Senior Clinical Research Associate (Senior CRA) - Remote

Overview

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic professional to join our in-house team as a Senior Clinical Research Associate (Senior CRA) on a permanent basis. You will be working on 2-3 trials, where you will be responsible for site management (including start-up), both on-site and remotely, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

In Short

• Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
• Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
• May act as Feasibility Associate.
• Train site staff in all study procedures.
• Conduct periodic monitoring visits, including completion of monitoring visit report.
• Conduct source data verification and in-house review of clinical data.
• Manage the investigational products and trial material.
• Cooperate with the site staff to ensure proper reporting from the site for safety issues.
• Conduct and report study termination and related activities.
• Act as the main contact person for the site.

Requirements

• University Degree in scientific, medical or paramedical disciplines.
• Proven experience as a CRA, performing on-site monitoring activities.
• Experience with oncology or respiratory trials is required.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Fluent in English and local language(s).
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel.

Benefits

• Excellent work-life balance.
• Collaborative “one-team” culture.
• Opportunity to make a difference in people's lives.
• Professional development opportunities.