At a Glance
- Tasks: Support clinical trials by managing documentation and coordinating with sites and vendors.
- Company: Join Parexel, a leader in improving global health through innovative clinical solutions.
- Benefits: Gain valuable experience, competitive salary, and opportunities for professional growth.
- Other info: Collaborative culture focused on empathy and continuous improvement.
- Why this job: Make a real difference in patients' lives while developing your skills in a dynamic environment.
- Qualifications: Degree in life sciences and 2-5 years of relevant clinical trial experience preferred.
The predicted salary is between 30000 - 40000 £ per year.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Country & Site Operational Support
- Execute operational tasks across start-up, conduct and close-out phases.
- Maintain and update trackers, timelines, or task status to support visibility of progress and risks.
- Assist with follow-up on outstanding country or site deliverables and escalate gaps or delays to responsible leads as required.
- Could support coordination with local vendors and CROs by tracking deliverables and ensuring required documentation is received and filed.
- Undertake periodic review of study and site files for completeness and assist with reconciliation activities.
- Maintain site-facing communications, as applicable, to complete assigned work activities.
- Demonstrate a proactive approach to ongoing improvement by consistently seeking opportunities to enhance processes and optimise workflows.
Site Activation Support
- Interactions with sites for collection of documentation needed for Institutional Review Board (IRB), Local Ethics Committee (LEC), Regulatory Authority (RA) submission and Investigator Initiation Packages (IIP) Updates preparation as per country requirements.
- Responsible for preparation of Institutional Review Board (IRB)/Local Ethics Committee (LEC) clinical trial applications by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps.
- Submission to local Regulatory Agency where required.
- Responsible for preparation of Update to Investigator Initiation Packages (IIP) and essential documents by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps.
- Support filing of documents in PTMF, eISF, and document exchange portals, ensuring completeness and correct placement.
- Verify training, financial disclosure, and other required documentation in systems and upload documents received from sites, as applicable.
- Maintain site-facing communications, as applicable, to complete assigned work activities.
Site Contracting Support
- Provide operational support to site contracting activities, including, but not limited to, site contract and budget preparation, site-facing negotiation, status tracking, and the coordination of workflows required for site contract finalization, execution and filing.
- Maintain site-facing communications from document preparation through the execution and filing of site contracts.
- Responsible for maintaining accuracy and completeness of site contracting systems and related trackers (as applicable) for assigned work.
Education
- BS/BA or bachelor’s degree in life sciences or a related discipline is an asset.
Experience
- 2-5 years of relevant experience in clinical trial support, site activation, or clinical operations (pharmaceutical company or CRO preferred).
- Exposure to country or site-level clinical trial operations and supporting documentation workflows.
- Experience supporting contracting, regulatory, or vendor-related documentation processes is an advantage.
GCO Associate I - FSP employer: Parexel
At Parexel, we pride ourselves on fostering a collaborative and empathetic work culture that empowers our employees to make a meaningful impact on global health. With a strong commitment to professional development, we offer numerous growth opportunities and support for continuous learning, ensuring that every team member can thrive in their role. Located in a vibrant area, our office provides a dynamic environment where innovation and teamwork are at the forefront of our mission to improve patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land GCO Associate I - FSP
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Parexel. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Parexel.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Parexel. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Parexel is looking for. A tailored application can really make you stand out!
We think you need these skills to ace GCO Associate I - FSP
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Parexel!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Parexel that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Parexel!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Parexel, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Parexel
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Parexel that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Parexel’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
