Clinical Research Associate

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.

As part of our SRS / FSP team, you will be dedicated to one sponsor, a global biotech company that is an industry leader in onco-hematology.

Key Responsibilities

• Monitor on-site and remotely clinical trials in accordance with TFS and / or client company Standard Operating Procedures, FDA regulations, GCP, and ICH guidelines.
• Review CRFs (paper or electronic) and subject source documentation for validity and accuracy, generating queries to investigational sites / clients to resolve data issues.
• Identify site problems / deficiencies and report to management through trip reports, memos, and verbal communication with Project Manager or Lead CRA.
• Initiate corrective actions as directed by supervisor.
• Contribute to the completion of applications to Ethics Committees / IRBs, preparing necessary documentation in cooperation with CTA and under the guidance of Lead CRA / Project Manager.
• Participate in contract handling and negotiation as directed by Lead CRA / Project Manager.
• Set up ISF and SMF (or cooperate with CTA) and distribute to investigational sites.
• Maintain SMF in cooperation with the study team.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
• Update CTMS system with site and study information.
• May audit data in tables and text of clinical summaries.
• Assist in preparing study documentation such as CRF Completion Guidelines, patient diaries, and study participation cards, ensuring accuracy and completeness.
• Prepare check requisitions for sponsor Project Manager approval, when applicable.

Qualifications

What We Offer

We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. Join a team that values collaboration, innovation, and making a difference in patients' lives.

About Us

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service, global CRO with solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. With over 800 professionals in more than 40 countries, our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and company culture.

Our benefits include health insurance, lunch allowance, flexible remuneration, overtime compensation, summer working hours, and flexibility.

We’re committed to making a difference — together.

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