Research Operations Specialist
hace 4 semanas
About TFS HealthScience
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.
We are seeking a highly skilled Research Operations Specialist to join our team. The ideal candidate will work alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Research Operations Specialist 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.
Responsibilities:
You will be responsible for:
- Monitoring on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP, ICH guidelines, and applicable regulatory regulations.
- Verifying the protection of study participants by ensuring informed consent procedures and protocol requirements follow appropriate regulations.
- Reviewing CRFs (electronic or paper) and subject source documentation for validity and accuracy.
- Verifying proper management and accountability of Investigational Product.
- Reporting actions taken during monitoring visits in Monitoring Visit Report, including findings, corrective and preventive actions already taken, and updating applicable tracking systems as required.
- Providing the site with a listing of issues identified during monitoring visits and action items that need to be addressed in a timely manner.
- Delivering site documents to eTMF or paper TMF.
Requirements
To succeed in this role, you will need:
- 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.
- Understanding of basic medical terminology and science associated with the assigned drugs and therapeutic areas.
- Possessing 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.
Estimated Salary: $75,000 - $95,000 per year
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