Clinical Research Associate
Company: Virtue America Agency
- Location: United States
- Work mode: Remote
- Seniority: Entry level
- Employment type: Contract
- Posted: 2 days ago
- Offer language: English
Job description
Job Title : Clinical Research Associate (CRA) – Entry Level
Location: Remote
Employment Type: Contract
Experience: 0–2 Years
Job Summary
We are seeking a motivated Entry-Level Clinical Research Associate (CRA) to support clinical trial monitoring and site management activities. The ideal candidate will have a background in Pharmacy, Life Sciences, Nursing, Biotechnology, or Clinical Research, with a basic understanding of clinical trial processes and regulatory requirements.
Key Responsibilities
- Support clinical trial site initiation, monitoring, and closeout activities.
- Assist with reviewing clinical trial documentation for accuracy and completeness.
- Monitor clinical trial sites to ensure compliance with study protocols and regulatory requirements.
- Verify informed consent forms, source documents, and case report forms (CRFs).
- Support Investigator Site File (ISF) and Trial Master File (TMF) maintenance.
- Identify protocol deviations and assist with follow-up and resolution.
- Coordinate with clinical investigators, site staff, and study teams.
- Prepare monitoring visit reports and maintain accurate study documentation.
- Ensure compliance with ICH-GCP, FDA regulations, and company SOPs.
Required Qualifications
- Bachelor's degree in Pharmacy, Pharm.D, Nursing, Life Sciences, Biotechnology, or a related field.
- 0–2 years of experience in clinical research, clinical trial coordination, or a related field.
- Basic understanding of clinical trial phases and research processes.
- Knowledge of ICH-GCP guidelines and FDA clinical research regulations.
- Familiarity with informed consent, CRFs, clinical trial documentation, and patient safety reporting.
- Strong communication, organizational, and documentation skills.
- Willingness to travel to clinical research sites as required.
