Agency Temporary-Senior CRA, Field Monitor

📋 Description

• • NantWorks, LLC, a dynamic parent company at the forefront of innovation across life sciences, energy & renewables, and media & technology, is seeking a highly skilled and experienced Agency Temporary-Senior CRA, Field Monitor to join their clinical research teams. This pivotal role is designed to ensure the most effective and efficient conduct of clinical research studies by providing comprehensive training, expert protocol interpretation, meticulous document collection and review, and robust overall clinical trial support. As a Senior CRA, you will be instrumental in upholding the integrity and success of critical research initiatives that aim to improve lives and shape the future.
• • Your responsibilities will encompass the development, review, and updating of all study-related training materials and essential documents. This includes crafting compelling site initiation training slides, developing clear and compliant informed consent form templates, and creating detailed procedures manuals, as well as laboratory and pharmacy manuals. Your expertise will ensure that all study personnel are thoroughly equipped with the necessary knowledge and resources.
• • A core aspect of this role involves interpreting the complex medical and scientific intent of assigned study protocols and study procedures. You will analyze logistics, assess risks to research subjects and safety, and understand data evaluation methods. This deep understanding will be crucial in communicating the scientific rationale for assigned studies effectively to both internal team members and external clinical sites, fostering a shared vision and commitment to the research objectives.
• • You will serve as a Subject Matter Expert for clinical sites, offering invaluable guidance on protocol interpretation and eligibility requirements. This proactive support helps to streamline patient recruitment and ensure adherence to study protocols, minimizing deviations and maximizing data quality.
• • The role also includes the creation, editing, distribution, and collection of site feasibility questionnaires, playing a key role in the early stages of study planning and site selection. You will oversee and support the collection of essential documents during the critical study start-up phase, ensuring all regulatory and operational requirements are met before patient enrollment begins.
• • You will be responsible for collecting study and site metrics, maintaining study trackers, and actively participating in case report form (CRF) data review. This involves reviewing source documents and collaborating with sites to resolve data queries efficiently, ensuring the accuracy and completeness of the trial data.
• • Regular communication with both field and in-house Clinical Research Associates (CRAs) is essential. You will provide critical information before and after site visits, and partner closely with field CRAs to resolve any issues identified during their site monitoring activities, ensuring a cohesive and responsive approach to site management.
• • A key responsibility involves working with the Supply Chain team to ensure sites maintain sufficient investigational product (IP) for the trial's duration. You will also be tasked with resolving IP temperature monitoring excursions and providing training or assistance to sites on implementing corrective actions, safeguarding product integrity.
• • You will train vendors, investigators, and study coordinators on specific study requirements and provide expert guidance on site-specific issues, ensuring consistent application of study procedures across all participating sites.
• • Additional duties include clinical specimen log review, coordinating the shipment of specimens to the sponsor or contracted vendors, and conducting remote monitoring tasks such as reconciling site investigational product accountability as needed. Furthermore, you will provide mentorship and training to newly hired research staff, contributing to the development of the clinical research team.
• • This temporary role offers a unique opportunity to contribute to groundbreaking research within a forward-thinking organization, leveraging your extensive experience to drive clinical trial excellence and support NantWorks' mission to change mankind for the better.