Overview:
TFS HealthScience is excited to be expanding our
Clinical Operations team and we are looking for an experienced, highly motivated
Senior Clinical Research Associate (Senior CRA) who shares our vision of providing clinical research excellence. Our
Clinical Operations team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes 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 organisation.
Together we make a difference.
This is a permanent position with focus on career progression and dedicated to one of our biggest prestigious pharmaceutical clients.
We look forward to receiving your application!
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.
Our benefits for Hungary include:
- Global General Liability Insurance
- Global Travel Insurance
- Homebased Allowance for home-based employees
- Car Allowance and paid mileage for selected roles
- Flexible working schedule – which encourages a balanced work and home life
Responsibilities:
The Senior Clinical Research Associate (Senior CRA) is part of our CDS delivery team within TFS Develop and 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 (Senior 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 CRA may also conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out).
- 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
- Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
- 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
- Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with 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.
Qualifications:
- Bachelor's Degree, preferably in life science or nursing; or equivalent
- Experience as CRA including relevant on-site monitoring
- 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 English and Czech written and verbal communication skills
- Excellent organizational skills
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for further details.
TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.