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For Companies At a Glance
- Tasks: Coordinate and manage clinical studies from start to finish, ensuring smooth operations.
- Company: Join a leading organisation in the life sciences sector with a focus on innovation.
- Benefits: Gain valuable experience, competitive pay, and opportunities for professional growth.
- Other info: Collaborative team culture with opportunities to learn and grow in the clinical research field.
- Why this job: Make a real difference in healthcare while developing your skills in a dynamic environment.
- Qualifications: Administrative experience, strong organisational skills, and proficiency in English required.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Key Accountabilities
- Trial and Site Administration: Assists in coordination and administration of clinical studies from the start-up to execution and closeout. Serves as local administrative main contact and works closely with the CRAs and/or the Local Study Associate Director (LSAD) for the duration of the study. Sets up, populates and accurately maintains information in Client tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc.) and supports others in the usage of these systems. 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 websites.
- Document Management: Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (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. 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 emails. Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
- Regulatory and Site Start Up Responsibilities: 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. Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the Client’s 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.
- Budgeting, Agreements and Payments: Prepares and/or supports contract preparation at a site level. Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
Skills (Essential)
- Proven organizational and administrative skills.
- Computer proficiency.
- Proficient in written and spoken English language required.
Skills (Desirable)
- 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.
- 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.
Knowledge and Experience (Essential)
- Previous administrative experience preferably in the medical/life science field.
Knowledge and Experience (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.
Education
- High school/Secondary school qualifications (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. Further studies in administration and/or in the life science field are desirable.
Clinical Study Administrator - FSP employer: Parexel International
Contact Detail:
Parexel International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Study Administrator - FSP
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical study field, attend relevant events, and don’t be shy about asking for introductions. You never know who might have the inside scoop on job openings.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their clinical study processes. Be ready to discuss how your skills align with their needs, especially in trial administration and document management.
✨Tip Number 3
Showcase your organisational skills during interviews. Bring examples of how you’ve managed multiple tasks or projects in the past, especially in high-pressure environments. This will demonstrate your ability to thrive in a fast-paced role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Clinical Study Administrator - FSP
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in clinical study administration. We want to see how your skills match the key accountabilities listed in the job description!
Show Off Your Organisational Skills: Since this role requires excellent organisational abilities, give us examples of how you've successfully managed multiple tasks or projects in the past. We love a good story about keeping things on track!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. Use clear language and avoid jargon unless it's relevant to the role. We appreciate clarity just as much as you do!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Parexel International
✨Know Your Stuff
Make sure you understand the clinical study process and the specific responsibilities of a Clinical Study Administrator. Brush up on ICH-GCP guidelines and be ready to discuss how your previous experience aligns with the key accountabilities listed in the job description.
✨Show Off Your Organisational Skills
Since this role requires excellent organisational abilities, prepare examples that showcase your skills in managing multiple tasks and maintaining attention to detail. Think about times when you successfully coordinated projects or managed documentation under tight deadlines.
✨Familiarise Yourself with Tools
Get comfortable with tools like CTMS, SharePoint, and any other relevant software mentioned in the job description. If you have experience with these systems, be ready to share how you used them effectively in past roles.
✨Communicate Clearly
As communication is key in this role, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've liaised with different stakeholders in previous positions and how you can contribute to effective team collaboration.