Clinical Study Specialist / Snr CTA - FSP - Remote

REGISTER YOUR INTEREST IN AN UPCOMING ROLE.

Parexel is beginning to search for an experienced Clinical Trial Administrator to join one of our key sponsors in the UK as a Clinical Study Specialist.

In this role you will provide technical and administrative support to the clinical study teams responsible for clinical trial execution.  The CSS may be assigned to support the execution of one or more studies across a program.

Some specifics about this advertised role

• Organizes and delivers reports and metrics to the clinical study lead.
• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
• Collates data for assessments such as feasibility and site selection and reviews site usability database.
• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures.
• Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders.
• Collates materials for training and investigator meetings.
• Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan.
• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings.
• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance.

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.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Bachelor’s degree (or equivalent) and a minimum of 2+ years’ industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred.
• Attention to details for the ability to track information and deliver on assigned study activities
• Good communication and interpersonal skills; ability to build relationships internally and externally
• Ability to be resourceful and to demonstrate problem solving skills
• Demonstrate the ability to proactively assess information and investigate impact on clinical trials
• Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP