What are the responsibilities and job description for the Clinical Research Associate (CRA) II/Senior CRA position at i-Pharm Consulting?
Job Title: Clinical Research Associate (CRA) II/Senior CRA
Job Type: 3-6 Month Contract
Location: United States - Texas
Must Have: Phase 1 Monitoring Experience of Healthy Volunteers
Responsibilities:
- Oversee and manage the progress of clinical trials at investigational sites, ensuring adherence to the study protocol, ICH-GCP, and local regulatory requirements.
- Conduct site initiation, monitoring, and close-out visits, offering continuous support to ensure optimal site performance.
- Establish and maintain strong working relationships with investigators, site staff, and other key stakeholders.
- Ensure accurate and timely collection and reporting of clinical trial data.
- Proactively identify potential risks and work with the study team to resolve issues affecting timelines, data quality, or compliance.
- Provide guidance to junior CRAs and assist in their professional development.
- Ensure all clinical trial documentation is maintained in compliance with regulatory requirements and company SOPs.
Requirements:
- Extensive experience monitoring Phase 1 trials with healthy volunteers.
- Happy to monitor across Texas and the West Coast.
- In-depth knowledge of ICH-GCP, FDA, and other regulatory standards and guidelines.
- Excellent organizational, communication, and problem-solving skills.
- Ability to travel to clinical sites as required by the study.
- A bachelor’s degree in Life Sciences or a related field (or equivalent experience).
If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at schandraratna@i-pharmconsulting.com or call: 44 (0) 2075510732
