Clinical Research Associate

hace 1 semana

Barcelona, España TFS HealthScience A tiempo completo

Overview:
TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions Unit and we are looking for an experienced, highly motivated
**Clinical Research Associate (CRA) **who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solutions Unit 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
**Clinical Research Associate (CRA)**
**home or office based in Spain.**

**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.

**Benefits for Spain include**:

- Private Health Insurance
- Global General Liability Insurance
- Global Travel Insurance
- Lunch Allowance
- Homebased Allowance for home-based employees
- Pre-tax scheme for employees who use the nursery ticket system
- Flexible working schedule - which encourages a balanced work and home life

**Responsibilities**:
The Clinical Research Associate (CRA) is part of the Strategic Resourcing Solutions Unit 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 CRA may 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.

Qualifications:

- Bachelor’s Degree, preferably in life science or nursing; or equivalent

Minimum 1-3 years of relevant clinical experience - more than 2 years of experience as a CRA is a plus
- Experience in risk-based monitoring is a plus
- Able to work in a fast paced environment with changing priorities

Understand 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 Spanish 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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