Clinical Research Associate - Madrid, España - EastHORN Clinical Services

EastHORN Clinical Services

Empresa verificada

Madrid, España

hace 1 semana

Publicado por:

Isabel García

beBee Recruiter

Descripción

Job summary:

As an Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions.

You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties.

You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues.

We are searching for an experienced, ambitious and energetic person, able to undertake challenges in the project, push forward development of the project and function well in the project team.

The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.

Main Tasks of the Position:

Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of studyrelated documentation, organization of meetings and other tasks as instructed by supervisor
Responsible for monitoring of clinical sites, maintenance of study files, conduct of prestudy initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues
Assists in Business Development activities
May have supervisory functions in clinical projects
May be required to train, coach and supervise junior staff

Required Qualifications, Experience, Competencies

Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
Excellent organizational and time management skills
Skills to handle multiple priorities and to work with deadlines and under pressure
Excellent written and oral communication skills
Skills to coach and mentor other clinical staff
Fluent in written and verbal English and Spanish, Portuguese will be very beneficial
Computer skill

Benefits: