Systems Ally - Princeton, NJ
posted 3 months ago
The Clinical Research Associate (CRA) 1 position is a contract role based in Princeton, NJ, requiring candidates to be local to the area. This position is not remote and involves significant travel, with expectations of 50% travel within the United States. The CRA will be responsible for various tasks associated with clinical research, including remote monitoring, SOP creation, site selection setup, protocol development, and execution of clinical studies, particularly in the medical device sector. Candidates should have 3 to 6 years of relevant experience, ideally with a background in clinical research from the sponsor side, although CRO experience is also acceptable if the candidate is adaptable and coachable. The role demands a flexible approach, as the CRA will need to wear multiple hats throughout all phases of the study. This includes creating clinical documents such as training materials, protocols, and case report forms (CRFs), as well as participating in data management activities like user acceptance testing (UAT). Knowledge of US regulations and experience with US sites is crucial, as most studies will be conducted in the United States. The CRA will also be expected to lead small groups, communicate effectively, and manage conflicts, especially when representing the client externally. The CRA will support the design, preparation, execution, monitoring, and closure of IVD clinical studies, which are essential for regulatory submissions for new product launches. The position requires strong organizational skills and the ability to work independently while also collaborating with teams. The CRA will be involved in site initiation, data verification, and the closeout of studies, ensuring that all documentation is collected and filed appropriately. This role is critical in ensuring the successful execution of clinical studies and the timely delivery of results.