LEO Pharma Senior Clinical Research Associate in United States
To monitor (including oversight monitoring of CROs) clinical trial activity at investigator sites.
To ensure the conduct of high quality clinical trials according to ICH-GCP Guidelines, LEO’s international and national Standard Operating Procedures and other regulations and laws as applicable.
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (60% travel with 75% at peak times) to ensure the conduct of high quality clinical trials according to ICH-GCP Guidelines and according to LEO SOPs.
Identify and contribute to a database of potential investigators for participation in clinical trials
Obtain, review for quality and completeness, and process regulatory, ethics and essential documents from investigator sites
Create and maintain appropriate trial-related documentation (including but not limited to the ITF, eTMF, correspondence, visits reports and follow-up letters)
Ensure that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations, and A/E and SAE reporting
Ensure Serious Adverse Events (SAEs) are reported by the site according to the protocol; ensure full SAE reconciliation has been completed at the site level
Manage and report on the progress of the trial at assigned sites
Review and source document verify CRFs and verify other clinical data for completeness and accuracy; generate queries
Resolve queries in the eCRF data with study site personnel
Demonstrate technical competence and assist with user acceptance and implementation of electronic data capture (EDC) at sites
Review tables and listings generated from study data
Consult regularly with the investigator at the site concerning recruitment, retention strategies and other matters relating to the trial
Liaise with the investigator and site staff to ensure open communication, learning and motivation
Identify and be pro-active in dealing with site issues, providing intervention and feedback
Attend local and international training, as required
Assist in the training of other CRAs on monitoring, internal LEO processes and procedures and other duties as required.
Bachelor’s Degree in science or equivalent
Five years’ work experience as a Clinical Research Associate
Thoroughknowledge of ICH-GCP
Excellent written and verbal communications skills
Ability and willingness to travel up to 60% with 75% at peak times
Valid driver’s license and valid passport (or willingness to obtain a passport)
Excellent organizational skills and ability to manage time and work independently and as a team.
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer committed to an inclusive and diverse workforce that creates a better future for our global communities. Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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