Zenith LifeScience · 3 hours ago
Clinical Study Administrator
Wilmington, DE
Contract
Onsite
New Grad, Entry LevelZenith LifeScience is focused on clinical study management, and they are seeking a Clinical Study Administrator to assist in the coordination and administration of clinical studies. The role involves managing study activities from start-up to close-out, ensuring compliance with regulatory requirements and maintaining essential study documents.
Clinical TrialsConsultingLife SciencePharmaceuticalProduct Research
Responsibilities
Assists in coordination and administration of clinical studies from the start-up to execution and close-out
Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study
Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents
Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study
Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF
Contributes to the production and maintenance of study documents, ensuring template and version compliance
Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ERV) ensuring compliance with the Company Authoring Guide for Regulatory Documents
Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
Sets-up, populates and accurately maintains information in Company tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems)
Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts)
Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations
Manages and contributes to coordination and tracking of study materials and equipment
Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes
Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites
Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required
Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails
Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material
Ensures compliance with Company’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
Ensures compliance with local, national and regional legislation, as applicable
Additional country-specific tasks might be added depending on local needs
Qualification
Required
Level of education that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers
Previous administrative experience preferably in the medical/ life science field
Proven organizational and administrative skills
Computer proficiency
Good knowledge of spoken and written English
Assists in coordination and administration of clinical studies from the start-up to execution and close-out
Collects, assists in preparation, reviews and tracks documents for the application process
Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study
Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents
Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study
Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF 'Inspection Readiness'
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF
Contributes to the production and maintenance of study documents, ensuring template and version compliance
Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ERV) ensuring compliance with the Company Authoring Guide for Regulatory Documents
Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
Sets-up, populates and accurately maintains information in Company tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems
Prepares and/or supports contract preparation at a site level
Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations
Manages and contributes to coordination and tracking of study materials and equipment
Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors' meetings, Investigators' meetings
Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites
Responsible for layout and language control, copying and distribution of documents
Supports with local translation and spell checks in English to/from local language, as required
Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails
Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material
Ensures compliance with Company's Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
Ensures compliance with local, national and regional legislation, as applicable
Preferred
Further studies in administration and/or in life science field are desirable
Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines
Ability to develop advanced computer skills to increase efficiency in daily tasks
Good verbal and written communication
Good interpersonal skills and ability to work in an international team environment
Willingness and ability to train others on study administration procedures
Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
Integrity and high ethical standards
Company
Zenith LifeScience
Zenith LifeScience is a consulting company that specializes in clinical trials, research, pharmacovigilance, and regulatory compliance.
51-200 employees
H1B Sponsorship
Zenith LifeScience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (10)
2023 (3)
2022 (14)
2021 (4)
2020 (4)
Funding
Current Stage
Growth StageCompany data provided by crunchbase