Europe

Date:

April 04, 2011

Title:

Clinical Research Associate II

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Chertsey, UK

Experience Required:

Minimum 2 years applicable experience in clinical research, preferably at Clinical Research Associate level. Previous clinical experience of monitoring international phase II/III clinical trials is essential.

Education Level:

Bachelor’s level degree or equivalent qualifications.

Role Purpose/Position Overview

To monitor clinical studies in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard operating procedures (SOPs).

To ensure that clinical study administration, including generation, tracking and filing of study documentation is conducted in compliance with applicable regulatory guidelines and company SOPs.

To contribute to the operational effectiveness of the European Medical department, in collaboration with senior management. 

Key Accountabilities/Responsibilities

To help identify and establish the suitability of study investigators and their investigative sites located outside of the Americas, and to liaise with them to ensure compliance with all necessary study requirements, approvals and agreements (e.g. financial; confidentiality; indemnity).

To initiate, train, monitor and close out investigational study sites and their staff in accordance with company SOPs, GCP and all relevant regulatory requirements.

To establish and maintain a close working relationship with all internal and external (e.g. contractor) clinical research personnel and relevant functional support groups (e.g. data management) across the business. 

To ensure that sites have adequate study supplies in accordance with the relevant study protocol requirements and company SOPs.

To ensure the appropriate tracking, storage and disposition of returned clinical study supplies.

To prepare for, facilitate and act on the audit of study documentation, including investigator, pharmacy, laboratory and sponsor study files.

To ensure the timely reporting of all serious adverse events to the Global Drug Safety department, and the appropriate follow-up, in accordance with company SOPs.

 To assist with generation and review of clinical study documentation as required and ensure that it is distributed and filed in accordance with regulatory guidelines and company SOPs.

To develop a detailed knowledge of all relevant ICH GCP, ethical and regulatory guidelines and legal requirements for the conduct of clinical research.

To develop technical expertise and scientific knowledge by maintaining an up-to-date awareness of relevant scientific literature and by attending and participating in appropriate external scientific meetings.

To compile and file Medical documents in accordance with company SOPs.

May assume the role of a Lead CRA on projects by providing direction and guidance to the project team, coordinating all monitoring activities and communicating the status of these activities to the study manager

To undertake any other tasks appropriate to this position as directed by senior line management of United Therapeutics.

Requirements

Position requires superior verbal and written communication skills as needed, for interactions with vendors, research physicians and associated hospital organizations. Interaction may also include setting up contracts and assuring that commitments in contracts are met.

Position requires ongoing maintenance of budgets and costs associated with clinical trial investigator sites and other contractors, as appropriate.

Excellent communication skills required including a good overall scientific vocabulary.

Fluency in at least one additional European language would be an advantage. 

This is an office-based position, although approximately 50% of time will be spent out of the office (principally within Europe). May fluctuate up or down relative to the status of a given project.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

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