Initiation Clinical Research Associate Ii - Uxbridge, United Kingdom - Parexel

Parexel

Verified Company

Uxbridge, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

We are currently looking for an Initiation Clinical Research Associate II to join our UK Clinical Study Start-Up Team in Uxbridge.
The
Initiation Clinical Research Associate (
iCRA) specializes in performing all study start up activities for a clinical trial.

You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study.

The iCRA II can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.

Key Accountabilities:

Start-Up (from site identification through pre-initiation)

Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the startup phase.
Build relationships with investigators and site staff.
Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or sitespecific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
Forecast, develop, manage, and revise plans and strategies for:
IRB/IEC and MoH / RA submission/approval,
Site activation,
Patient recruitment & retention.
Update and maintain appropriate Clinical Trial Management systems (CTMS).

Skills:

Strong problemsolving skills.
Able to take initiative and work independently, and to proactively seek guidance when necessary.
Client focused approach to work.
Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
Fluent command of English.
Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
Excellent time management to meet study needs, team objectives, and department goals.

Knowledge and Experience:

Previous experience in study set up / site initiation / study start up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology.
Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable.

Education:

Educated to degree level (biological science, pharmacy, or other healthrelated discipline preferred) or equivalent nursing qualification or other equivalent experience.

If you are ready to join Parexel's Journey, please apply
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