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Initiation Clinical Research Associate I

Employer
Parexel
Location
Istanbul, Turkey
Salary
Competitive
Start date
10 Jun 2024
Closing date
19 Jun 2024

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Job Details

The Initiation Clinical Research Associate I (iCRA I) specialises 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 I can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.

This role offers a hybrid working model and can be based in Istanbul or Ankara.

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 start-up 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 site-specific 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.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • 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 problem-solving 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 the English language.
  • 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 would be desired, but it's not necessary as the training on the job will be provided.


Education:
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience as a Clinical Study Coordinator or Clinical Nurse.


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

Company

parexel

When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

How to describe Parexel’s culture in one word: 

Henry

 

 

Working With Heart™ - Christina's perspective:

Working With Heart™ - Christina's perspective:

 

Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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