Clinical Research Associate II, Field Monitor

📋 Description

• • As a Clinical Research Associate II (CRA II) with a focus on Field Monitoring at NantWorks, LLC, you will be instrumental in ensuring the integrity, accuracy, and efficiency of clinical research studies. You will serve as a critical liaison between clinical sites, internal teams, and regulatory bodies, upholding the highest standards of Good Clinical Practice (GCP) and protocol adherence.
• • Your primary responsibility will involve providing comprehensive support to clinical research teams, encompassing training, protocol interpretation, meticulous document collection and review, and overall clinical trial management. This role demands a deep understanding of the scientific and medical intent behind study protocols to effectively guide and support research sites.
• • You will be tasked with developing, reviewing, and updating essential study-related training materials. This includes crafting site initiation training slides, developing informed consent form templates, and creating detailed procedures manuals, as well as laboratory and pharmacy manuals to ensure consistent and compliant study conduct across all participating sites.
• • A key aspect of your role will be to interpret the medical and scientific rationale of assigned study protocols. This involves understanding study procedures, logistical considerations, potential risks to research subjects, and the methods for data evaluation, enabling you to provide expert guidance.
• • You will act as a Subject Matter Expert (SME) for clinical sites, offering clear and concise guidance on protocol interpretation, patient eligibility requirements, and study-specific procedures. This expertise is crucial for maintaining the quality and validity of the data collected.
• • The role includes creating, editing, distributing, and collecting site feasibility questionnaires to identify and select appropriate sites for clinical trials, ensuring a strong network of capable research partners.
• • You will oversee and support the collection of essential regulatory documents during the study start-up phase, ensuring all necessary paperwork is in order before patient enrollment begins.
• • You will be responsible for determining the materials and resources required to conduct the clinical trial, managing their acquisition, and ensuring timely distribution to clinical sites.
• • Collecting and maintaining study and site metrics, along with managing study trackers, will be essential for monitoring study progress and identifying areas for improvement.
• • A significant part of your duties will involve conducting case report form (CRF) data review and source document verification. You will collaborate closely with clinical sites to resolve data queries, ensuring the accuracy and completeness of the trial data.
• • You will communicate regularly with field Clinical Research Associates (CRAs) to provide critical information before and after site visits, ensuring seamless coordination and support.
• • Partnering with field CRAs and Clinical Trial Assistants (CTAs) to address and resolve issues identified during site visits is paramount to maintaining study momentum and compliance.
• • You will work closely with the Supply Chain department to ensure sites maintain adequate investigational product (IP) inventory and to resolve any IP temperature monitoring excursions. This includes training and assisting sites with corrective actions to maintain product integrity.
• • Training vendors, investigators, and study coordinators on specific study requirements and providing ongoing guidance on site-specific issues will be a regular responsibility.
• • You will conduct clinical specimen log reviews and coordinate the shipment of specimens to the sponsor or contracted vendors, ensuring proper handling and tracking.
• • Training sites on specimen collection and shipment requirements for central laboratories, and serving as a liaison with contracted vendors, will be vital for accurate diagnostic and safety testing.
• • Performing remote monitoring tasks, including the reconciliation of site investigational product accountability, will be a key component of your field monitoring responsibilities.
• • You will provide data listings and compile clinical study report documents to support medical writing activities, contributing to the overall documentation of study findings.
• • Creating and/or reviewing presentation materials, such as slides and overheads, for project, departmental, sponsor, and business development presentations will be required.
• • You will provide essential support to the Clinical Trial Manager (CTM) and escalate issues as appropriate, ensuring timely resolution and effective project management.
• • This role offers the opportunity to contribute to groundbreaking research in oncology and infectious diseases, working with a passionate team dedicated to improving patient lives. Your efforts will directly impact the success of clinical trials that aim to conquer cancer and infectious diseases through innovative immunotherapies.
• • You will be part of a dynamic, commercial-stage biotechnology company that is at the forefront of developing cutting-edge cell and immunotherapy products. This is a chance to join a publicly traded company with significant growth potential and opportunities for professional development.
• • The remote nature of this position allows for flexibility in work hours and location, enabling you to manage your workload effectively across different time zones while maintaining a strong connection with your team and study sites.
• • You will engage with a collaborative environment where cross-functional teamwork is encouraged, providing exposure to various aspects of the company's operations and research initiatives.
• • Your contributions will be recognized and valued, with opportunities for career advancement within a rapidly expanding organization committed to scientific excellence and patient well-being.