Description
Join IQVIA as a Clinical Research Associate, playing a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements.
Key Responsibilities:
- Conduct site monitoring visits in line with GCP and ICH guidelines, including selection, initiation, monitoring, and close-out visits.
- Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
- Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
- Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
- Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution.
- Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local regulations.
- Generate visit reports, follow-up letters, and other necessary documentation.
- Mentor clinical staff through co-monitoring and training visits.
- Work closely with study team members to support project execution.
Qualifications:
- BS degree required; a degree in a scientific discipline or healthcare is preferred.
- 3+ years of on-site oncology monitoring experience strongly preferred; 1.5+ years of oncology monitoring experience can be considered.
- Phase 1 oncology experience is required.
Skills:
- Proficient in GCP and ICH guidelines.
- Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
- Excellent computer skills, including Microsoft Office and mobile devices.
- Effective communication, organizational, and problem-solving abilities.
- Strong time management skills.
- Ability to build and maintain effective working relationships.
Why Join Us? Be part of a team that's pushing the boundaries of cancer research, working on cutting-edge Phase 1 oncology trials, collaborating with top professionals, and contributing to life-changing advancements in cancer treatment.
The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00.