What are the responsibilities and job description for the Contract Clinical Research Associate position at OnSite Research, Inc.?
Company Description OnSite Research, Inc. is a specialty clinical research organization (CRO) focused on providing immediate-need staffing and trial management solutions. The company partners primarily with small to mid-sized pharmaceutical and medical device organizations to support their clinical development programs. OnSite Research, Inc. offers flexible, responsive services designed to accelerate study timelines and maintain high-quality standards. Team members collaborate with sponsors, CROs and sites to ensure efficient, compliant, and patient-centered clinical trial execution.
Role Description The Contract Clinical Research Associate (CRA) will support the monitoring and management of clinical trials across assigned study sites in the South Central United States. This remote role involves conducting site qualification, initiation, routine monitoring, and close-out visits; reviewing source data; and verifying data accuracy and protocol compliance. The CRA will oversee site performance, ensure adherence to protocols, regulatory requirements and Good Clinical Practice (GCP), and promptly document and follow up on findings, deviations, and action plans. Day-to-day responsibilities include maintaining study documentation, communicating regularly with site staff and sponsor representatives, supporting query resolution, and contributing to risk-based monitoring activities. This is a contract role, offering project-based assignments with potential variation in workload based on study needs.
Qualifications
- Must have 4 years of Contract Clinical Research Associate experience.
- Ophthalmology and Oncology experience is required.
- 50% travel is required.
- Demonstrated proficiency with clinical trial protocols and the ability to apply protocol requirements consistently across study sites.
- Experience working as a Clinical Research Associate with responsibility for on-site and remote monitoring activities.
- Hands-on experience in clinical trials, including data review, source data verification, and oversight of site compliance.
- Background in clinical operations, including coordination with cross-functional teams and understanding of trial timelines and deliverables.
- Strong knowledge of ICH-GCP, FDA regulations, and applicable international and local regulatory requirements.
- Excellent written and verbal communication skills, with the ability to build effective relationships with site staff and sponsor teams.
- High attention to detail, strong organizational skills, and ability to manage multiple sites or studies remotely.
- Proficiency with electronic data capture (EDC) systems and common clinical trial management tools.
- Bachelor’s degree in a life science, nursing, pharmacy, or related field; advanced degree or relevant certifications (e.g., ACRP, SOCRA) are an asset.
- Previous experience in small to mid-sized pharma, CRO or device studies and comfort working in a fast-paced, contract-based environment.