Senior Clinical Research Associate
6 meses atrás
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.**
TFS HealthScience is looking for a **Senior Clinical Research Associate** **(Senior CRA) - part-time 0.4 FTE**:
- **home based** **in Portugal.**
**Ophthalmology experience is required - ideally in retinal indications such as Diabetic Macular Edema (DME), Age Related Macular Degeneration (AMD), etc.**
**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.
**Portugal** benefits include**:
- Private Health Insurance
- Accident Insurance
- Lunch Allowance
- Homebased Allowance for home-based employees
- Car Allowance for certain roles
- Flexible working schedule - which encourages a balanced work and home life
**Responsibilities**:
The **Senior Clinical Research Associate (Senior CRA)** is part of SRS and COP 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 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 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.
- 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
- Min 3 years of experience as CRA including relevant on-site monitoring experience
- Ophthalmology experience is required - ideally in retinal indications such as Diabetic Macular Edema (DME), Age Related Macular Degeneration (AMD), etc.
- Risk based / remote monitoring - mandatory
- Gene Therapy - would be advantageous
- 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 Portuguese written and verbal communication skills
- Excellent organizational skills
- Ability and willingness to travel up to 60-70%
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _privacy notice_ 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._
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