Clinical Trial Specialist - UK (Remote) - FSP

Parexel; Uxbridge; Remote; GBP 30,000 - 45,000; Full time

Job summary

A major pharmaceutical company is seeking a Clinical Trial Specialist in Uxbridge for a remote position. The role involves supporting clinical studies and ensuring compliance with Good Clinical Practice. The ideal candidate will have a relevant degree and at least two years of experience in clinical trials, providing a chance to work with leading global biotechs.

Qualifications

• Bachelor’s degree or nursing degree required, science preferred.
• 2+ years of experience in clinical studies required.
• Working knowledge of Good Clinical Practices (GCP) required.

Responsibilities

• Manage study and site essential document review and collection.
• Support activities related to study feasibility, start-up, and maintenance.
• Perform applicable site monitoring and oversight visits.

Skills

Communication

Teamwork

Time Management

Education

Bachelor's degree or equivalent

Tools

Trial Master File

CTMS

Job description

Clinical Trial Specialist - UK (Remote) - FSP

Parexel Uxbridge, England, United Kingdom

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Clinical Trial Specialist - UK (Remote) - FSP

Parexel Uxbridge, England, United Kingdom

Join to apply for the Clinical Trial Specialist - UK (Remote) - FSP role at Parexel

Parexel is currently seeking a Clinical Trial Specialist to join us in the UK, dedicated to a single sponsor.

This role will be responsible for supporting the Clinical Trial Manager and the wider clinical trial team to ensure activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's and helping to identify issues in a timely manner and escalate to management as appropriate.

It may involve assisting with vendor oversight and management and completing monitoring visit report reviews and occasionally performing co-monitoring or monitoring oversight visits.

Working as a Clinical Trial Specialist at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• 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.
• Study Trial Master File oversight, review and filing.
• Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs. (Occasionally this may involve leading and presenting 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 and 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.).
• Review and verification of contracted vendor activities including vendor invoice review.
  
  

Here are a few requirements specific to this advertised role.

• Bachelor’s, nursing degree or equivalent required, science preferred.
• 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.
• 10% - 20% travel may be required.
  
  

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who Are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care

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