Description
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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
Job Description
THE CLINICAL TRIAL COORDINATOR I ROLE
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 Originally posted on Himalayas
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