Sr CRA I - Sponsor dedicated - Argentina Home Based

📋 Description

• • As a Senior Clinical Research Associate (Sr. CRA I) dedicated to a specific sponsor, you will play a pivotal role in ensuring the successful execution of clinical trials within Argentina, operating remotely from your home base.
• • Your primary responsibility will be to conduct comprehensive site qualification, initiation, interim monitoring, site management, and close-out visits. These visits can be performed either on-site or remotely, demanding adaptability and a keen eye for detail.
• • You will rigorously ensure compliance with all relevant regulatory standards, including ICH-GCP (International Council for Harmonisation of Good Clinical Practice) and/or GPP (Good Pharmacoepidemiology Practice), as well as adherence to specific study protocols.
• • Utilizing your professional judgment and extensive experience, you will evaluate the overall performance of clinical trial sites and their staff, identifying areas for improvement and providing actionable recommendations.
• • You will be expected to immediately communicate and escalate any serious issues or concerns to the project team, proactively developing and implementing effective action plans to mitigate risks and ensure data integrity.
• • Maintaining a thorough and up-to-date understanding of ICH/GCP Guidelines, other applicable regulatory guidance, and Syneos Health’s Standard Operating Procedures (SOPs) and processes is crucial for this role.
• • A critical aspect of your role involves verifying that the informed consent process has been adequately performed and documented for each study participant, demonstrating diligence in protecting participant confidentiality at all times.
• • You will assess potential risks to participant safety and the integrity of clinical data at investigator sites, including 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).
• • You will apply effective query resolution techniques, both remotely and on-site, providing guidance to site staff to drive query closure within agreed-upon timelines.
• • Leveraging available hardware and software, you will support the effective conduct of clinical study data review and capture, ensuring compliance with electronic data capture requirements.
• • You may be responsible for investigational product (IP) inventory, reconciliation, and verifying its storage and security, ensuring it has been dispensed and administered to participants according to the protocol.
• • You will also verify any issues or risks associated with blinded or randomized information related to the IP, applying your knowledge of GCP/local regulations and organizational procedures to ensure proper IP handling.
• • Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconciling its contents with the Trial Master File (TMF), will be a key task.
• • You will ensure that investigator sites are aware of and comply with the requirements for archiving essential documents in accordance with local guidelines and regulations.
• • Documenting all activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and the CMP/SMP is essential.
• • You will actively support subject recruitment, retention, and awareness strategies, and enter data into tracking systems to monitor observations, ongoing status, and action item resolution.
• • Understanding project scope, budgets, and timelines for your activities and those of others within the clinical team is vital for managing site-level activities and communication to ensure project objectives and deliverables are met.
• • You must be able to adapt quickly to changing priorities and achieve set goals and targets.
• • You may act as the primary liaison with project site personnel or collaborate with Central Monitoring Associates.
• • Ensuring all assigned sites and project-specific site team members are adequately trained and compliant with applicable requirements is a core responsibility.
• • You will prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
• • Participating in, and potentially leading with supervision, global clinical monitoring/project staff meetings (including sponsor representation) and attending clinical training sessions according to project-specific requirements will be expected.
• • Providing guidance at the site and project level towards audit readiness standards and supporting preparation for audits and required follow-up actions are key contributions.
• • For those with leadership potential, you may provide training or mentorship to more junior CRAs, and potentially perform training and sign-off visits for junior staff.
• • 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 operate under the title of Sr. Site Management Associate I, with additional responsibilities including site support throughout the study lifecycle, knowledge of local RWLP design requirements, chart abstraction, and data collection.
• • You will collaborate with and build relationships with the Sponsor, other affiliates, medical science liaisons, and local country staff, proactively suggesting potential sites based on local knowledge.
• • Identifying operational efficiencies and process improvements, developing country-level informed consent forms, and collaborating with the RWLP Regulatory team to ensure updated regulatory information is applied and shared are also part of the role.
• • You will participate in bid defense meetings, contributing to the company's business development efforts.