Clinical Research Coordinator

About Us

Rovia Clinical Research is dedicated to advancing patient health by introducing innovative treatments within local communities. We foster a supportive and valued work environment where employees are encouraged to grow their careers. Join a team committed to collaboration and making a significant impact, guided by our core values: People First, Humility, Integrity, One Team, and Results Accountability.

Position Summary

The Clinical Research Coordinator (CRC) plays a crucial role in managing and executing clinical trials. This involves ensuring adherence to study protocols, ICH/GCP guidelines, sponsor expectations, and Rovia's Standard Operating Procedures (SOPs). The CRC works closely with site teams to facilitate study startup, patient enrollment, maintain data quality, and contribute to the overall success of the trials.

Key Responsibilities

• Coordinate and conduct patient visits according to study protocols.
• Perform essential clinical tasks, including taking vital signs, performing EKGs, collecting and processing specimens, and phlebotomy as required.
• Ensure that informed consent is obtained correctly and thoroughly documented.
• Guide and educate participants throughout the study, prioritizing a positive patient experience.
• Monitor participant safety, report any adverse events, and escalate critical concerns promptly.
• Maintain accurate and timely source documentation and enter data into Electronic Data Capture (EDC) systems.
• Address and resolve data queries to ensure the integrity of the study data.
• Manage investigational product accountability, including proper storage and handling.
• Prepare for and support monitoring visits, audits, and regulatory inspections.
• Collaborate effectively with site staff and investigators to ensure protocol compliance and efficient patient flow.
• Undertake additional duties as assigned to support study operations.

Skills and Abilities

• Possess a strong understanding of medical terminology and clinical procedures.
• Demonstrate knowledge of ICH/GCP guidelines and regulatory requirements.
• Exhibit excellent organizational skills with meticulous attention to detail.
• Communicate effectively with patients and colleagues, demonstrating strong interpersonal skills.
• Manage multiple tasks and competing priorities efficiently in a dynamic environment.
• Proficient in using Microsoft Office Suite, EDC systems, and Clinical Trial Management Systems (CTMS).
• Ability to work autonomously and as part of a team.
• Maintain a high level of professionalism and uphold patient confidentiality.

Education and Experience

• A high school diploma is required; a bachelor's degree in a relevant field is preferred.
• A minimum of 1 year of experience in clinical research is necessary.
• Prior experience with patient-facing activities such as phlebotomy, vital signs monitoring, and EKGs is highly desirable.