IQVIA combină analiza datelor din domeniul sănătății, tehnologia avansată și serviciile de consultanță pentru a ajuta organizațiile să abordeze provocări complexe din sectoarele științelor vieții și al asistenței medicale. Platforma sa Connected Intelligence reunește date și inteligență artificială pentru a sprijini cercetarea clinică, dezvoltarea tehnologică și progresul unor terapii noi. Echipele companiei lucrează în domeniile analizei datelor, consultanței și tehnologiei medicale, oferind oportunități legate de cercetare, inovare digitală și eforturi de îmbunătățire a rezultatelor pentru pacienți.
Clinical Research Associate, Sponsor Dedicated
Monitor clinical trial sites and support protocol compliance, patient recruitment, and study documentation for IQVIA. Coordinate with site staff and project teams to help trials meet quality standards and milestones.
Descriere
- Monitor sites through selection, initiation, routine visits, and study close-out.
- Assess site performance and compliance with protocols, GCP, ICH guidelines, and regulatory requirements.
- Plan and track patient recruitment and retention with investigative sites.
- Train site staff on study protocols and maintain regular communication.
- Document and escalate quality or compliance issues and support their resolution.
- Track regulatory submissions and approvals, enrollment, CRF completion, and data query resolution.
- Keep Trial Master File and Investigator Site File records complete and accurate.
- Prepare monitoring reports, follow-up letters, and other study documentation.
- Work with project teams across functions to support study delivery and milestones.
- Support study start-up, site budget tracking, financial management, and site payments as needed.
Cerințe
- A bachelor’s degree in life sciences, healthcare, nursing, or a related field is preferred.
- Relevant education and professional experience may be considered instead of a degree.
- At least two years of independent on-site monitoring experience in pharmaceutical, biotechnology, or CRO settings.
- Strong knowledge of clinical research processes and regulations, including GCP and ICH guidelines.
- Industry experience and training in therapeutic areas and clinical trial protocols.
- Proficiency with Microsoft Word, Excel, and PowerPoint, plus mobile and electronic data capture tools.
- Clear verbal and written communication with investigators, site personnel, sponsors, and internal stakeholders.
- Strong organization, problem-solving, and time-management skills.
- Ability to manage multiple priorities in a fast-paced setting.
- Ability to work independently and build collaborative relationships with colleagues, clients, and study teams.
Beneficii
- Health and welfare benefits are available.
- Incentive plans, bonuses, or other forms of compensation may be offered.