Senior Clinical Research Associate

vor 5 Monaten

Hamburg, Deutschland TFS HealthScience Vollzeit

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.

**Join Our Team as a** **Senior Clinical Research Associate (Snr CRA)** - (home based in Germany).**

**About this role**

As part of our **Clinical Operations **team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The **Senior Clinical Research Associate (Snr CRA)** will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to
company policies, SOPs and regulatory requirements.
The **Senior Clinical Research Associate (Snr CRA)** may assist the Project Manager in certain aspects of project activities which may include project tracking, monitoring plans, review of monitoring reports and CRA resources management.
The **Senior Clinical Research Associate (Snr CRA)** may also conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed; may involve overnight and international travel.

**Key Responsibilities**:

- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
- Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
- Initiates corrective action to resolve issues as directed by supervisor
- Participate in contract handling and negotiation directed by Lead CRA/Project Manager
- Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
- In cooperation with study team, responsible for SMF maintenance

**Qualifications**:
Bachelor’s Degree, preferably in life science or nursing; or equivalent
3-5 years of experience as CRA including relevant on-site monitoring 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 independently as well as in a team matrix organization
Excellent written and verbal communication skills
Excellent organizational skills
Ability and willingness to travel up to 60-70%

**What We Offer**

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

**A Bit More About Us**

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

**#Together we make a difference

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