Senior Clinical Research Associate

Responsibilities

• Manage monitoring functions for Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies.
• Conduct site visits including pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV).
• Serve as the primary CTI contact for assigned study sites and oversee study start-up activities.
• Collect, review, and track essential regulatory documents and manage ISF and TMF in accordance with SOPs.
• Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials.
• Implement subject enrollment strategies and perform remote monitoring activities.
• Identify site issues and implement corrective and preventive actions (CAPA).
• Function as a Lead CRA or mentor/trainer for other CRAs as required.

Requirements

• At least 3 years of clinical trial monitoring experience.
• Bachelor's Degree or higher in an allied health field (e.g., nursing, pharmacy, or health/natural science).
• Experience conducting clinical research studies in a hospital or pharmaceutical setting.
• Strong knowledge of ICH/GCP regulations and relevant regulatory guidelines.

Benefits

• Career advancement through structured mentoring programs and leadership courses.
• Ongoing education support via tuition reimbursement and a dedicated training department.
• Generous health benefits and vacation packages.
• Paid parental leave and hybrid work-from-home opportunities.
• Participation in the unique CTI Cares program.

About the Company

CTI Clinical Trial and Consulting Services is a global, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the entire lifecycle of development, from drug concept to commercialization.