Meena J Huh
- Role
- Clinical Research Associate Ii at IQVIA
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
Experience
Clinical Research Associate Ii
Oct 2022 — Present
Perform site selection, initiation, monitoring, and close-out visits in accordance with good clinical practice. • Accountable for supporting the development of project subject recruitment plan on a per-site basis. Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability. • Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation. • Build awareness of features and opportunities of study to site. • Collaborate and liaise with study team members for project execution support as appropriate.
Skills
- Customer Service
- Microsoft Office
- Public Speaking
- Event Planning
- Social Media
- Leadership
- Healthcare
- Powerpoint
- Teamwork
- Microsoft Excel
- Research
- Microsoft Word
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