What are the responsibilities and job description for the Clinical Research Associate - Sponsor Dedicated position at Preferred Home Health Care & Nursing Services?
Role Overview
The position involves supporting clinical studies across various therapeutic areas as a Clinical Research Associate II (CRA II) or Senior CRA.
Key Responsibilities
The position involves supporting clinical studies across various therapeutic areas as a Clinical Research Associate II (CRA II) or Senior CRA.
Key Responsibilities
- Conduct site monitoring activities including selection, initiation, routine visits, and close-out.
- Ensure compliance with study protocols, GCP, ICH guidelines, and regulatory standards.
- Collaborate with sites to develop and track patient recruitment and retention strategies.
- Provide protocol training and maintain communication with site staff.
- Identify, escalate, and resolve quality and compliance issues.
- Monitor study progress through tracking regulatory submissions, enrollment, and data quality.
- Maintain accurate documentation within TMF and ISF, prepare monitoring reports.
- Support study execution through cross-functional collaboration and potentially assist with start-up activities and financial management.
- Bachelor’s degree in Life Sciences, Healthcare, Nursing, or related field preferred; relevant experience may suffice.
- At least 2 years of independent on-site monitoring experience in the industry.
- Strong knowledge of clinical research processes, GCP, ICH guidelines, and therapeutic areas.
- Proficiency in Microsoft Office and electronic data capture tools.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently and in team settings.