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Clinical Research Operations Specialist
2 months ago
Guidehouse is seeking a highly skilled Clinical Research Operations Specialist to join our team. As a key member of our Clinical Trials Unit, you will play a critical role in supporting the development and execution of clinical research protocols.
Key Responsibilities- Protocol Development and Review
Develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, ensuring accuracy, consistency, and completeness.
Regulatory ComplianceEnsure compliance with regulatory requirements, including IRB submissions, regulatory document management, and other regulatory study tasks.
Documentation and ReportingPrepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation.
Regulatory CorrespondenceDevelop and review completed IND and IDE safety, clinical study reports, and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
Regulatory Binder MaintenanceMaintain all regulatory trial documentation, including a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs, and safety reports.
Collaboration and CommunicationCollaborate with researchers, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities to ensure seamless execution of clinical research protocols.
Requirements- Education
Masters Degree in a relevant field, such as Miscellaneous Health Medical Professions, Nursing, Biology, or General Science.
ExperienceA minimum of TWO (2) years of experience in a clinical trial or clinical research setting, with expertise in regulatory compliance, protocol development, and navigation.
SkillsStrong writing skills, with experience writing clinical research protocols; proficiency in Clinical Trial Management System (CTMS), Electronic Medical Records System, and/or Electronic Data Capture System.
CertificationsCertification in Association of Clinical Research Professionals (ACRP) or Certified Clinical Research Professional (CCRP) preferred.
What We OfferGuidehouse offers a comprehensive total rewards package, including competitive compensation, flexible benefits, and opportunities for professional growth and development.
