Senior Clinical Research Associate mfd

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities 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 Operationsteam 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 onsiteand 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 includeproject 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 prestudy initiation interimand closeout). Ability to travel as needed; may involve overnight and international travel.

Key Responsibilities:

• Monitor onsite and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures FDA regulations and GCP and ICH guidelines
• Review CRFs (paper or electronic) and subject source documentation for validity andaccuracy and generate queries to investigational sites/clients to resolve problem data
• Identify site problems/deficiencies and bring to the attention of management through tripreporting memos and verbal communication with Project Manager or Lead CRA
• Initiates corrective action to resolve issues as directed by supervisor
• Contribute to the completion of the application to Ethics Committee/IRB prepare necessarydocumentation enclosed to the application according to local requirements in cooperationwith CTA and directed by Lead CRA/Project Manager
• 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:

Bachelors Degree preferably in life science or nursing; or equivalent
35 years of experience as CRA including relevant onsite monitoring experience
Able to work in a fast paced environment with changing priorities
Understand the basic medical terminology and science associated with the assigned drugsand 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 6070%

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 wellbeing 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