In-House Clinical Research Associate - RWE

In-House Clinical Research Associate

Germany - Munich

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 In-House Clinical Research Associate, Real World Evidence (In-house CRA, RWE) will perform remote monitoring and site management of non-interventional clinical studies, ensuring the studies are conducted, recorded, and reported in accordance with the protocol, RWE standard operating procedures (SOPs), and all applicable regulatory requirements. The In-House CRA, RWE may also support site management and monitoring of interventional studies that are conducted under the RWE department management.

Responsibilities

• Conducts remote monitoring visits such as remote qualification/pre-study visits, remote site initiation visits, remote interim/routine monitoring visits, remote closeout visits, and remote for-cause visits under the direction of the Study Project Manager, RWE or if applicable Lead CRA, RWE
• Action Item (AI) resolution post visit and assists with tracking AIs to completion
• In-house review of eCRF (database) to assess data currency
• Identify safety signals in eCRF and perform respective follow-up with sites
• Generating queries and supports sites with resolving data queries/discrepancies
• Feasibility activities such as feasibility questionnaire maintenance, compilation of results, and completion of site selection/non-selection letters in cooperation with the Study Project Manager, RWE
• Track site recruitment efforts and collect/review site screening logs
• Preparing or conducting training and retraining of site staff
• Reviews daily clinical study status and determines tasks
• Possesses full knowledge of the study protocol, site monitoring plan and study manuals in order to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.)
• Communicates and coordinates effectively with internal project staff members and site staff
• Cooperates with Regulatory Manager work on IRB/EC submissions for sites or on submissions to central IRB on behalf of the site
• Manages site activation processes in collaboration with Study Project Manager, RWE and Project Assistant
• Ensures study progress tracking by updating the Clinical Trial Management System and other tools
• Participates in audit preparation activities as needed
• Perform remote review and monitoring of Informed Consent Forms and other source documents
• May review site-specific language in informed consent forms prior to submission to the IRB/EC
• Collects, reviews, maintains, and tracks required site-level essential documents. Review includes assessment of completeness, accuracy, and compliance with regulatory and local requirements

Experience

• Bachelor's degree (scientific discipline preferred) or directly applicable work experience preferred
• Previous CRO experience preferred (as a CTA, in-house CRA, etc.)
• Proficient with MS Office Suite
• Excellent computer and organizational skills
• High attention to detail required
• Ability to work on varying projects and exercise critical thinking
• Self-starter who can work independently and a team player who can work cross functionally with limited oversight
• Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations/ICH guidelines, as required
• Excellent organizational, interpersonal, and communication skills (both oral and written)
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment
• Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision making, time management, and planning activities
• Ability to collaborate with internal and external colleagues and work well in a team-oriented setting
• Fluency in German and English

We offer

• Friendly and professional environment
• Flexible working hours
• Possibility to work partially from home office

CONNECT WITH US!!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC