Clinical Research Associate
Company: CareerUS Solutions Agency
- Location: United States
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Job Summary
We are seeking a detail-oriented and experienced Clinical Research Associate (CRA) to monitor and manage clinical trials, ensuring compliance with clinical research protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The ideal candidate will have experience in clinical trial monitoring, site management, documentation, and regulatory compliance.
Key Responsibilities
- Monitor clinical trial sites to ensure compliance with study protocols and regulatory requirements.
- Conduct site initiation, routine monitoring, and close-out visits.
- Ensure clinical studies follow Good Clinical Practice (GCP) guidelines.
- Review clinical trial documentation and source data.
- Verify the accuracy and completeness of clinical trial data.
- Identify, document, and resolve protocol deviations.
- Maintain communication with investigators, clinical research coordinators, and study teams.
- Prepare monitoring visit reports and maintain study documentation.
- Ensure patient safety and confidentiality throughout clinical trials.
- Support regulatory inspections and audits.
- Track study progress, enrollment, and site performance.
Required Skills
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related field.
- Knowledge of Good Clinical Practice (GCP) guidelines.
- Understanding of FDA regulations and clinical research processes.
- Experience with clinical trial documentation and site monitoring.
- Knowledge of clinical trial management systems (CTMS).
- Familiarity with Electronic Data Capture (EDC) systems.
- Strong communication and organizational skills.
- Excellent attention to detail and problem-solving abilities.
Preferred Qualifications
- Experience with Phase I, II, III, or IV clinical trials.
- Knowledge of FDA 21 CFR Part 11 requirements.
- Experience with Medidata Rave, Oracle Clinical, or similar EDC platforms.
- ACRP or SOCRA certification is a plus.
- Experience working with CROs or pharmaceutical companies.
- Knowledge of regulatory submissions and clinical trial audits.
