CRA II - FSP - Homebased in Romania

📋 Description

• • As a Clinical Research Associate II (CRA II) with 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 patient safety. This home-based position, operating remotely within Romania, offers the opportunity to contribute to groundbreaking pharmaceutical solutions from the comfort of your own environment.
• • Your primary responsibility will involve conducting comprehensive site monitoring activities, encompassing site qualification, initiation, interim monitoring, site management, and close-out visits. These crucial assessments will be performed either on-site or remotely, requiring a keen eye for detail and the ability to evaluate the overall performance of clinical trial sites and their staff.
• • You will be instrumental in ensuring that all activities are conducted in strict accordance with regulatory guidelines, including ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice) and/or GPP (Good Pharmacoepidemiology Practice), as well as the specific study protocol.
• • A core aspect of your role will be to identify and immediately communicate or escalate any serious issues to the project team, proactively developing robust action plans to mitigate risks and ensure the integrity of the trial.
• • You will maintain a thorough and up-to-date understanding of ICH/GCP Guidelines, relevant national and international regulations, and Syneos Health’s Standard Operating Procedures (SOPs) and processes, ensuring continuous compliance.
• • A critical duty involves verifying that the informed consent process has been adequately performed and documented for each subject, demonstrating a profound respect for patient rights and confidentiality.
• • You will assess factors that could potentially impact subject safety and the integrity of clinical data, such as protocol deviations, violations, and pharmacovigilance issues, taking swift and appropriate action.
• • In alignment with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will meticulously assess site processes, conduct 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 be adept at applying query resolution techniques both remotely and on-site, providing essential guidance to site staff to drive query closure within agreed-upon timelines, utilizing available technology to support efficient data review and capture.
• • Verification of investigational product (IP) inventory, reconciliation, storage, and security will be part of your responsibilities, ensuring the IP has been dispensed and administered to subjects according to the protocol and that any issues related to blinded or randomized information are addressed.
• • 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 understanding of essential document archiving requirements.
• • Documentation of all activities will be meticulously maintained 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 diligently enter data into tracking systems to monitor the status of observations, ongoing activities, and assigned action items through to resolution.
• • Understanding project scope, budgets, and timelines will be essential as you manage site-level activities and communication to ensure project objectives and deliverables are met, demonstrating adaptability to changing priorities.
• • You may serve as the primary liaison with study site personnel, collaborating with Central Monitoring Associates where applicable, and ensuring all assigned sites and project-specific team members are adequately trained and compliant.
• • Preparation for and attendance at Investigator Meetings and sponsor face-to-face meetings will be required, alongside participation in global clinical monitoring/project staff meetings and clinical training sessions.
• • You will contribute to audit readiness standards at the site and project level, supporting preparation for audits and subsequent follow-up actions.
• • For Real World Late Phase studies, you will adopt the title of Site Management Associate II, supporting the study lifecycle from identification through close-out, possessing knowledge of local requirements for real-world late-phase study designs, and potentially conducting chart abstraction activities.
• • Collaboration with Sponsor affiliates, Medical Science Liaisons, and local country staff will be integral, and you may be requested to train junior staff, identifying and communicating out-of-scope activities, and proactively suggesting potential sites based on local knowledge.
• • This role demands a proactive approach, a commitment to quality, and the ability to work independently while being a valuable part of a global team dedicated to accelerating the delivery of life-changing therapies.