Clinical Trial Coordinator I

Alira Health; München; Vor Ort; EUR 30.000 - 50.000; Vollzeit

Zusammenfassung

Alira Health is seeking a Clinical Trial Coordinator I to support project managers, CRAs, and site teams in delivering trials in compliance with ICH GCP and applicable laws.

You will assist with site feasibility, ethics submissions, TMF setup, document handling, and study reporting across local and international sites. Strong English, a scientific background, and MS Office proficiency are essential for success. Permanent authorization to work in Germany is required.

Qualifikationen

• Graduation in scientific/health field or equivalent experience.
• Strong command of English, both written and verbal.
• Proficient with MS Office Suite.
• Quality focused; careful, thorough, and detail-oriented.
• Strong organizational skills and the ability to multi-task in a fast-paced environment.
• Strong analytical skills with ability to solve unstructured challenges.
• Strong communication and interpersonal skills with customer service orientation.
• Permanent authorization to work in applicable country(-ies).
• Previous experience preferred or ability to quickly learn ICH GCP principles and regulatory requirements.

Aufgaben

• Assist PMs, CRAs, and Study Start-up teams with site identification and feasibility.
• Support meetings by scheduling, preparing agendas, and minutes.
• Lead site start-up activities including ethics submissions and regulatory submissions.
• Maintain relationships with ethics committees and regulatory authorities.
• Manage Trial Master File setup, maintenance, and QC.
• Support ISF preparation and distribution to sites.
• Assist with site/vendor invoicing and study site supplies management.
• Support CRAs with follow-up activities and document translation.
• Participate in audits and perform other duties as assigned.

Kenntnisse

English proficiency

MS Office

Organizational skills

Communication skills

Problem solving

Attention to detail

Ausbildung

Bachelor of Science (BS)

Tools

MS Office Suite

Jobbeschreibung

Job Description Summary

Job Description

THE CLINICAL TRIAL COORDINATOR I ROLE

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.

The Clinical Trial Coordinator (CTC) I assists the clinical research team, supporting Project Managers (PMs), Study Start-up team, Clinical Research Associates (CRAs), and clinical sites to ensure studies are conducted in accordance with ICH GCP, applicable laws, SOPs, and the protocol in respect of study budget and timelines.

ESSENTIAL JOB FUNCTIONS

• Responsible (in collaboration with PM, CRAs, and Study Start-up team, as applicable) for site identification and feasibility, including initial site outreach, follow-up, and circulation and collection of feasibility questionnaires and Non-disclosure Agreements (NDAs)
• Supports PM with the management of and participation in internal, client/sponsor, scientific, and other meetings as required, including but not limited to supporting with scheduling meetings and preparing agendas and meeting minutes
• Responsible (under PM oversight and in collaboration with Study Start-up team, as applicable) for site start-up activities, including Ethics Committees and Institutional Review Boards and Regulatory submissions (at site, national, and international level, as applicable) and site contract and budget negotiation
• Maintains relationships with Ethics Committees (ECs) and Competent Authorities (CAs), as applicable
• Responsible for document management including Trial Master File (TMF) setup maintenance and TMF QC (under PM oversight)
• Supports PM with Investigator Site File (ISF) preparation and distribution to sites
• Supports the PM with the management of study site supplies
• Supports collection and review of site Essential Documents, in collaboration with CRAs
• May support regular communication with sites to address questions, ensure protocol/GCP compliance, determine study progress and monitor subject accrual
• Supports PM with study management activities throughout life cycle of study; collaborates in the preparation of weekly/monthly and/or ad hoc project reports, updating CTMS, and maintaining study-specific trackers as needed
• Supports PM with maintenance of study team training materials
• Supports PM with site/vendor invoicing management, as applicable
• Supports CRAs with follow-up activities
• Supports PM with document translation, as applicable
• Participates in audits, as applicable
• Performs additional duties as assigned

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Graduation in scientific/health field or equivalent experience
• Strong command of English, both written and verbal
• Proficient with MS Office Suite
• Quality focused; ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges
• Strong communication and interpersonal skills with customer service orientation
• Professional and trustworthy
• Permanent authorization to work in applicable country(-ies)
• Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements.

Salary Range

Euro 30.000 - 50.000

Languages

English

Education

Bachelor of Science (BS)

Contract Type

Regular

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

EUR 30,000 - 50,000 gross annually