Junior Clinical Research Associate (Extracurricular Internship)
Job Summary
About this role
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.
The Junior Clinical Research Associate is responsible for for the initiation on-site and remote monitoring and termination of investigative sites during study conduct according to company policies SOPs and regulatory requirements.
As part of our SRS/FSP team you will be dedicated to one sponsor a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
Key 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 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 informed consent procedures and protocol requirements that 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.
Qualifications
Bachelors Degree in life science or nursing; or equivalent
0-1 years of experience as CRA including internship experience
Able to work in a fast-paced environment with changing priorities.
Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations ICH guidelines.
Ability to work with certain autonomy as well as in a team matrix organization.
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration quality and making a difference in the lives of patients.
Our core values of Trust Quality Passion Flexibility and Sustainability guide our decisions and shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden in the city of Lund. As a full-service global CRO we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more