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Research Coordinator

Cleveland Clinic Abu Dhabi
Abu Dhabi Emirate, UAE
Full Time
Mid
3 weeks ago
Regulatory SubmissionsICH GCPClinical Research CoordinationMicrosoft OfficeOrganizational SkillsCommunication
Free

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Regulatory SubmissionsICH GCPClinical Research Coordination
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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.
  • This is a non clinical position and does not involve direct patient care, clinical procedures, informed consent, or participant facing research activities.

Responsibilities

  • Coordinates administrative, operational, and regulatory support activities for research studies.
  • Coordinates preparation, submission, tracking, and maintenance of regulatory and ethics documentation.
  • Maintains accurate, complete, and audit ready investigator site files (ISF), regulatory binders, and essential study documentation.
  • Supports sponsor, CRO, IRB/REC, institutional, and regulatory authority monitoring visits, audits, and inspections.
  • Tracks regulatory approvals, protocol deviations, safety reporting timelines, training compliance, delegation documentation, and essential document expirations.
  • 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.
  • Coordinates study related meetings, administrative logistics, research scheduling activities, and operational follow up actions.
  • Tracks study milestones, enrolment updates, regulatory deadlines, approvals, and reporting requirements.
  • Assists with preparation, collection, review, and maintenance of research documentation including delegation logs, training records, study trackers, and investigator site files.
  • Maintains research tracking tools, regulatory trackers, and administrative records related to study status, submissions, approvals, and operational activities.
  • Facilitates communication and coordination between investigators, Research Nurse Coordinators, research staff, sponsors, CROs, research administration offices, and institutional stakeholders.

Qualifications

  • Bachelor's Degree or equivalent Degree in Life Sciences, Public Health or related field.
  • Minimum of 3 years of administrative, operational or healthcare related experience.
  • Clinical research coordination experience.
  • Experience supporting regulatory submissions and clinical trial compliance activities.
  • Knowledge of ICH GCP, human subject protection principles and applicable research regulatory requirements preferred.
  • Proficient in Microsoft Office applications including Excel, Word and PowerPoint.
  • Strong organizational and coordination skills.
  • Ability to manage multiple priorities and timelines.
  • Strong written and verbal communication skills.
  • Demonstrated ability to maintain accurate records and documentation.
  • Strong attention to detail and documentation management skills.
  • Ability to work collaboratively across multidisciplinary teams.

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