Clinical Monitor - Pageland, SC, United States - Crimson Technologies

Crimson Technologies

Verified Company

Pageland, SC, United States

2 days ago

Posted by:

James Miller

beBee Recruiter

Freelance

Description

RESPONSIBILITIES
Participation in the selection of external testing centers in accordance with regulatory requirements

Independent preparation, execution, and follow-up of monitoring visits at our internal Phase I testing center or selected external clinical testing centers in the DACH region

Ensuring compliance with approved study protocols while adhering to specified guidelines (ICH GCP) and legal regulations

Initiating study centers, conducting trainings, CRF reviews, query resolution, close-out visits, sponsor reporting, escalation of deficiencies, preparation of monitoring reports, and follow-up letters for monitoring visits

Monitoring clinical studies of various indications

Assisting in the creation, implementation, training, and maintenance of SOPs

Assisting in the creation of study-related and regulatory documents (monitoring guidelines, patient information, and consent forms)

QUALIFICATIONS
Successfully completed degree in natural sciences/medicine, completed vocational training in a natural science/medical field, successfully completed comparable training in a medical profession, ideally with additional qualification as a "Clinical Monitor/CRA," or a comparable qualification

At least 2 years of professional experience as a monitor in conducting clinical studies is mandatory

Excellent knowledge of (inter)national legal requirements for clinical studies, including relevant guidelines such as GCP

Willingness to travel (at least 50% of working time)

Independent and structured work style

Proficient in standard computer programs (e.g. MS Office) and study-related systems

Enjoyment of communication, interaction, and cooperation with respective partners