Clinical Research Associate

$99,840 - $104,000/Yr

Systems Ally - Princeton, NJ

Full-time - Entry Level

Onsite - Princeton, NJ

About the position

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.

Responsibilities

• Conduct remote monitoring of clinical sites to ensure compliance with study protocols and regulatory requirements.
• Create and review clinical documents including protocols, training materials, and case report forms (CRFs).
• Participate in user acceptance testing (UAT) and data management activities.
• Support the preparation and execution of study site initiations, including document collection and training module generation.
• Lead and manage the closeout of clinical studies, ensuring all documentation is collected and filed appropriately.
• Interact with clinical sites to ensure proper execution of studies and address any issues that arise during the study.
• Provide updates to management regarding study progress and site performance.
• Support the creation of the clinical trial master file and associated documentation.

Requirements

• Bachelor's degree or equivalent experience in a science or medically-related field.
• 3-6 years of experience in clinical research associate tasks such as remote monitoring, SOP creation, and protocol development.
• Experience in the medical device industry is preferred.
• Knowledge of US regulations and experience with US clinical sites is essential.
• Strong communication skills, both oral and written, with the ability to present information effectively.
• Ability to work independently and as part of a team, demonstrating flexibility and adaptability.

Nice-to-haves

• Experience with user acceptance testing (UAT) and data management activities.
• Previous experience working on sponsor-initiated clinical studies.
• Familiarity with International Harmonized/Committee Good Clinical Practices (IHC/GCP) and Current Good Manufacturing Practice (21 CFR Part 820).
• Experience in training and onboarding new clinical research associates.

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance