Research Coordinator Full Time NEW

About the Role

This position is responsible for coordinating the operational, administrative and regulatory activities associated with human subjects research studies and research programs. The role supports investigators and research teams with study start up, regulatory submissions, essential document management, research tracking, scheduling, and general study administration to ensure compliant and efficient research operations. This position works collaboratively with investigators, research nurse coordinators, sponsors, CROs, and institutional stakeholders to support study activation, regulatory compliance, audit readiness, and ongoing research administration. This is a non-clinical position and does not involve direct patient care, clinical procedures, informed consent, or participant-facing research activities. The role is intended to support operational efficiency within the research program by coordinating non-clinical research activities.

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

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Qualificatio

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

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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

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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

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