Clinical Research Associate

Role Description

Qity Clinical, a specialized service provider offering expert Clinical Affairs consulting to life science companies, is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our team. This role goes beyond a standard monitoring role, offering a wide variety of tasks and involvement in project management, making it an excellent opportunity for professional growth. As a CRA at Qity Clinical, you will play a key role in supporting our clients' clinical development strategies. The candidate will work primarily from the Qity Clinical office, but may also be allocated to client sites and travel to study sites as needed.

Responsibilities

• Conduct on-site and remote monitoring visits to ensure compliance with study protocols, GCP/ICH guidelines, and relevant regulations.
• Verify the accuracy and completeness of source documents and case report forms (CRFs).
• Monitor patient safety and report any adverse events or protocol deviations.
• Ensure proper handling and storage of investigational products.
• Train and support study site staff on protocol requirements and data collection procedures.
• Prepare and submit monitoring visit reports and follow-up letters.
• Assist in the resolution of data queries and discrepancies.
• Maintain accurate and up-to-date study documentation.
• Collaborate with study site personnel, project managers, and other team members.
• Contribute to the preparation of study-related documents and reports.
• Assist in the preparation and conduct of investigator meetings.
• Support the Trial Master File (TMF) maintenance and audit readiness.
• Participate in varied clinical project management activities.
• Assist in the building and maintenance of electronic clinical trial management systems.
• Contribute to the development and writing of standard operating procedures (SOPs).

Qualifications

• Master’s degree in a scientific field is preferred.
• Experience in clinical research, either through employment or education.
• Familiarity with good clinical practice guidelines (ISO 14155 or ICH-GCP) or a strong willingness to learn.
• Understanding of clinical trial procedures and regulations.
• Strong computer skills (including proficiency in Microsoft Office Suite).
• Strong organizational and time management skills.
• Attention to detail and accuracy.  
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.  
• Willingness to travel to study sites as required.
• Quick learner with a proactive attitude.

Why Join Qity Clinical?

Qity Clinical offers a unique opportunity to contribute to impactful clinical affairs consulting. As a starting company, we provide a dynamic and collaborative work environment where you can:

• Play a key role in the development of our clinical affairs services.
• Gain experience with a variety of clinical studies and therapeutic areas.
• Learn and apply best practices in clinical trial monitoring.
• Benefit from significant career growth opportunities due to the varied nature of the role.
• Contribute to the success of important clinical research.
• Work in a supportive team environment.
• Gain broad experience in clinical affairs, including project management, systems building, and SOP development.
• We offer a flexible Work From Home (WFH) policy.
• We prioritize creating an environment that fosters flexibility, growth, and personal development.