confidentiality.
• Assesses factors that may affect subject safety and data integrity, including protocol deviations, violations and pharmacovigilance issues.
• Assesses site processes and conducts source document reviews to confirm that clinical data entered into the case report form (CRF) is accurate and complete.
• Applies query resolution techniques on‑site and remotely, guiding site staff to close queries within agreed timelines.
• Utilizes hardware and software to support effective study data review and capture, verifying site compliance with electronic data capture requirements.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensing and administration according to protocol.
• Ensures IP is appropriately (re) labelled, imported and released/returned in accordance with GCP/local regulations and organizational procedures.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, and reconciles ISF contents with the Trial Master File (TMF).
• Ensures that investigators are aware of archiving requirements and documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents per SOPs.
• Supports subject recruitment, retention and awareness strategies; tracks all observations and action items using appropriate tracking systems.
• Understands project scope, budgets and timelines, and manages site‑level activities and communication to meet project objectives and deliverables.
• Acts as primary liaison with site personnel and collaborates with Central Monitoring Associates as needed.
• Prepares for and attends investigator meetings and sponsor face‑to‑face meetings; participates in global clinical monitoring/project staff meetings and attends training sessions as required.
• Provides guidance toward audit readiness and supports preparation for audits and required follow‑up actions.
• Mentors and trains junior CRA staff, performs training and sign‑off visits, and may be mentored for lead tasks under experienced Clinical Operations Lead or line manager.
• Participates in business development proposals, bid defense meetings, RFPs, scope and budgeting, and contributes to study and country‑level informed consent forms.
• In Real World Late Phase (RWLP) studies, may support chart abstraction, data collection, collaboration with Regulatory teams, and develop site management strategies.

Qualifications:

• Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent education, training, and experience.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines and other applicable regulatory requirements.
• Demonstrated computer proficiency and willingness to adopt new technologies.
• Excellent communication, presentation and interpersonal skills; moderate critical thinking ability.
• Ability to manage travel of up to 75% of the time on a regular basis.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company also complies with EU Equality Directive obligations related to recruitment and employment.