Clinical Research Coordinator-Burns

Role Overview

Clinical Research Coordinator – Burns at Sheikh Shakhbout Medical City (SSMC).

Role Purpose

The Clinical Research Coordinator reports to the principal investigator, supervisor, or other research protocol staff and coordinates complex clinical research studies, managing protocol implementation, participant enrollment, data quality, and regulatory compliance while collaborating across departments and external research centers.

Key Responsibilities

Protocol Development & Maintenance

• Coordinate complex interventional and therapeutic clinical research protocols with minimal supervisor direction in compliance with regulatory laws and institutional guidelines.
• Manage the protocol document and process through editing, amendments, and proofing.
• Coordinate study logistics including blood collection kits, data collection booklets, and Clinical Trials Unit access.
• Verify protocol content to meet institutional and federal standards.
• Communicate with study sites and federal agencies regarding study status changes.
• Prepare and submit Federal and Institutional Review Board/Research Ethics Board (IRB/REC) documents.
• Provide consultative expertise regarding regulatory and policy requirements.
• Apply investigators' scientific data accurately into a cohesive format for the protocol document and associated procedures consistent with internal and external policies and regulatory requirements.
• Participate in other protocol development activities and execute additional assignments as warranted and assigned.

Research Operations & Coordination

• Collaborate with the research team to assess the feasibility and management of research protocols.
• Ensure implementation of research protocols after IRB/REC approval.
• Provide information as appropriate for progress reports.
• Screen, enroll, and recruit research participants.
• Coordinate schedules and monitor research activities and subject participation.
• Create and implement recruitment strategies for research studies.

Data & Compliance Management

• Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately.
• Manage, monitor, and report research data to maintain quality and compliance.
• Perform administrative and regulatory duties related to the study as appropriate.

Stakeholder Management & Support

• Provide education and training for others within the department.
• Work cooperatively with other research staff, giving direction as needed.
• Collaborate with various departments within the institution.
• Work cooperatively with other investigators and personnel at all levels.
• Interact with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.

Patient Safety & Study Oversight

• Ensure that patient safety is protected and monitor participant progress through the study.
• Monitor investigator activities to ensure that research projects remain on schedule and within budget.

Qualifications & Experience

Required

• Minimum of 1 year of experience in a clinical research setting or related field.
• Bachelor's level training in one of the science disciplines.

Desired

• Master's, nursing degree, or PhD.
• Graduate or diploma from a study coordinator training program.

Skills & Competencies

• Protocol development and regulatory compliance.
• Data management and quality assurance.
• Participant recruitment and enrollment.
• Adverse event and protocol deviation identification and reporting.
• Administrative and regulatory documentation.
• Interpersonal communication and stakeholder collaboration.
• Project management and scheduling.