Job Summary: 

• Provide general administrative support to the Project Management Department and assistance to the Project Managers and Project Directors
• Assist the Project Management Team in the completion of all required tasks to meet departmental and project objectives
• Support the Project Manager/Director, Project Management, in performing the administrative and logistical tasks of the projects
• Coordinate meeting arrangements and conduct other administrative and logistical functions
• Set up, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival
• Assist in the tracking of the project progress and activities
• Assist in the tracking and distribution of safety reports
• Responsible for the preparation, handling and tracking of Ethics and Regulatory submissions, annual, safety and end-of-trial reporting, and facilitating any correspondence
• Secure adherence to Good Clinical Practice, current regulatory requirements, and internal SOPs
• Frequent face-to-face, written and telephone contact with various persons involved in the studies

Skills on Resume: 

• Administrative Support (Hard Skills)
• Project Coordination (Hard Skills)
• Document Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Meeting Coordination (Hard Skills)
• Communication Skills (Soft Skills)
• Progress Tracking (Hard Skills)
• Safety Reporting (Hard Skills)

Job Summary: 

• Support Clinical Operations in administrative tasks related to the management of clinical trials.
• Support Clinical Trial Managers in vendor coordination and oversight (i.e. CROs, Central Labs)
• Work independently with vendors per CTM’s instructions and guidance.
• Support with the coordination and management of clinical trial supplies including tracking and shipment of materials.
• Assist CTMs in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Manage study-specific systems and clinical tracking systems (TMF, EDC, SharePoint, etc.).
• Be responsible for set-up, monitoring, periodical review, QC check, verifying and archiving the Trial Master File.
• Maintain and complete paper and electronic clinical trial documents,
• Internal Meeting logistics, preparation and coordination, meeting minutes preparation.

Skills on Resume: 

• Clinical Trial Management Systems (Hard Skills)
• Vendor Coordination and Oversight (Hard Skills)
• Clinical Documentation Management (Hard Skills)
• Clinical Trial Supplies Management (Hard Skills)
• Quality Control (Hard Skills)
• Administrative Support (Soft Skills)
• Independent Work with Guidance (Soft Skills)
• Attention to Detail and Compliance (Soft Skills)

Job Summary: 

• Support project teams in the full spectrum of clinical research activities such as study start-up, site management/closure, document management (eTMF and paper-based), regulatory and site start-up responsibilities, meeting planning
• Coordinate internal and external stakeholders, facilitating smooth processes and top-quality
• Administrative support of various contract teams including approvals, quality assurance and document management (contract databases and/or paper-based)
• Set up and maintain clinical investigator files and documentation
• Prepare investigator budget payments and tracking systems, generate tracking reports
• Enter and maintain data into selected study tracking databases and ensure a high level of data quality
• Prepare monitoring visit documentation for CRAs, Project Managers, etc.
• Oversee appropriate archiving of study documents and other materials
• Assist in the planning, logistics and preparation of Investigator meetings.
• Keep up to date with all changes/required knowledge on ICH GCP, SOPs and regulatory requirements.

Skills on Resume: 

• Clinical Research Operations (Hard Skills)
• Document Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Stakeholder Coordination (Soft Skills)
• Data Management (Hard Skills)
• Investigator Support (Hard Skills)
• Administrative Support (Hard Skills)
• Meeting Planning and Logistics (Soft Skills)

Job Summary: 

• Maintains and coordinates the administrative aspects of Integra's Clinical Affairs department including clinical studies according to GCPs and SOPs
• Provides support for the preparation of clinical study reports, annual reports, interim updates and other study or regulatory documents
• Works with study teams to prepare clinical study documents, including investigator meeting materials, site and training information
• Serves as a resource for clinical study sites and can triage questions/needs
• Implements and maintains clinical filing systems for all shared documents and files and proactively identifies operational process improvements
• Files and maintains study documents in the study Trial Master Files (TMFs)
• Performs ongoing and final study-level and site-level TMF reconciliation
• Performs data entry into designated clinical tracking systems following project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
• Assists with the processing of both vendor and site payments
• Assists with gathering and tracking clinical trial accruals

Skills on Resume: 

• Clinical Research Compliance (Hard Skills)
• Document Management (Hard Skills)
• Coordination and Support (Soft Skills)
• Clinical Study Site Support (Soft Skills)
• Process Improvement (Hard Skills)
• Trial Master File Management (Hard Skills)
• Data Management (Hard Skills)
• Financial Administration (Hard Skills)

Job Summary: 

• Provides accurate progress reports on assigned tasks and projects
• Contributes to wider organizational goals and/or activities as assigned
• Ensures study compliance by understanding and applying all relevant SOPs
• Arranging and minuting Study Team Meetings and completing actions
• Assist in the project management and monitoring of clinical studies, including liaison with study sites, monitors, drug vendors, central laboratories and other vendors for study-related tasks.
• Perform various study-related functions and assigned to ensure the accurate, quality, timely, and on-budget execution of clinical studies
• Maintaining budget tracking tools as appropriate.
• Performs various administrative duties such as travel arrangements, expense reporting, meeting minutes and other administrative duties for the department

Skills on Resume: 

• Project Management (Hard Skills)
• Reporting (Hard Skills)
• Compliance (Hard Skills)
• Meeting Coordination (Hard Skills)
• Budget Management (Hard Skills)
• Quality Assurance (Hard Skills)
• Administrative Skills (Hard Skills)
• Stakeholder Communication (Hard Skills)

Job Summary: 

• Organise, maintain and complete the paper and electronic trial master files, including the collation of study documents from monitors, and appropriate filing of documents.
• Identify, request and ensure delivery of outstanding and outdated documents.
• Review study files/folders for organization and completeness.
• Assist in setting up clinical study files/folders at study sites and assist in quality review of the study site files/folders throughout the study.
• Assisting by offering support for day-to-day study management activities
• Tracking the distribution of protocols and protocol amendments.
• Creating drafts of study-specific documents.
• Seeking signatures for approved documents.
• Conducting in-house clinical operations functions, including clinical supplies coordination
• Assisting the investigator with meeting preparation and coordination, document processing and study status tracking.

Skills on Resume: 

• Document Management (Hard Skills)
• Attention to Detail (Soft Skills)
• Quality Assurance (Hard Skills)
• Clinical Study Support (Hard Skills)
• Protocol Management (Hard Skills)
• Document Drafting (Hard Skills)
• Document Approval Process (Hard Skills)
• Clinical Operations Coordination (Hard Skills)

Job Summary: 

• Be an essential member of the Trial Team, responsible for the management of trial documentation
• Support the Clinical Trial Managers and Trial Teams in the planning and management of our clinical trials from preparation to reporting and archiving
• Be responsible for the Trial Master Files and for overseeing the CRO maintenance of Trial Master Files following DIA reference models
• Be a superuser and application manager for the Orphazyme eTMF system regarding maintenance, use, training, and access setup
• Work in close collaboration with CROs on relevant plans and TMF filling
• Provide input to and support the continuous development of our document management processes and systems
• Perform quality control of the final TMF and ensure final archiving
• Responsible for appropriate indexing, uploading, and quality control of documents
• Support development and maintenance of procedures/SOPs and working practice and standards for the Clinical Trial Management department and be involved in cross-functional development and update of procedures/SOPs
• Ensure high-quality and timely delivery

Skills on Resume: 

• Trial Documentation Management (Hard Skills)
• Clinical Trial Planning and Management (Hard Skills)
• Trial Master File (TMF) Management (Hard Skills)
• eTMF System Management (Hard Skills)
• CRO Collaboration (Soft Skills)
• Document Management Process Improvement (Hard Skills)
• Quality Control and Archiving (Hard Skills)
• SOP Development and Maintenance (Hard Skills)