Clinical Trial Coordinator

Alira Health; Deutschland; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

An innovative firm is seeking a Clinical Trial Coordinator to join their global team. This role is pivotal in assisting the Clinical Research team with start-up activities, ensuring compliance with regulations, and maintaining project timelines and budgets. The ideal candidate will possess a strong background in clinical research and regulatory requirements, along with excellent organizational and communication skills. This position offers an exciting opportunity to contribute to meaningful projects in a collaborative environment where your ideas and contributions are valued.

Qualifikationen

• Graduation in a scientific/health field is required.
• Previous experience in clinical research is essential.

Aufgaben

• Assist in start-up activities and document management for clinical trials.
• Maintain relationships with ethics committees and regulatory authorities.

Kenntnisse

Clinical Research

Regulatory Knowledge

Organizational Skills

Communication Skills

Analytical Skills

Detail-oriented

Ausbildung

Bachelor of Science in Life Sciences

Bachelor of Science in Pharmacy

Tools

MS Office Suite

Jobbeschreibung

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary
As the Clinical Trial Coordinator, you will assist the Clinical Research team and Project Manager in ensuring the study is conducted in accordance with ICH-GCP, SOPs, Study Protocol, and within the timelines and budget.

Job Description
ROLE

The Clinical Trial Coordinator assists the clinical research team to ensure the study is conducted in accordance with GCP, SOP, protocol, and within budget and timelines. The Clinical Trial Coordinator is responsible for start-up activities and document management.

KEY RESPONSIBILITIES

1. Responsible (under PM oversight) for start-up activities, including Ethics and Regulatory submissions (at national and international levels) and site contracts' negotiation.
2. Responsible for ISF preparation and TMF setup and maintenance (under PM oversight).
3. Maintains relationships with ECs and CAs.
4. Supports site/vendor invoicing management and is responsible for maintaining appropriate tracking if required.
5. Collaborates in the preparation of weekly/monthly and ad hoc project reports, updates CTMS, and maintains study-specific trackers as needed.
6. Supports CRAs activities follow-up.
7. Assists with document translation, if required.
8. Participates in internal, client/sponsor, scientific, and other meetings as required; participates in audits.
9. Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

1. Graduation in a scientific/health field.
2. Previous experience in clinical research (in CROs, Pharma, or academia/hospital experience).
3. Good knowledge of ICH GCP and appropriate regulations.
4. Good knowledge of Clinical Research and Regulatory/Ethical requirements.

TECHNICAL COMPETENCES & SOFT SKILLS

1. Good command of English.
2. Proficient in MS Office Suite.
3. Professional and trustworthy.
4. Quality-focused; ability to be careful, thorough, and detail-oriented.
5. Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time.
6. Strong analytical skills.
7. Strong communication and interpersonal skills with a customer service orientation.

Languages
English

Education
Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy

Contract Type
Regular