Match score not available

SCRA Italy

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Italy

Offer summary

Qualifications:

Life science degree, 4 years of clinical monitoring experience, 6 years in pharmaceutical or site-based research, Knowledge of ICH GCP guidelines.

Key responsabilities:

Provide monitoring expertise for Sponsor studies
Perform required monitoring visits and report safety issues

KPS Life Research SME https://kpslife.com/

201 - 500 Employees

See all jobs

Job description

KPS life is looking to recruit Senior CRA to join our team on a permanent basis.

Full time position, remote, Italy.

The primary responsibility of the Senior Clinical Research Associate (Sr. CRA/SCRA) is to provide monitoring expertise to each Sponsor study they are assigned. The Sr CRA will perform all the tasks related to monitoring and ensuring clinical studies are being performed in accordance with the Sponsor protocol and GCP ICH guidelines. The Sr CRA will act as the site’s main source of information and performance manager. The CRA will provide support, training, and study procedure knowledge to the sites and study teams to ensure successful conduct and completion of the sponsor’s study.

The Sr CRA/CRA Will

verify that the investigator(s) and study personnel are conducting the study according to the protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects.
perform all required monitoring visits as per the monitoring plan to include: Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close Out Visit (COV).
ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC.
perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.).
review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).

The Sr CRA/SCRA

will have life science degree
onco-hematology experience is a must
will have at least 4 years of clinical monitoring experience.
will have at least 6 years of experience in the pharmaceutical industry or clinical research site-based experience.
will have knowledge of ICH GCP guidelines.
will have the required therapeutic area experience.
must be able to travel (estimated at 60%-70% per week).
system experience preferred (i.e. CTMS, eDC, eTMF etc.)