Clinical Research Associate

hace 7 meses

Barcelona, España TFS HealthScience A tiempo completo

Overview:
TFS HealthScience is excited to be expanding our **SRS **team and we are looking for an experienced, highly motivated regional **Clinical Research Associate (CRA)** who shares our vision of providing clinical research excellence. Our **SRS** 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 Clinical Research Associate (CRA) in Barcelona or Madrid.

This role will sit embedded within one of our prestigious clients who promotes rapid career development.

**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.

**Country benefits include**:
Health Insurance

Lunch allowance

Home allowance

Possibility to compensate overtime

Flexibility

Summer working hours

**Responsibilities**:
The Clinical Research Associate (CRA) is part of 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.
- In cooperation with study team, responsible for SMF maintenance
- Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
- Order, ship and coordination of study supplies at site
- May prepare and submit status reports as directed by Lead CRA/PM
- Review and support site staff to maintain SMF
- Review Informed Consent documents for essential elements and protocol specifics
- Update CTMS system with site and study information
- May audit data in tables and text of clinical summaries
- May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness
- Prepare check requisitions for sponsor Project Manager approval, when applicable

Qualifications:

- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Minimum 1 year of experience working as a CRA involved in phase I-II studies, visiting hospital pharmacy
- Used to working by metrics
- 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 written and verbal communication skills.
- Excellent organizational skills
- Ability and willingness to travel
- 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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