Agency Temporary – CRA II, 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 dedicated Agency Temporary CRA II, Field Monitor to join our clinical research teams.
• • In this pivotal role, you will be instrumental in ensuring the most effective and efficient conduct of clinical research studies, contributing directly to our mission of improving lives and shaping the future through scientific advancement and entrepreneurial spirit.
• • Your responsibilities will encompass a broad spectrum of clinical trial support, including the development, review, and meticulous updating of all study-related training materials and essential documents. This includes crafting site initiation training slides, developing informed consent form templates, authoring procedures manuals, and creating comprehensive laboratory and pharmacy manuals, all to ensure consistent and compliant study execution.
• • You will be tasked with interpreting the intricate medical and scientific intent of assigned study protocols and study procedures, gaining a deep understanding of logistics, potential risks to research subjects, and the methodologies for data evaluation.
• • A key aspect of your role will involve effectively communicating the scientific rationale for assigned studies to both internal team members and external clinical sites, fostering a shared understanding and commitment to the research objectives.
• • You will serve as a Subject Matter Expert for clinical sites, providing expert guidance on protocol interpretation, ensuring accurate understanding of eligibility requirements, and addressing any site-specific queries or challenges.
• • Your involvement will extend to the creation, editing, distribution, and collection of site feasibility questionnaires, playing a crucial role in site selection and readiness.
• • You will oversee and actively support the collection of essential regulatory documents during the critical study start-up phase, ensuring all necessary paperwork is in order for a smooth commencement of research activities.
• • A significant part of your contribution will involve determining the necessary materials and other resources required to conduct the clinical trial, managing their acquisition, and ensuring timely distribution to study sites.
• • You will be responsible for collecting vital study and site metrics, maintaining accurate study trackers to monitor progress and identify potential areas for improvement.
• • A core function will be the thorough review of case report forms (CRFs) and source documents, working collaboratively with clinical sites to resolve any data queries and ensure data integrity.
• • You will maintain regular communication with field Clinical Research Associates (CRAs) to provide essential information before and after site visits, ensuring seamless collaboration and support.
• • You will partner closely with field CRAs and Clinical Trial Assistants (CTAs) to proactively identify and resolve issues that arise during site visits, mitigating potential disruptions to the trial.
• • You will work in tandem with the Supply Chain department to ensure that clinical sites maintain an adequate supply of investigational product (IP), and you will be responsible for resolving any IP temperature monitoring excursions, providing training or assistance to sites with corrective actions.
• • You will be responsible for training vendors, investigators, and study coordinators on specific study requirements and providing ongoing guidance on site-specific issues.
• • Your duties will include conducting clinical specimen log reviews and coordinating the shipment of specimens to the sponsor or contracted vendors, ensuring compliance with all shipping and handling regulations.
• • You will train sites on specimen and shipment requirements for central laboratories and serve as the primary liaison with contracted vendors, facilitating efficient specimen management.
• • You will conduct remote monitoring tasks, including the critical reconciliation of site investigational product accountability, ensuring accurate tracking and control of study materials.
• • You will be involved in providing data listings and compiling clinical study report documents to support medical writing activities, contributing to the final documentation of study outcomes.
• • You will create and/or review presentation materials, such as slides and overheads, for project meetings, departmental reviews, sponsor updates, and business development initiatives.
• • You will provide essential support to the Clinical Trial Manager (CTM) and escalate any significant issues as appropriate, ensuring timely resolution and effective project management.
• • This role offers a unique opportunity to contribute to groundbreaking research within a forward-thinking organization, with the flexibility of remote work and the chance to travel up to 75% to support critical study activities.
• • You will be part of a team dedicated to advancing scientific discovery and improving human health, working within a collaborative and supportive environment.
• • The position requires a proactive approach, strong problem-solving skills, and the ability to manage multiple priorities effectively in a fast-paced research setting.
• • Your contributions will directly impact the successful execution and integrity of clinical trials, ultimately contributing to the development of new therapies and technologies.
• • You will be expected to maintain corporate confidentiality at all times and demonstrate independent decision-making capabilities while also being a strong team player.
• • The role demands a detail-oriented individual with excellent organizational and time management skills, capable of completing projects with reliability and minimal guidance.
• • You will leverage your knowledge of the drug development process and computer literacy in EDC, eTMF, and CTMS systems to ensure efficient study conduct.
• • A solid understanding of ICH E6 and the Code of Federal Regulations is essential for ensuring compliance with global clinical research standards.
• • This temporary agency position offers a competitive hourly rate commensurate with experience and qualifications, providing a valuable opportunity to gain experience within a leading research organization.