Junior Clinical Research Associate - Munich, Deutschland - EMMES

EMMES

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Junior Clinical Research Associate

Germany - Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation.

We believe in the power of truth, so much so that we named our company Emmes, which means truth.

Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity.

We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Clinical Research Associate is responsible for monitoring clinical research study sites, either on-site at investigative sites or remotely, to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements.

The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs and applicable regulations. Up to 80% travel to research sites or between corporate locations is required. Travel may include other countries, dependent upon project assignment.

Responsibilities

Ensures clinical study compliance with Good Clinical Practice (GCP), applicable regulations and SOPs
Builds and maintains solid professional relationship with investigators and site
Evaluates, initiates, monitors and closes out clinical study sites visits and prepares reports from these visits for an approval
Ensures appropriate safety reporting as well as tracking and reporting of adverse events
Verifies case report forms against source documentation
Performs investigational product/ medical device accountability and reconciliation
Identifies site needs and siterelated issues, escalates them and/or initiates corrective actions when necessary and responses to siterelated queries and escalates siterelated issues
Assists in preparing sites for audits, reviews audit reports and contributes to resolve audit findings

Experience