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Job Details

Clinical Research Associate - Single Sponsor Dedicated - UK Homebased

Company: IQVIA
Location: UK wide
Reference: R1024527
Closing Date: 26 Oct 18
Type: Full Time
Salary (£): Competitive
Benefits: Competitive package

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Job Summary:

Join us on our exciting journey! Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. A career with IQVIA connects you to great opportunity to achieve professional success and impact healthcare around the world.

Requirements:

We are currently looking for the experienced CRAs to join our single sponsor dedicated model.

Key Points
• Single sponsor, client facing role in IQVIA single sponsor department
• True partnership between IQVIA and the sponsor with a good culture
• CRA/SCRA would be allocated to 1-2 protocols
• Approximately 10 sites allocated to each CRA/SCRA (10 in total, not per protocol)
• The sponsor model has reduced travel (approximately 30% or less), this is due to using ‘Fit for Purpose monitoring’ which incorporates remote monitoring. Therefore there is less need for on-site visits.
• All CRA/SCRAs allocated a dedicated IQVIA line manager.
• All CRAs will be permanent IQVIA staff.
• CRAs/SCRA work directly with the sponsor Country Study Management team
• Ethics/Regulatory submissions are completed centrally by sponsor’s study start up group.
• Flexi working with 10 – 4 being core office hours


Responsibilities
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.

Required Knowledge, skills and abilities
• In depth knowledge and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• In depth therapeutic and protocol knowledge as provided in company training
• Strong written and verbal communication skills including good command of English language
• Excellent organizational and problem-solving skills
• Effective time management skills
• Ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients


Minimum Required Education & Experience
Bachelor's degree in a health care or other scientific discipline or educational equivalent and a minimum of 3 years of on-site monitoring experience; or equivalent combination of education, training and experience

Apply for this job: Clinical Research Associate - Single Sponsor Dedicated - UK Homebased

Contact Information:

Address:  Reading Office
500 Brook Drive Green Park Reading Berkshire
RG2 6UU
England
Tel:  +44 (0) 1184 508000
Website:  Visit Our Web Site

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