TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Senior CRA About this role As part of our Strategic Resourcing Solutions team, you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Senior CRA is responsible for the initiation, on-site and/or remote monitoring, and close out of study sites during study conduct, according to company policies, SOPs, and regulatory requirements.
Key Responsibilities: Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP, ICH guidelines, and applicable regulatory regulations.
Perform all required monitoring activities at the study sites to assess and ensure subjects' safety, data integrity, and quality.
Verify the protection of study participants by ensuring informed consent procedures and protocol requirements follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy.
Verify proper management and accountability of Investigational Product.
Timely reporting of actions taken during monitoring visits in Monitoring Visit Report, including findings, corrective and preventive actions already taken, and update applicable tracking systems as required; escalate observed deficiencies and issues as appropriate.
Provide the site with a listing of issues identified during monitoring visits and action items that need to be addressed in a timely manner.
Timely deliver site documents to eTMF or paper TMF.
Qualifications: Bachelor's Degree, preferably in life science or nursing; or equivalent.
3+ years of experience as CRA, including relevant on-site monitoring experience.
Able to work in a fast-paced environment with changing priorities.
Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess an understanding of Good Clinical Practice regulations and ICH guidelines.
Ability to work independently as well as in a team matrix organization.
Excellent written and verbal communication skills.
Fluent in English.
What We Offer We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
A Bit More About Us Our journey began over 27 years ago in Sweden, in the city of Lund.
As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future.
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