Clinical Study Team Assistant - UK (Home-Based) - FSP

Parexel are currently recruiting for a Clinical Study Team Assistant in the UK.

Job Summary:

The Clinical Study Team Assistant (CSTA) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for multiple tasks that span from study start up to study close out which enables the efficient execution of clinical trials to high quality standards.

Key Accountabilities:

• Responsible for providing study level operational support to the study team from study start up to close out and submission. Tracks and oversees study information; follows up with functional lines as needed.

• Maintenance and oversight of study team shared spaces. Maintains and oversees Study Team on Demand (STOD).

• Trial Master File (TMF) maintenance, compliance, and oversight.

• Maintains client registries and systems as required to ensure compliance.

• Liaises with cross functional study team members: Initiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systems.

• Provides study level reporting to support management of clinical trial data, clinical trial budget and timelines.

• Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission.

• Supports engagement of Independent Oversight Committees.

• Provides support with audit and inspection readiness activities.

• Assists with oversight and tracking of clinical trial budget spend.

• Provides logistical and operational support for Investigator Meetings.

• Coordinates the translation of documents as required.

• Provides status updates on key tasks and contributes to study team meetings.

• Provides support to study teams with system setup and maintenance.

• May provide support for global study team communications to sites.

Skills and Experience:

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS).

• Effective verbal and written communication skills.

• Fluency in written and spoken English required.

• Ability to work independently but also as part of a larger team with limited support from supervisor; ability to multitask and manage multiple competing priorities.

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality.

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving and decision-making skills; seeks input from others when faced with a difficult situation; makes sound decisions within the scope of responsibility.

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.

Education:

• Bachelor’s degree with 2 years’ experience, or master’s degree or MBA.

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