Clinical Research Assistant

About Us

Rovia Clinical Research is dedicated to advancing healthcare by facilitating the development of innovative treatments for local patient communities. We foster a supportive and growth-oriented work environment where employees are valued and empowered. Join a collaborative team committed to making a significant impact, guided by our core principles of People First, Humility, Integrity, One Team, and Results Accountability.

Position Summary

The Clinical Research Assistant plays a crucial role in the successful execution of clinical trials. This position involves coordinating and implementing trial activities in strict adherence to study protocols, International Council for Harmonisation Good Clinical Practice (ICH/GCP) guidelines, sponsor directives, and Rovia Standard Operating Procedures (SOPs). The Assistant will work closely with site personnel to facilitate study initiation, patient recruitment, data accuracy, and overall trial achievement.

Key Responsibilities

• Coordinate and conduct patient visits according to established study protocols.
• Execute clinical procedures including taking vital signs, performing ECGs, processing specimens, and conducting phlebotomy as needed.
• Ensure that informed consent processes are completed accurately and documented appropriately.
• Provide guidance and education to participants throughout their study involvement, ensuring a positive experience.
• Monitor participant well-being, report any adverse events, and promptly escalate any emerging concerns.
• Maintain meticulous and timely source documentation and enter data into Electronic Data Capture (EDC) systems.
• Address and resolve data discrepancies to uphold data integrity.
• Manage investigational product inventory, including proper storage and handling.
• Prepare for and support site monitoring visits, audits, and regulatory inspections.
• Collaborate effectively with site staff and investigators to ensure adherence to protocols and optimize patient visit efficiency.
• Undertake additional responsibilities as assigned.

Skills and Abilities

• Possess a strong command of medical terminology and clinical procedures.
• Demonstrate a solid understanding of ICH/GCP standards and regulatory requirements.
• Exhibit exceptional organizational skills with a keen eye for detail.
• Communicate effectively with patients and colleagues, demonstrating strong interpersonal skills.
• Effectively manage multiple tasks and competing priorities in a dynamic setting.
• Proficient in using Microsoft Office Suite, EDC systems, and Clinical Trial Management Systems (CTMS).
• Capable of working autonomously and as part of a team.
• Maintain a high degree of professionalism and commitment to patient privacy.

Education and Experience

• A high school diploma is mandatory; a bachelor's degree in a relevant field is advantageous.
• Possess 0 to 1 year of experience in clinical research.
• Prior experience with patient-facing tasks such as phlebotomy, vital signs measurement, and ECGs is essential.
• A certification in Phlebotomy or as a Medical Assistant is preferred.

Additional Information

The specified pay range for this position is $20 to $24 USD per hour. This role is located in Jacksonville, FL, specifically at the University location.