Clinical Research Associate 0.3 FTE

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 Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions (SRS) within TFS HealthScience and will function operationally as a member of a Project Team. The CRA is responsible for the initiation on-site and/or remote monitoring and close-out of study sites during study conduct in accordance with company policies SOPs GCP and ICH guidelines and other regulatory requirements.

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 study sites to assess and ensure subject safety data integrity and quality.

• Verify the protection of study participants through 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 the Monitoring Visit Report including findings corrective and preventive actions already taken and updates to applicable tracking systems; escalate observed deficiencies and issues as appropriate.

• Provide sites with a listing of issues identified during monitoring visits and action items to be addressed in a timely manner.

• Timely deliver site documents to eTMF or paper TMF; verify that the Investigators Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.

• Participate in audit and/or inspection preparation and follow-up activities as needed.

• Order ship and reconcile clinical investigative supplies for study sites if applicable.

• Update CTMS and all other project-required systems with accurate site-level information.

Qualifications

• Bachelors Degree preferably in life science or nursing; or equivalent.

• 1 year of relevant clinical experience or relevant academic background in clinical trial or clinical development activities.

• Ability to work in a fast-paced environment with changing priorities.

• Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas.

• Knowledge of Good Clinical Practice (GCP) regulations and ICH guidelines.

• Ability to work independently as well as within a team matrix organization.

• Strong written and verbal communication skills; fluent in English.

• Excellent organizational skills and technology proficiency including software and computer skills.

• Core soft skills: self-awareness flexibility proactivity collaborative mindset analytic approach and attention to detail.

• Ability and willingness to travel up to 60-80% including overnight and international travel where applicable.

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.