What are the responsibilities and job description for the Clinical Research Associate position at Intellectt Inc?
Job Title: Clinical Research Associate (CRA) - B
Location: Alameda, CA
Duration: 12 Months
Job Description:
We are seeking a motivated Clinical Research Associate (CRA) - B to join our team and support the successful conduct of Phase I-IV clinical trials. The ideal candidate will be responsible for a wide range of clinical trial activities, ensuring adherence to Federal Regulations, ICH guidelines, and the highest quality standards throughout the study lifecycle.
Key Responsibilities:
- Assist senior staff in planning, executing, and managing clinical studies, including developing study protocols and case report forms (CRFs).
- Support the selection and management of Contract Research Organizations (CROs) and investigator sites.
- Train and evaluate investigator sites, ensuring proper protocol adherence and timely patient enrollment.
- Conduct and oversee study monitoring to ensure data accuracy, compliance, and protocol adherence.
- Manage CRF processing, including data cleanup, classification, and retrieval from study sites.
- Organize and run study meetings, and participate in writing and assembling regulatory submissions.
- Ensure the timely completion of study summary reports and provide support in overall study management.
Qualifications:
- 3-5 years of experience as a Clinical Research Associate, with experience in Phase I-IV clinical trials.
- In-depth knowledge of clinical trial processes, GCP, FDA regulations, and ICH guidelines.
- Strong ability to manage multiple tasks, prioritize effectively, and work collaboratively with cross-functional teams.
- Excellent communication, organizational, and problem-solving skills.
- Proficiency in clinical trial management software and Microsoft Office Suite.
