Sr CRA (Poland) - Sponsor-dedicated

📋 Description

• • As a Senior Clinical Research Associate (Sr. CRA) dedicated to a specific sponsor at Syneos Health, you will play a pivotal role in the successful execution of clinical trials, ensuring adherence to the highest standards of quality, regulatory compliance, and ethical conduct.
• • You will be responsible for the comprehensive oversight of clinical investigator sites, performing critical activities such as site qualification, initiation, interim monitoring, site management, and close-out visits. These essential tasks can be conducted either on-site or remotely, providing flexibility and efficiency in trial management.
• • Your expertise will be crucial in evaluating the overall performance of clinical sites and their staff, utilizing your judgment and experience to identify areas for improvement and provide actionable recommendations. You will be empowered to immediately communicate and escalate any serious issues to the project team, collaborating to develop and implement effective action plans.
• • Maintaining a robust understanding of ICH/GCP Guidelines, relevant local regulations, and company Standard Operating Procedures (SOPs) is paramount to ensure all trial activities are conducted in compliance.
• • A key responsibility will be to meticulously verify that the informed consent process has been adequately performed and documented for each study participant, demonstrating a strong commitment to protecting patient rights and confidentiality.
• • You will proactively assess factors that could impact subject safety and the integrity of clinical data at investigator sites, including protocol deviations, violations, and pharmacovigilance issues, taking swift corrective action as needed.
• • In alignment with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will assess site processes, conduct thorough Source Document Reviews (SDR) of medical records, and verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs).
• • You will apply advanced query resolution techniques, both remotely and on-site, providing guidance to site staff to ensure timely closure of data queries, thereby maintaining data integrity.
• • Proficiency in utilizing available hardware and software for effective clinical study data review and capture is expected, including ensuring site compliance with electronic data capture requirements.
• • For investigational products (IP), you will perform inventory, reconciliation, and review storage and security protocols. You will verify that IP has been dispensed and administered to subjects according to the protocol and address any issues or risks associated with blinded or randomized information.
• • You will ensure the Investigator Site File (ISF) is accurate, timely, and complete, reconciling its contents with the Trial Master File (TMF) and confirming the investigator's awareness of essential document archiving requirements.
• • Comprehensive documentation of all activities through confirmation letters, follow-up letters, trip reports, and communication logs, in accordance with SOPs and the CMP/SMP, is a core function.
• • You will actively support subject recruitment, retention, and awareness strategies, and diligently enter data into tracking systems to monitor observations, status, and action items through to resolution.
• • Understanding project scope, budgets, and timelines for your activities and those of the clinical team is essential. You will manage site-level activities and communication to ensure project objectives and deliverables are met, demonstrating the ability to adapt quickly to changing priorities.
• • You may serve as the primary liaison with project site personnel, collaborating with Central Monitoring Associates as needed, and ensuring all assigned sites and project team members are adequately trained and compliant.
• • You will prepare for and attend Investigator Meetings and sponsor face-to-face meetings, and participate in, or potentially lead, global clinical monitoring/project staff meetings, including sponsor representation.
• • Providing guidance on audit readiness standards at the site and project level, and supporting audit preparation and follow-up actions, will be a key contribution.
• • There are opportunities to mentor more junior CRAs, including performing training and sign-off visits for them.
• • You may also be mentored and assigned clinical operations lead tasks under the supervision of an experienced Clinical Operations Lead (COL) or operational line manager.
• • For Real World Late Phase (RWLP) studies, you will adopt the title of Sr. Site Management Associate I and undertake additional responsibilities such as site support throughout the study lifecycle, understanding local RWLP study design requirements, performing chart abstraction, and collaborating with various internal and external stakeholders.
• • You will proactively identify and communicate out-of-scope activities, suggest potential sites based on local knowledge, identify operational efficiencies, develop country-level informed consent forms, and collaborate with regulatory teams.
• • Participation in bid defense meetings is also a possibility within this role.
• • This role requires a proactive, detail-oriented individual with strong communication and problem-solving skills, capable of managing multiple priorities in a dynamic environment.