Research Coordinator

About The Role

Responsibilitie

• sCoordinates administrative, operational, and regulatory support activities for research studies to facilitate compliant and efficient study start-up and ongoing research operations
• .Coordinates preparation, submission, tracking, and maintenance of regulatory and ethics documentation, including initial submissions, amendments, continuing reviews, safety reporting documentation, protocol deviations, and study closure activities
• .Maintains accurate, complete, and audit-ready investigator site files (ISF), regulatory binders, and essential study documentation in accordance with institutional policies, applicable regulations, and ICH-GCP requirements
• .Supports sponsor, CRO, IRB/REC, institutional, and regulatory authority monitoring visits, audits, and inspections through coordination and provision of required regulatory documentation
• .Tracks regulatory approvals, protocol deviations, safety reporting timelines, training compliance, delegation documentation, and essential document expirations to support ongoing regulatory compliance
• .Coordinates and maintains study-related regulatory records, trackers, research files, and documentation systems
• .Supports study start-up activities including collection, preparation, coordination, and submission of regulatory documentation, research applications, and study activation requirements
• .Coordinates study-related meetings, administrative logistics, research scheduling activities, and operational follow-up actions as assigned
• .Tracks study milestones, enrolment updates, regulatory deadlines, approvals, and reporting requirements to support research program oversight and operational efficiency
• .Assists with preparation, collection, review, and maintenance of research documentation including delegation logs, training records, study trackers, regulatory correspondence, and investigator site files
• .Maintains research tracking tools, regulatory trackers, and administrative records related to study status, submissions, approvals, and operational activities
• .Assists with maintenance of regulatory documentation and study records within applicable institutional, sponsor, and regulatory systems
• .Facilitates communication and coordination between investigators, Research Nurse Coordinators, research staff, sponsors, CROs, research administration offices, and institutional stakeholders regarding regulatory and operational research activities
• .Develops and maintains working knowledge of assigned research protocols, institutional research policies, regulatory requirements, and research operations workflows
• .Assists with development and maintenance of training tools, educational materials, and operational resources related to research administration and regulatory processes
• .Maintains professional relationships through effective communication and collaboration with internal and external stakeholders
• .Ensures confidentiality, integrity, and secure handling of research-related information and documentation in accordance with institutional and regulatory requirements
• .Performs other duties as assigned within the scope of the role
• .

Qualificatio

• nsEducation: Bachelor’s Degree or equivalent Degree in Life Sciences, Public Health or related fiel
• d.

Required Ski

• llsMinimum of 3 years of administrative, operational or healthcare related experien
• ce.Experience supporting research, healthcare operations or project coordination activiti
• es.Clinical research coordination experien
• ce.Experience supporting regulatory submissions and clinical trial compliance activiti
• es.

Preferred Sk

• illsKnowledge of ICH-GCP, human subject protection principles and applicable research regulatory requireme
• nts.Proficient in Microsoft Office applications including Excel, Word and PowerPo
• int.Strong organizational and coordination ski
• lls.Ability to manage multiple priorities and timeli
• nes.Strong written and verbal communication ski
• lls.Demonstrated ability to maintain accurate records and documentat
• ion.Strong attention to detail and documentation management ski
• lls.Ability to work collaboratively across multidisciplinary te
• ams.Knowledge of research regulatory processes and research administration workflows prefer
• red.Experience with research databases, CTMS or electronic research systems prefer
• red.