Administrative Project Coordinator (m/w/d)- Munich / Sponsor-dedicated

Fortrea; Deutschland; Hybrid; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

Join a forward-thinking company as an In-House Clinical Research Associate, where you'll play a vital role in executing clinical research projects. This position offers a blend of office and remote work, ensuring data quality and compliance with regulatory standards. You'll engage directly with project teams and investigative sites, monitor site performance, and support submissions to Ethics Committees. With a focus on professional growth, you'll complete specialized training and work collaboratively to enhance clinical operations. If you're passionate about clinical research and eager to make an impact, this role is perfect for you.

Qualifikationen

• 2-3+ years of relevant clinical research experience required.
• Understanding of biology, study monitoring, SOPs, ICH, GCP.

Aufgaben

• Serve as contact for project team and investigative sites.
• Monitor site performance and implement action plans.
• Coordinate study visits and manage shipment of materials.

Kenntnisse

Organizational Skills

Communication Skills

Computer Skills

Ausbildung

Degree in Life Sciences

Relevant Clinical Research Experience

Tools

CTMS

Jobbeschreibung

Job Overview:

The In-House Clinical Research Associate (IHCRA I) is an essential member of a Clinical Project Team responsible for executing a Clinical Research Project. Responsibilities are based on experience and contribution level, involving Clinical Operations activities in office or home settings, with some travel for site visits or meetings. The role includes ensuring data quality and integrity, complying with SOPs, regulatory standards, and guidelines. Candidates will complete the Fortrea Monitoring Excellence Academy (MEA) training program.

Summary of Responsibilities:

1. Serve as contact for project team and investigative sites, conduct and document site contacts, including creating contact reports.
2. Monitor site performance, implement action plans for underperforming sites with CRA support.
3. Assist CRAs with site visit preparations, report QC, and resolve action items.
4. Perform Case Report Form review, generate queries, and resolve them following data review guidelines.
5. Coordinate study visits, manage shipment of study materials and samples.
6. Ensure subject compliance with protocol, visits, and timelines.
7. Distribute and track clinical trial supplies, ensuring adequate inventory at sites.
8. Maintain site documentation, including FDA forms, licenses, CVs, and IRB submissions.
9. Proactively work with sites and teams to complete maintenance activities.
10. Understand and utilize CTMS for study documentation and reporting.
11. Assist in producing status reports with the CTA.
12. Work efficiently within study budgets under supervision.
13. Support submissions to Ethics Committees and Regulatory Authorities.

ON-SITE:

• Assist CRA I, II, Sr. CRA, and other team members with on-site tasks such as form reviews and regulatory file checks.

REMOTE:

• Perform remote visits (phone-based), facilitate document translation, and handle administrative tasks.
• Attend meetings and present as needed, including investigator and sponsor meetings.

Qualifications (Minimum Required):

• Degree in life sciences or related health profession, or relevant clinical research experience (2-3+ years).

Experience (Minimum Required):

• At least one year in a related field, with clinical research experience preferred.
• Understanding of biology, study monitoring, SOPs, ICH, GCP.
• Strong organizational, communication, and computer skills.
• Fluent in local language and English.

Physical Demands/Work Environment:

• Office environment, some travel required.

Learn more about our EEO & Accommodations request here.