Work180
Clinical Operations Specialist
Work180, Carlsbad, California, United States, 92002
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job Overview
The Clinical Operations Specialist will provide support and a level of oversight to the Clinical Research Operations Department. This position will liaise between the Teams of Clinical Operations, research sites, and clients to manage and facilitate clinical projects.This position will either be located remotely or at our Carlsbad, CA office.Responsibilities:Participates in study start-up activity including, but not limited to contracts and IRB submissions.Responsible for tracking start-up status at research sites.Collaborates with the Project Manager on the development and preparation of study-specific materials, forms, and processes.Review and understand research protocols and eligibility criteria.Serves as the primary contact during contract negotiation phase with clinical sites.Liaise between company, site and sponsor legal teams.Supports sites in obtaining IRB Approval, site-specific ICFS, and developing submission materials.Collaborates with IRB to resolve any site or study level issues.Attend Sponsor calls and take meeting minutes.Perform TMF set-up, maintenance, and on-going quality review of essential documents.Follow up with study leads to ensure quality findings are addressed and closed.Perform QC and maintenance of eTMF for assigned study leads.Participation in audit, inspection readiness preparation and inspection activities as needed.Assist department study leads with uploading, archiving and managing documents within the eTMF and help study team members resolve issues.Resolve noncompliance with overdue quality review findings and overdue in-progress eTMF documents, to improve TMF accuracy.Support the coordination of the transfer of study-specific trial master files from the CRO.Perform additional clinical research, general project or administrative tasks.What your background should look like:
Bachelor’s degree, in a medical-related or science field preferred.1-2 years of experience in clinical research.Must have basic knowledge of sponsor site clinical trials and/or CRO industry experience.Experience with trial master file management.Meticulous attention to detail and accuracy.Knowledge of Clinical Study Agreements preferred.Effective time management, organizational skills, and ability to manage multiple tasks.Excellent verbal and written communication skills required.Outlook and MS Office skills.Ability to handle difficult situations professionally and maintain a professional and caring demeanor.Proven ability to collaborate in a team environment and work independently.Punctual, reliable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.Must be highly motivated.Previous experience participating in TMF audits preferred.Ability to problem-solve unstructured or ambiguous challenges.
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The Clinical Operations Specialist will provide support and a level of oversight to the Clinical Research Operations Department. This position will liaise between the Teams of Clinical Operations, research sites, and clients to manage and facilitate clinical projects.This position will either be located remotely or at our Carlsbad, CA office.Responsibilities:Participates in study start-up activity including, but not limited to contracts and IRB submissions.Responsible for tracking start-up status at research sites.Collaborates with the Project Manager on the development and preparation of study-specific materials, forms, and processes.Review and understand research protocols and eligibility criteria.Serves as the primary contact during contract negotiation phase with clinical sites.Liaise between company, site and sponsor legal teams.Supports sites in obtaining IRB Approval, site-specific ICFS, and developing submission materials.Collaborates with IRB to resolve any site or study level issues.Attend Sponsor calls and take meeting minutes.Perform TMF set-up, maintenance, and on-going quality review of essential documents.Follow up with study leads to ensure quality findings are addressed and closed.Perform QC and maintenance of eTMF for assigned study leads.Participation in audit, inspection readiness preparation and inspection activities as needed.Assist department study leads with uploading, archiving and managing documents within the eTMF and help study team members resolve issues.Resolve noncompliance with overdue quality review findings and overdue in-progress eTMF documents, to improve TMF accuracy.Support the coordination of the transfer of study-specific trial master files from the CRO.Perform additional clinical research, general project or administrative tasks.What your background should look like:
Bachelor’s degree, in a medical-related or science field preferred.1-2 years of experience in clinical research.Must have basic knowledge of sponsor site clinical trials and/or CRO industry experience.Experience with trial master file management.Meticulous attention to detail and accuracy.Knowledge of Clinical Study Agreements preferred.Effective time management, organizational skills, and ability to manage multiple tasks.Excellent verbal and written communication skills required.Outlook and MS Office skills.Ability to handle difficult situations professionally and maintain a professional and caring demeanor.Proven ability to collaborate in a team environment and work independently.Punctual, reliable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.Must be highly motivated.Previous experience participating in TMF audits preferred.Ability to problem-solve unstructured or ambiguous challenges.
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