Clinical Research Associate

TFS HealthScience

7d•Hybrid

About The Position

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 Clinical Research Associate (Freelance, 0.3 FTE) About this role As part of our Clinical Development Services (CDS) team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Clinical Research Associate (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, GCP and ICH guidelines, sponsor requirements, and applicable regulatory requirements.

Requirements

Bachelor's Degree, preferably in Life Sciences, Nursing, or equivalent.
Minimum 1 year of relevant clinical research experience or relevant academic background related to clinical trials or clinical development activities.
Understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
Strong written and verbal communication skills with fluency in English.
Excellent organizational skills and ability to work independently as well as within a matrix team environment.

Responsibilities

Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP and ICH guidelines, and applicable regulatory requirements.
Perform all required monitoring activities at study sites to ensure subject safety, data integrity, and quality.
Verify the protection of study participants through informed consent procedures and protocol compliance in accordance with regulatory requirements.
Review CRFs (electronic or paper) and subject source documentation for validity, completeness, and accuracy.
Verify proper management and accountability of Investigational Product.
Prepare timely monitoring visit reports, document findings and follow-up actions, update required tracking systems, and escalate issues as appropriate.
Ensure site documentation is maintained appropriately, support eTMF and ISF compliance, and update CTMS and other required project systems with accurate site information.