Clinical Research Coordinator/ Team Leader

We are looking for Team Leader of the Clinical Research Unit is responsible for overseeing a team of 6 Study Coordinators and ensuring the efficient and compliant conduct of clinical research studies. This role involves comprehensive management of study operations, including staff training, patient recruitment strategies, study progress monitoring, and effective communication within the research team.

Key Responsibilities:

Supervision and Leadership:

• Provide leadership and direction to a team of 6 Study Coordinators.
• Mentor and support Study Coordinators in their professional development and performance.

Training and Development:

• Conduct initial and ongoing training for new and existing staff on study protocols, regulatory requirements, and standard operating procedures (SOPs).
• Ensure staff compliance with GCP (Good Clinical Practice) guidelines and regulatory standards.

Study Coordination and Management:

• Oversee the coordination and management of multiple clinical research studies concurrently.
• Develop patient recruitment strategies in collaboration with the research team and principal investigators.
• Monitor and ensure adherence to study timelines and milestones.

Communication and Collaboration:

• Serve as the primary point of contact for communication within the research team regarding study progress, participant enrollment, and protocol deviations.
• Facilitate effective communication with principal investigators, sponsors, regulatory authorities, and Institutional Review Boards (IRBs).

Quality Assurance and Compliance:

• Ensure compliance with study protocols, SOPs, GCP, and applicable regulatory requirements.
• Address and resolve any issues related to study conduct promptly and appropriately.

Data Management and Documentation:

• Oversee data collection, entry, and management activities to ensure accuracy and completeness.
• Maintain comprehensive study documentation and records in accordance with regulatory standards.

Qualifications and Experience:

• Bachelor’s degree in a relevant scientific field.
• Minimum of 3 years of experience as a Study Coordinator in clinical research; experience in a leadership or supervisory role preferred.
• In-depth knowledge of clinical research regulations MOH and GCP guidelines.
• Strong organizational, managerial, and interpersonal skills.
• Excellent written and verbal communication skills.

Attributes:

• Leadership: Ability to motivate and lead a team of Study Coordinators effectively.
• Problem-Solving: Strong analytical and problem-solving skills to address study-related issues.
• Detail-Oriented: Attention to detail in overseeing study protocols, data management, and regulatory compliance.
• Team Player: Collaborative approach to working with cross-functional teams and stakeholders.
• Adaptability: Ability to manage multiple priorities in a dynamic and fast-paced environment.