Clinical Trials Specialist

1 week ago

London, Greater London, United Kingdom Pharmaceutical Research Associates, Inc Full time

Overview

About Pharmaceutical Research Associates, Inc.

We are a global clinical research organization dedicated to advancing healthcare through innovative solutions. Our team of experts is committed to delivering high-quality services that meet the evolving needs of our clients.

Job Description

Clinical Trials Specialist - Global Clinical Operations

This role involves providing support for clinical trial management, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to deliver study-related activities.

Responsibilities
  • Manage all documents and logistical tasks related to trial feasibility, start-up, execution, and close-out.
  • Evaluate trial-related activities against GCO SOPs, policies, and local regulatory requirements.
  • Review technical regulatory documents, including Informed Consent Forms.
  • Partner with Clinical Trial Managers and CRA's to ensure overall site management while performing trial-related activities for assigned protocols.
  • Support protocol-specific training process and manage forms used to track, administer, and document completion of protocol-specific training.
  • Evaluate study-related activities against Global Development SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), and local regulatory requirements.
  • Filing and maintenance of training materials in the Clinical Trial Learning & Development Training Library and the Trial Master File System at the direction of the Therapeutic Area (TA) Lead(s).
Deliverables:
  • All services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
  • Track progress of the clinical trial, manage study data, budget, investigational products, mailings, and correspondence, and other relevant tasks in support of the CTM and CRA.
  • Collect and file all documents throughout the trial and post-trial (GCO) or protocol-specific training related documents (CTL&D).
  • Evaluate audit and inspection readiness.
  • Collect and track financial disclosure information at appropriate timepoints in accordance with procedural documents.
  • Prepare study files for investigational sites and coordinate the development of associated documents and review them for completeness and accuracy.
  • Provide updates to study-specific internal data repositories to ensure availability of trial documents to the study team.
  • Manage study budget, including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.
Requirements
  • Degree in life sciences.
  • Minimum 1-2 years of previous proven CTA experience in a CRO or Pharmaceutical environment.
Compensation and Benefits

The estimated annual salary for this role is $65,000 - $85,000, depending on qualifications and location. We offer a comprehensive benefits package, including various annual leave entitlements, health insurance offerings, competitive retirement planning, and more.

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