At a Glance
- Tasks: Support clinical studies and ensure compliance with Good Clinical Practice.
- Company: Join a dynamic Clinical Operations team focused on innovative healthcare solutions.
- Benefits: Enjoy flexible working options and opportunities for professional growth.
- Other info: Travel may be required; strong communication skills are essential.
- Why this job: Be part of impactful clinical trials that shape the future of medicine.
- Qualifications: 2+ years in clinical studies; nursing or science degree preferred.
The predicted salary is between 36000 - 60000 £ per year.
The Clinical Trial Specialist (CTS) will be a member of the Clinical Operations team.
This role is at the Coordinator/Associate CTM level
- They will have the following key responsibilities: Support moderately complex clinical study activities in support of the Clinical Trial Manager.
- Work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP\'s.
- May assist with vendor oversight and management with guidance.
- Identify issues in a timely manner and escalate to management as appropriate.
- May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.
Essential Functions
- Support Phase 1, 2, 3 and 4 clinical studies with guidance.
- Support activities related to study/site feasibility, start-up, maintenance, and close-out.
- Manage study and site essential document review, collection, tracking, etc., from study start-up through maintenance and close-out.
- With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable (including but not limitedto Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.)
- Study Trial Master File (TMF) oversight.
- Ensure that the required study documents are received, reviewed, and filed in the TMF in accordance with SOPs, GCP, and applicable regulations.Organise study-related meetings, including but not limited to the preparation of the agenda/ minute taking, and maintenance of risk/ issue/ decision logs.
- May lead and present at study-related meetings.
- May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring, close-out visits).
- Provides rapid action to address both internal and site QA findings from audits.
- May manage, coordinate, and oversee the activities from third-party vendors, including deliverables metrics, accruals, process planning, and implementation.
- General study tracking and maintenance, including but not limited to study status, enrolment, site queries, deviations, study levels documents and plans, etc.
- Study site oversight, including but not limited to site performance, metrics, monitoring report review, etc.
- Assist and support study data-related activities, including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
- Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).
- Work cross-functionally and provide oversight of CRO and vendor activities, including vendor management as assigned.
- Review and verification of contracted vendor activities,s including vendor invoice review.
- Support study reporting and tracking with applicable systems and technology.
- Support study leads in the cross-functional alignment of study timelines.
- Required Knowledge, Skills, and Abilities: At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred).
- Previous site monitoring or study coordinator experience is preferred.
- Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
- Understanding of study phases and general knowledge of how they apply to clinical development.
- Demonstrated ability to work independently and in a team environment.
- Advanced knowledge of Word, Excel, and PowerPoint.
- Working knowledge of electronic Systems, including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
- Knowledge of the principles and practices of computer applications in database management.
- Strong verbal and written communication skills required.
- Travel of 10% to 20% may be required.
Required/Preferred Education and Licenses:
- BA/BS, nursing degree or equivalent required, science major preferred.
- Relevant clinical trials experience is preferred.
The Clinical Trial Specialist in Cambridge employer: Advanced Clinical
As a Clinical Trial Specialist, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. Our company fosters a culture of collaboration and innovation, offering comprehensive training and mentorship opportunities to enhance your skills in clinical operations. Located in a vibrant area, we provide a range of benefits including flexible working arrangements, health and wellness programmes, and the chance to contribute to groundbreaking clinical research that makes a real difference in patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land The Clinical Trial Specialist in Cambridge
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We think you need these skills to ace The Clinical Trial Specialist in Cambridge
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 Advanced Clinical!
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 Advanced Clinical 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 Advanced Clinical!
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 Advanced Clinical, 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 Advanced Clinical
✨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 Advanced Clinical 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 Advanced Clinical’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.
