Clinical Research Associate - CRA/ SR.CRA
TFS HealthScience - Contract Research Organization
Barcelona, Catalonia, Spain
hace 4 días
source : Appcast

Responsibilities :

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.

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

Requirements

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

1-5 years' experience working as a CRA independently

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 guidelin

Benefits

25 (+2) working days per year of service

Flexible working times

TFS Academy training courses

Free Private Health Insurance

Flexible remuneration scheme including Nursery ticket and Training

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