Clinical Trial Coordination

**The Clinical Trial Coordinator (CTC) **(M/F/d) - supports Clinical Project and Program Managers in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.

Assignments/Tasks:

- Plan, coordinate, and arrange study communications and meetings on and off-site with both internal and external attendees
- Prepare all necessary documents for the evaluation of new proposals and coordinate the decision process of new AR or ISS projects
- Set up, update, maintain and close Trial Master Files. Assure currency and accuracy of required clinical trials documents
- Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are received
- Communicate with investigator sites on collection of regulatory documents
- Create study materials, including newsletters, study updates, etc. under the direction of a Scientist or Clinical Program Manager Source and distribute study supplies
- Interact with Finance departments to support invoice processing
- Interact with the Sales and Customer service department to support and coordinate external needs and internal processes.
- Under guidance of Clinical Operations management, interact with internal stakeholders and external clients to coordinate the accomplishment of business needs

**Qualifications**:
Work Experience: Relevant clinical or basic research experience working at an Investigator Site, Sponsor or Clinical Research Organization

Special Requirements:

- Familiarity of clinical trial operations, ICH, GCP Guidelines
- Good working experience in a team environment across multi-functional areas
- Highly organized, self-motivated, detail-oriented, proactive, and accurate
- Ability to work with urgency and thrive in a high-energy, fast-paced environment
- Demonstrate excellent communication, verbal and written, and interpersonal skills
- Fluent in written and spoken English
- Demonstrate proficiency in MS Office Suite: Word, PowerPoint, Excel, Project

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”