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- Tasks: Support clinical studies and ensure compliance with regulations while collaborating with the trial team.
- Company: Join a dynamic Clinical Operations team focused on advancing medical research and improving patient outcomes.
- Benefits: Enjoy flexible working options, professional development opportunities, and a supportive team culture.
- Why this job: Be part of impactful clinical trials that contribute to groundbreaking medical advancements and patient care.
- Qualifications: 2+ years in clinical studies; knowledge of GCP and strong communication skills are essential.
- Other info: Opportunity for travel and hands-on experience in a fast-paced environment.
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 employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land The Clinical Trial Specialist
✨Tip Number 1
Familiarise yourself with Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs). Understanding these regulations will not only help you in interviews but also demonstrate your commitment to maintaining high standards in clinical trials.
✨Tip Number 2
Network with professionals in the clinical research field. Attend industry conferences or local meetups to connect with Clinical Trial Managers and other specialists. This can provide valuable insights into the role and may even lead to referrals.
✨Tip Number 3
Gain hands-on experience with electronic systems like Trial Master File (TMF) and Clinical Trial Management Systems (CTMS). Familiarity with tools such as Veeva Vault or Smartsheet can set you apart from other candidates and show that you're ready to hit the ground running.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios faced in clinical trials, such as managing site performance or handling deviations. Being able to discuss real-life examples will showcase your problem-solving skills and readiness for the role.
We think you need these skills to ace The Clinical Trial Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical studies, particularly any roles that involved monitoring or coordination. Emphasise your knowledge of Good Clinical Practices (GCP) and any specific software you have used, such as Trial Master File systems.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role of Clinical Trial Specialist. Mention specific experiences that align with the job description, such as managing study documents or supporting clinical trial activities. Show how your skills can contribute to the team.
Highlight Relevant Skills: When detailing your skills, focus on those mentioned in the job description, such as your ability to work independently and in a team, your advanced knowledge of Microsoft Office, and your understanding of clinical trial phases. Use examples to demonstrate these skills.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical trial management.
How to prepare for a job interview at Advanced Clinical
✨Know Your GCP and SOPs
Make sure you have a solid understanding of Good Clinical Practice (GCP) and the relevant Standard Operating Procedures (SOPs). Be prepared to discuss how these regulations apply to your previous experiences in clinical studies.
✨Showcase Your Monitoring Experience
If you have previous site monitoring or study coordinator experience, highlight specific examples during the interview. Discuss any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills.
✨Familiarise Yourself with Study Phases
Understand the different phases of clinical trials and be ready to explain how they relate to clinical development. This knowledge will show that you are well-versed in the clinical trial process and can contribute effectively.
✨Prepare for Team Collaboration Questions
Since the role involves working closely with a team, be ready to discuss your experiences in collaborative environments. Share examples of how you’ve successfully worked with others to achieve common goals, especially in clinical settings.
