IQVIA apvieno veselības aprūpes datu analītiku, progresīvas tehnoloģijas un konsultācijas, lai palīdzētu organizācijām risināt sarežģītus izaicinājumus dzīvības zinātņu un veselības aprūpes nozarēs. Tās Connected Intelligence platforma apvieno datus un mākslīgo intelektu, lai atbalstītu klīniskos pētījumus, tehnoloģiju izstrādi un jaunu terapiju attīstību. Uzņēmuma komandas strādā analītikas, konsultāciju un veselības aprūpes tehnoloģiju jomā, piedāvājot iespējas, kas saistītas ar pētniecību, digitālo inovāciju un pacientu ārstēšanas rezultātu uzlabošanu.
Clinical Research Associate, Sponsor-Dedicated — IQVIA, Overland Park Onsite
Monitor clinical trial sites, recruitment, compliance, and study documentation for IQVIA’s sponsor-dedicated research programs. Support study operations and project delivery from start-up through close-out.
Apraksts
- Conduct site selection, initiation, monitoring, and close-out visits.
- Coordinate with sites to implement, advance, and monitor subject recruitment plans.
- Deliver protocol and study training to assigned sites.
- Maintain regular site communication to manage expectations and resolve issues.
- Assess site practices for protocol quality, data integrity, and regulatory compliance.
- Escalate quality concerns through appropriate channels.
- Monitor regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query creation and resolution.
- Assist with study start-up activities when required.
- Confirm that site documents are ready for Trial Master File filing.
- Verify Investigator Site File maintenance against GCP, ICH, and applicable local regulations.
- Prepare and maintain site management records, monitoring findings, and action plans.
- Submit monitoring visit reports, follow-up letters, and other required study documents.
- Work with study team members to advance project execution.
- Help create site-specific subject recruitment plans when applicable.
- Assist with site financial administration and collect invoices in line with local requirements when applicable.
Prasības
- A bachelor’s degree in a scientific or healthcare discipline is preferred.
- An equivalent combination of education, training, and experience may be accepted instead of a degree.
- Some organizations may require completion of a CRA training program or previous monitoring experience.
- Basic understanding of clinical research regulations, including GCP and ICH guidelines.
- Working knowledge of therapeutic areas and protocols gained through company training.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Ability to use a laptop, iPhone, and iPad where applicable.
- Strong written and verbal communication skills with good command of English.
- Effective organizational and problem-solving abilities.
- Effective time and financial management skills.
- Ability to build and maintain productive relationships with coworkers, managers, and clients.
Priekšrocības
- Incentive plans, bonuses, or other compensation may be available.
- Health and welfare benefits may be available.
- Additional benefits may be available.