FSP CRA II/ Snr CRA

📋 Description

• • As a Functional Service Provider (FSP) Clinical Research Associate II (CRA II) or Senior CRA (Snr CRA) at Syneos Health, you will play a pivotal role in ensuring the successful execution of clinical trials by meticulously monitoring investigator sites. This position is crucial for accelerating the delivery of life-changing therapies by upholding the highest standards of data integrity, patient safety, and regulatory compliance.
• • You will be responsible for conducting comprehensive site qualification, initiation, interim monitoring, site management, and close-out visits. These visits can be performed either on-site at the investigator location or remotely, leveraging technology to maintain oversight. Your primary objective during these visits is to ensure strict adherence to regulatory requirements, ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice), GPP (Good Pharmacoepidemiology Practice), and the specific study protocol.
• • A key aspect of your role involves exercising sound judgment and experience to evaluate the overall performance of investigator sites and their staff. You will identify any potential issues or risks, immediately communicate serious concerns to the project team, and proactively develop and implement effective action plans to mitigate them. Maintaining a thorough understanding of ICH/GCP guidelines, relevant local and international regulations, and Syneos Health’s Standard Operating Procedures (SOPs) and processes is paramount.
• • You will diligently verify that the informed consent process has been adequately performed and documented for every participant, demonstrating a strong commitment to protecting subject confidentiality. Your vigilance will extend to assessing factors that could impact patient safety and the integrity of clinical data, such as protocol deviations, violations, and pharmacovigilance issues.
• • In accordance with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will assess site processes, conduct thorough Source Document Reviews (SDR) of relevant medical records, and verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs) against these source documents. You will apply effective query resolution techniques, both remotely and on-site, providing guidance to site staff to ensure timely closure of data queries.
• • You will utilize available hardware and software tools to support efficient clinical study data review and capture, ensuring compliance with electronic data capture (EDC) requirements. This includes verifying the proper handling, storage, and reconciliation of investigational product (IP), ensuring it is dispensed and administered to participants according to the protocol and that any issues related to blinded or randomized information are addressed.
• • Maintaining the Investigator Site File (ISF) for accuracy, timeliness, and completeness is a critical responsibility. You will reconcile ISF contents with the Trial Master File (TMF) and ensure that investigator sites are aware of and comply with local guidelines and regulations for essential document archiving.
• • Your role involves documenting all activities meticulously through confirmation letters, follow-up letters, trip reports, and communication logs, adhering strictly to SOPs and the CMP/SMP. You will actively support subject recruitment, retention, and awareness strategies, and utilize tracking systems to monitor observations, status, and action item resolution.
• • You will manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met, demonstrating an understanding of project scope, budgets, and timelines. Adaptability to changing priorities to achieve goals and targets is essential.
• • You may serve as the primary liaison with project site personnel, collaborating with Central Monitoring Associates as needed. Ensuring all assigned sites and project-specific site team members receive appropriate training and remain compliant with applicable requirements is key.
• • Preparation for and attendance at Investigator Meetings and sponsor face-to-face meetings are expected. You will participate in, and potentially lead (with supervision), global clinical monitoring and project staff meetings, including sponsor representation, and attend clinical training sessions as required by project specifications.
• • You will provide guidance at both the site and project level to uphold audit readiness standards and support preparation for audits, including managing required follow-up actions.
• • For more junior CRAs, you may provide training and mentorship, potentially performing training and sign-off visits. You might also be mentored and assigned clinical operations lead tasks under the supervision of an experienced Clinical Operations Lead (COL) or operational line manager.
• • In Real World Late Phase (RWLP) studies, you will operate under the title of Sr. Site Management Associate I, providing site support throughout the study lifecycle, possessing knowledge of local requirements for RWLP study designs, conducting chart abstraction, and collaborating with various stakeholders including sponsors, affiliates, medical science liaisons, and local country staff.
• • 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 the RWLP Regulatory team to ensure updated regulatory information is applied and shared. Participation in bid defense meetings is also a component of this role.