Clinical Research Coordinator

Job Summary

Key Responsibilities

• Coordinate and oversee day-to-day activities related to assigned clinical studies.
• Review study protocols and ensure all trial activities are conducted in compliance with protocol requirements.
• Recruit, screen, and enroll eligible study participants according to inclusion and exclusion criteria.
• Obtain and document informed consent from study participants prior to study procedures.
• Schedule participant visits and coordinate study assessments, procedures, and follow-ups.
• Collect, document, and maintain accurate study data in Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
• Maintain essential regulatory documents, investigator site files, and study records.
• Monitor participant safety by identifying, documenting, and reporting adverse events and serious adverse events in accordance with regulatory timelines.
• Coincide with Principal Investigators, sponsors, Contract Research Organizations (CROs), laboratory personnel, and other study stakeholders.
• Prepare for and support sponsor monitoring visits, audits, and regulatory inspections.
• Ensure adherence to Good Clinical Practice (GCP), institutional policies, and applicable local and international regulations.
• Track study timelines, recruitment targets, and protocol milestones.
• Aid with study initiation, amendments, close-out activities, and archiving of study documents.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or a related healthcare field.
• Prior experience in clinical research or clinical trial coordination is preferred.
• Certification in Good Clinical Practice (GCP) is an advantage.

Required Skills

• Strong understanding of clinical trial processes and research ethics.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• Excellent organizational and time-management skills.
• Strong verbal and written communication abilities.
• Attention to detail and accuracy in documentation.
• Proficiency in Microsoft Office applications and EDC systems.
• Ability to work independently and collaboratively within multidisciplinary teams.
• Educated problem-solving and interpersonal skills.

Working Conditions

• Work is typically performed in hospitals, research institutions, academic medical centers, or clinical research organizations.
• May require flexibility to accommodate participant schedules and sponsor visits.