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Initiation Clinical Research Associate II

Employer
Parexel
Location
France
Salary
Competitive
Start date
24 Nov 2022
Closing date
10 Dec 2022

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Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for a (Senior) Initiation Clinical Research Associate to behomebased in France.In this role you will act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase specifically. This role specialises in Pre SIV activities /start up tasks of the study.
  • 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.
  • Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include:
    • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
    • Conduct remote Qualification Visits (QVs).
    • 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) in a timely manner.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
  • Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
  • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
  • Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
  • Conduct remote visits/contacts as requested/needed.
  • Assess & manage test article/study supply including supply, accountability and destruction/return status.

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
United Kingdom
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