Clinical Trial Coordinator
Purpose of Job:
The Clinical Trial Coordinator (CTC) participates in the planning and coordination activities around the clinical trial aspects of a clinical project. He or she has the responsibility to support the project team to achieve quality results in a cost-effective timely manner. In doing this, the CTC represents inVentiv Health Clinical to the sponsor and the CRO, site personnel, and colleagues with professionalism and integrity.
Job Components:
Support the study team in the successful execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs).
This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the postholder.
Wishlist at COMPANY site, activities will include but are not limited to:
o Coordinating CDA preparation, collection and execution; legal review form completion
o Distributing, collecting and reviewing Financial Disclosures
o Setting-up, updating and maintaining the clinical trial management system e.g. IMPACT
o Creating, reviewing, approving, distributing and tracking Site Reference Materials e.g. Study Manual, Pharmacy Manual, Regulatory / Investigator Binder
o Preparing and maintaining Insurance certificates
o Create and distribute recruitment materials
o Manages, reviews drug shipment, destruction, and return; Product Recall Process; expiry & batch number tracking to be sent to sites (non-IXRS studies)
o Coordinates internal lab samples supply set up and shipment; assist with sample queries
o Participate in study design and execution by contributing operational experience and expertise; Provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications
o Tracking protocol deviations
o Populating, distributing, reviewing and tracking all essential documents throughout the study
o Managing temperature excursions
o SUSAR coordination
o Creating and maintaining VCTR, COMPANY's CT.gov registry platform
o Supporting audit/inspection readiness; Keep R&D Compliance updated with changes to site list and timelines for audit planning
o Tracking of study visits (for budget purposes) with CRO & EDC
o Ensuring CCF completion and quality
o Coordinating the final transfer of the CCF from the CRO(s)
o Delegating administrative tasks to the CTA as applicable
o Ad hoc tasks as assigned by the inVentiv Health Clinical Site Manager
Minimum Requirements:
Qualifications:
o Bachelor's level degree in life sciences, pharmacy or nursing preferred
o 1-2 years' experience within the Pharmaceutical/CRO industry or equivalent site experience.
o Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
o Experience working in a team across multiple functional areas (e.g., work with Quality Assurance, Data Management, Medical Affairs, Finance)
o Excellent communication, relationship building and interpersonal skills
o Excellent organizational skills and ability to prioritize and multi task
o Proficient in Microsoft Office (e.g., Word, Excel, and Outlook)Estimated Salary: $20 to $28 per hour based on qualifications.
The Clinical Trial Coordinator (CTC) participates in the planning and coordination activities around the clinical trial aspects of a clinical project. He or she has the responsibility to support the project team to achieve quality results in a cost-effective timely manner. In doing this, the CTC represents inVentiv Health Clinical to the sponsor and the CRO, site personnel, and colleagues with professionalism and integrity.
Job Components:
Support the study team in the successful execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs).
This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the postholder.
Wishlist at COMPANY site, activities will include but are not limited to:
o Coordinating CDA preparation, collection and execution; legal review form completion
o Distributing, collecting and reviewing Financial Disclosures
o Setting-up, updating and maintaining the clinical trial management system e.g. IMPACT
o Creating, reviewing, approving, distributing and tracking Site Reference Materials e.g. Study Manual, Pharmacy Manual, Regulatory / Investigator Binder
o Preparing and maintaining Insurance certificates
o Create and distribute recruitment materials
o Manages, reviews drug shipment, destruction, and return; Product Recall Process; expiry & batch number tracking to be sent to sites (non-IXRS studies)
o Coordinates internal lab samples supply set up and shipment; assist with sample queries
o Participate in study design and execution by contributing operational experience and expertise; Provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications
o Tracking protocol deviations
o Populating, distributing, reviewing and tracking all essential documents throughout the study
o Managing temperature excursions
o SUSAR coordination
o Creating and maintaining VCTR, COMPANY's CT.gov registry platform
o Supporting audit/inspection readiness; Keep R&D Compliance updated with changes to site list and timelines for audit planning
o Tracking of study visits (for budget purposes) with CRO & EDC
o Ensuring CCF completion and quality
o Coordinating the final transfer of the CCF from the CRO(s)
o Delegating administrative tasks to the CTA as applicable
o Ad hoc tasks as assigned by the inVentiv Health Clinical Site Manager
Minimum Requirements:
Qualifications:
o Bachelor's level degree in life sciences, pharmacy or nursing preferred
o 1-2 years' experience within the Pharmaceutical/CRO industry or equivalent site experience.
o Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
o Experience working in a team across multiple functional areas (e.g., work with Quality Assurance, Data Management, Medical Affairs, Finance)
o Excellent communication, relationship building and interpersonal skills
o Excellent organizational skills and ability to prioritize and multi task
o Proficient in Microsoft Office (e.g., Word, Excel, and Outlook)Estimated Salary: $20 to $28 per hour based on qualifications.
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