Our client is global leader in pharmaceutical development produces a broad range of imaginative and innovative solutions for hitherto unmet medical needs that enhance people''s health and quality of life. They are seeking a Clinical Research Associate (CRA) for a 6 month contract at their UK location.
The Clinical Research Associate will be responsible for performing study site management activities related to start up activities, regulatory compliance, patient enrolment, protocol adherence, CRF compliance and data quality for clinical trials so that they meet specified scientific, medical, regulatory and commercial needs as well as developing and maintaining investigator relationships.
PRINCIPAL RESPONSIBILITIES include:
Contributes to the site and investigator selection process for their area of responsibility
Evaluates site facilities and staff to ensure that investigative site meets necessary guidelines and regulations
Ensures all required study start-up documentation is in place and the site is able to start on time and according to plan
Conducts on-site visits and monitoring activities in line with the monitoring plan
Perform SDV during on-site monitoring visits according to the protocol SDV plan
Evaluates site recruitment activities
Assesses ongoing training needs of all site personnel
Performs site-level drug accountability and reconciliation activities
Assists in implementing country-level communication plan for study sites and executes the site communication plan
Performs & facilitates study start-up activities with the investigational site to ensure all the necessary
arrangements are in place prior to study conduct
Develops and implements site recruitment plan with input from investigator
Carries out monitoring activities at the site during the study start-up phase
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
BSc in Science/ medicine
Experience as CRA
Previous pharmaceutical /CRO experience
Fforde is acting as a recruitment agency/business.
KEY WORDS: Clinical Research, CRA, Clinical Monitoring, Clinical Trials, Clinical Study, Degree, Life Science, CRO, Pharmaceutical, Study Startup, Regulatory, UK
Posted: 15/08/2012 | NPJ Ref: 85075