Job Description

THE CLINICAL TRIAL COORDINATOR I ROLE

The Clinical Trial Coordinator (CTC) I assists the clinical research team, supporting Project Managers (PMs), Study Start-up team, Clinical Research Associates (CRAs), and clinical sites to ensure studies are conducted in accordance with ICH GCP, applicable laws, SOPs, and the protocol in respect of study budget and timelines.

Essential Job Functions

• Responsible (in collaboration with PM, CRAs, and Study Start-up team, as applicable) for site identification and feasibility, including initial site outreach, follow-up, and circulation and collection of feasibility questionnaires and Non-disclosure Agreements (NDAs)
• Supports PM with the management of and participation in internal, client/sponsor, scientific, and other meetings as required, including but not limited to supporting with scheduling meetings and preparing agendas and meeting minutes
• Responsible (under PM oversight and in collaboration with Study Start-up team, as applicable) for site start-up activities, including Ethics Committees and Institutional Review Boards and Regulatory submissions (at site, national, and international level, as applicable) and site contract and budget negotiation
• Maintains relationships with Ethics Committees (ECs) and Competent Authorities (CAs), as applicable
• Responsible for document management including Trial Master File (TMF) setup maintenance and TMF QC (under PM oversight)
• Supports PM with Investigator Site File (ISF) preparation and distribution to sites
• Supports the PM with the management of study site supplies
• Supports collection and review of site Essential Documents, in collaboration with CRAs
• May support regular communication with sites to address questions, ensure protocol/GCP compliance, determine study progress and monitor subject accrual
• Supports PM with study management activities throughout life cycle of study; collaborates in the preparation of weekly/monthly and/or ad hoc project reports, updating CTMS, and maintaining study-specific trackers as needed
• Supports PM with maintenance of study team training materials
• Supports PM with site/vendor invoicing management, as applicable
• Supports CRAs with follow-up activities
• Supports PM with document translation, as applicable
• Participates in audits, as applicable
• Performs additional duties as assigned
• 
  

Preparation, Knowledge, Skills & Abilities

• Graduation in scientific/health field or equivalent experience
• Strong command of English, both written and verbal
• Proficient with MS Office Suite
• Quality focused; ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges
• Strong communication and interpersonal skills with customer service orientation
• Professional and trustworthy
• Permanent authorization to work in applicable country(-ies)
• Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements.

Job Description

THE CLINICAL TRIAL COORDINATOR I ROLE

The Clinical Trial Coordinator (CTC) I assists the clinical research team, supporting Project Managers (PMs), Study Start-up team, Clinical Research Associates (CRAs), and clinical sites to ensure studies are conducted in accordance with ICH GCP, applicable laws, SOPs, and the protocol in respect of study budget and timelines.

Essential Job Functions

• Responsible (in collaboration with PM, CRAs, and Study Start-up team, as applicable) for site identification and feasibility, including initial site outreach, follow-up, and circulation and collection of feasibility questionnaires and Non-disclosure Agreements (NDAs)
• Supports PM with the management of and participation in internal, client/sponsor, scientific, and other meetings as required, including but not limited to supporting with scheduling meetings and preparing agendas and meeting minutes
• Responsible (under PM oversight and in collaboration with Study Start-up team, as applicable) for site start-up activities, including Ethics Committees and Institutional Review Boards and Regulatory submissions (at site, national, and international level, as applicable) and site contract and budget negotiation
• Maintains relationships with Ethics Committees (ECs) and Competent Authorities (CAs), as applicable
• Responsible for document management including Trial Master File (TMF) setup maintenance and TMF QC (under PM oversight)
• Supports PM with Investigator Site File (ISF) preparation and distribution to sites
• Supports the PM with the management of study site supplies
• Supports collection and review of site Essential Documents, in collaboration with CRAs
• May support regular communication with sites to address questions, ensure protocol/GCP compliance, determine study progress and monitor subject accrual
• Supports PM with study management activities throughout life cycle of study; collaborates in the preparation of weekly/monthly and/or ad hoc project reports, updating CTMS, and maintaining study-specific trackers as needed
• Supports PM with maintenance of study team training materials
• Supports PM with site/vendor invoicing management, as applicable
• Supports CRAs with follow-up activities
• Supports PM with document translation, as applicable
• Participates in audits, as applicable
• Performs additional duties as assigned
• 
  

Preparation, Knowledge, Skills & Abilities

• Graduation in scientific/health field or equivalent experience
• Strong command of English, both written and verbal
• Proficient with MS Office Suite
• Quality focused; ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges
• Strong communication and interpersonal skills with customer service orientation
• Professional and trustworthy
• Permanent authorization to work in applicable country(-ies)
• Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements.