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Senior Clinical Research Associate

Created 02/23/2021
Reference oXGHefwi
Category Medical Scientists
Job type Full Time
Country United States
Zip Not specified
Salary Competitive
Description

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.

Required Experience:
  • Bachelor's Degree in science or equivalent
  • Five years' work experience as a Clinical Research Associate
  • Thorough knowledge 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.

EEOC
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.

Please note:
LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels: the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com" screening and interaction by telephone and through the Microsoft Teams platform.

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Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.

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If you have any questions about LEO Pharma Inc. and the application process, please email the company's U.S. People and Communications team at [email protected]