Company: Lab Support
Closing Date: 15 Dec 16
Salary (£): Competitive
enior Clinical Research Associate, Middlesex, 12 month contract, competitive salary
Senior Clinical Research Associate, Middlesex, 12 month contract, competitive salary
Our client, a global biopharmaceutical company, are looking to recruit an experienced Clinical Research Associate to join their team.
· Monitor assigned clinical sites and ensure compliance of assigned studies with national and international regulatory requirements.
· Conduct pre-study, initiation, interim monitoring and close-out visits.
· Train assigned investigative sites in GCP and assure these sites are conducting research according to protocol and national laws.
· Review investigative sites’ regulatory documentation and ensure compliance with GCP.
· Monitor informed consent process.
· Serve as main point of contact with assigned investigative sites.
· Review and update clinical files at assigned investigative sites.
· Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP.
· Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of what happened to a subject while participating in the study.
· Create and properly file trip reports, follow-up letters and telephone contacts for assigned investigative sites.
· Evaluate and resolve Data Queries.
· Evaluate study query trends and interact with study team in improving data quality.
· Assist investigative site with the timely and accurate resolution of queries.
· Attend, participate and present at investigator meetings, as requested.
· Effectively negotiate and manage clinical study budgets for assigned investigative sites.
· Identify new investigators for future studies.
· Assist in the review of draft Case Report Forms and Protocols, as requested.
· Participate in study and clinical team meetings. Communicate clinical performance data to other members of the management and scientific team.
· Assist in mentoring new CRAs, as requested.
· Up to approximately 80% site monitoring including travel with possible overnight stays.
· Involved in affiliate CRO oversight activities as directed by CRM or CRD.
Lab Support UK Shire Park 2 Falcon Gate Welwyn Garden City Hertfordshire
|Tel:||00 +44 (0)1727 808930|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.