Senior Clinical Research Associate
Company: OnSite Research, Inc.
- Location: New York City, United States
- Seniority: Senior
- Employment type: Contract
- Posted: 7 days ago
- Offer language: English
Job description
Company Description OnSite Research, Inc. is a specialty Contract Research Organization (CRO) focused on providing immediate-need staffing and clinical trial management solutions. The company partners with small to mid-sized pharmaceutical and medical device organizations, helping them advance innovative therapies and technologies. OnSite Research, Inc. offers flexible, tailored services that address urgent project demands and evolving study requirements while navigating regulatory requirements. Team members collaborate closely with sponsors to deliver high-quality, compliant clinical research outcomes.
Role Description The Senior Clinical Research Associate (CRA) contract role is responsible for overseeing the day-to-day monitoring and facilitation of clinical trials in a remote capacity and at assigned investigative sites. This includes establishing and maintaining productive communication with site staff, conducting site initiation, routine monitoring, and close-out visits, ensuring adherence to study protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and regulatory requirements. The Senior CRA will review source documentation and case report forms for accuracy and completeness, identify and resolve data discrepancies, and provide guidance to site staff on protocol compliance. Additional responsibilities include contributing to risk assessment and mitigation plans, supporting study start-up activities, preparing monitoring reports, and collaborating with clinical operations and project management teams to maintain timelines and quality standards.
Qualifications
- Strong clinical trials knowledge, including experience with study design, execution, and monitoring in Phase I–IV clinical research.
- Proficiency in protocol review and implementation, with the ability to interpret and apply protocol requirements at investigative sites.
- Experience working as a Clinical Research Associate, including independent on-site and remote monitoring of investigative sites.
- Background in clinical operations, including site management, feasibility, start-up, and coordination with cross-functional study teams.
- Solid research skills, including data review, documentation, and adherence to GCP, ICH guidelines, and relevant regulatory standards.
- Bachelor’s degree in a life science, nursing, pharmacy, or related field (or equivalent relevant experience).
- 10 years of CRA experience, preferably in a Senior or Lead CRA capacity within pharma, device, or CRO environments.
- Excellent written and verbal communication skills, with strong attention to detail and organizational capabilities.
- Ability to work independently in a remote setting, manage multiple studies and sites, and meet contract-based project deadlines.
- Comfort with electronic data capture (EDC) systems, CTMS tools, and remote monitoring technologies.
