Job Description

Job Purpose:

The job holder is responsible to coordinate and conduct clinical research trials, ensuring the safety and well-being of study participants while maintaining the integrity of study data. This role involves direct patient care, data collection, and collaboration with multidisciplinary teams in clinical facilities and clinical trial units.

Core Responsibilities

Clinical Trial Coordination:

• Assist in the execution of clinical trial protocols, including the identification of eligibility criteria and setting up study procedures.

• Recruit and screen potential study participants, obtain informed consent, and assess eligibility based on study criteria.

• Provide comprehensive nursing care to study participants, including monitoring vital signs, administering medications, and managing study-related interventions.

• Collect, record, and maintain accurate patient data according to study protocols and regulatory requirements, ensuring data integrity and confidentiality.

• Coordinate the collection, processing, and shipment of biological samples as required by the study protocol.

Compliance and Regulatory:

• Ensure adherence to clinical trial protocols and regulatory requirements, including Good Clinical Practice (GCP) guidelines.

• Maintain thorough and accurate documentation of all study-related activities, including patient interactions, data collection, and adverse event reporting.

• Prepare for and support internal and external audits by maintaining organized and compliant study records.

Communication and Collaboration:

• Serve as the primary contact for study participants, answering questions and addressing concerns throughout the trial period.

• Collaborate with principal investigators, research staff, and clinicians to ensure the successful execution and completion of clinical trials.

Patient Education and Support:

• Educate study participants and their families about the clinical trial process, study procedures, and potential risks and benefits.

• Provide emotional and psychological support to participants, ensuring a patient-centered approach and addressing any concerns.

Quality Assurance:

• Monitor adherence to study protocols, ensuring compliance with regulatory standards and institutional policies.

• Identify areas for process improvement to enhance study quality and efficiency.

Training and Mentorship:

• Train and mentor research staff in clinical trial procedures and best practices.

• Participate in educational sessions and seminars to stay current with developments in clinical research and nursing practices.

Educational Requirements:

• Master’s degree in nursing (MSN) or related advanced program.

• Bachelor’s degree in nursing (BSN).

• Licensed to practice nursing and able to perform basic procedures including collecting, handling and processing samples

Overall Experience:

• Minimum of 2 years of clinical nursing experience and clinical research or clinical trial nursing, preferably within research institution or hospital setting.

• Direct clinical care experience, including patient assessment, medication administration, and monitoring.

• Experience with clinical research protocols, patient recruitment, data collection, and regulatory compliance.

• Knowledge of GCP guidelines and experience with IRB submissions and clinical trial auditing.