Clinical Research Assistant

About Rovia Clinical Research

Rovia Clinical Research is dedicated to advancing innovative medical treatments that enhance the well-being of patient communities locally. The organization prioritizes creating a supportive and inclusive work environment where employees feel valued and motivated to develop their careers. Emphasizing core principles such as People First, Humility, Integrity, One Team, and Results Accountability, the company fosters meaningful teamwork and impactful outcomes.

Position Overview

The Clinical Research Assistant position entails managing and executing clinical studies in strict compliance with study guidelines, ICH/GCP standards, sponsor mandates, and internal SOPs. This role involves close collaboration with site teams to facilitate study initiation, participant recruitment, data accuracy, and overall project success.

Key Duties

• Coordinate and conduct patient visits aligned with clinical trial protocols.
• Carry out clinical procedures including vital signs collection, ECG administration, specimen handling, and phlebotomy when applicable.
• Obtain and document informed consent from study participants properly.
• Provide education and support to participants throughout their involvement to ensure positive experiences.
• Monitor patient safety, report adverse events promptly, and escalate issues as necessary.
• Maintain timely and precise source documentation and electronic data capture.
• Address data queries and uphold data integrity standards.
• Manage investigational product accountability, ensuring appropriate storage and handling.
• Assist and prepare for monitoring visits, audits, and regulatory inspections.
• Work collaboratively with site staff and investigators to assure adherence to protocols and efficient visit flow.
• Perform additional tasks as assigned.

Skills and Competencies

• In-depth knowledge of medical terminology and clinical research procedures.
• Familiarity with ICH/GCP guidelines and regulatory compliance.
• Exceptional organizational abilities and keen attention to detail.
• Strong interpersonal skills with an emphasis on patient communication.
• Capacity to balance multiple responsibilities in a dynamic work environment.
• Competence with Microsoft Office suite, electronic data capture systems, and clinical trial management software.
• Able to work effectively both independently and as part of a team.
• Maintains professionalism with a strong commitment to patient confidentiality.

Education and Experience

• High school diploma is required; bachelor's degree in a related discipline is preferred.
• Between zero and one year of experience in clinical research.
• Prior experience in patient-facing clinical activities such as phlebotomy, vital sign measurement, ECGs, or laboratory processing is mandatory.
• Certifications like Phlebotomy or Medical Assistant are advantageous.
• Having current IATA certification is preferred.

Additional Information

This role requires availability to begin work at 6:00 AM.