(Senior) Clinical Research Associate

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 (Senior) Clinical Research Associate (CRA) will function operationally as a member of a Project Team and is responsible for the initiation onsite and/or remote monitoring close out of study sites during study conduct according to company policies SOPs and GCP and ICH guidelines and other 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.

• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.

• Timely delivering 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 its preparation and follow-up activities as needed.

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

• Update CTMS and all other required by projects systems with accurate site level information

Qualifications

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

• Must have at least 3 years of oncology monitoring experience including a minimum of 1 year in Phase I/II oncology studies.

• Strong GCP/ICH knowledge.

• Fluency in English.

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

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

• Strong written and verbal communication skills.

• Excellent organizational skills

• Technology savvy and good software and computer skills

• Soft skills: Self-awareness resolute flexibility proactivity collaborative mindset analytic approach and attention to detail

• Ability and willingness to travel up to 60-80%

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.