Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Less then 1 Year
Description
- CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited and smooth management of clinical trials.
- Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
- collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
- In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
- Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
- Monitoring of investigational sites as per ICH GCP This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
Qualifications
Highest qualification: University
- CRA II: minimum of 6 months of CRA independent monitoring experience
- CRA III: 2+ years of CRA independent monitoring experience
- SCRA: minimum 4+ years of independent monitoring experience