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Senior Clinical Research Associate

Apply remote type Remote locations Munich-Remote time type Part time posted on Posted 5 Days Ago job requisition id JR

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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. All contributions and new ideas are explored with an open mind, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

Job Description Summary

Job Description

Role

The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials, providing oversight, leadership, and guidance to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Key Responsibilities

Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed.
Ensure appropriate and timely investigator site visits.
Coordinate with cross-functional departments to facilitate negotiation/issue resolution related to clinical trial monitoring.
Assist in developing study-specific Monitoring Plans and training presentations.
Assist in setup/collection of site-specific ethics documents and site contract negotiations.
Provide monthly billing information to the finance team.
Manage study budget and act as a referent for the sponsor on monitoring stand-alone projects.
Perform qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation.
Prepare accurate and timely monitoring visit reports detailing site issues, resolutions, protocol deviations, study progress, and enrollment.
Ensure integrity of CRF data through thorough source document review and verification.
Perform quality control and verification of documents collected at sites for eTMF/TMF.
Conduct investigational product accountability.
Review site regulatory binders for required documents.
Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual, and respond to sponsor requests.
Comply with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
Participate in internal, client/sponsor, scientific, and other meetings as required.
Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.
Work closely with in-house CRAs/CTC and data management to resolve data queries.
Identify site issues proactively and develop problem-solving strategies.
Prepare for audits at study sites as needed.
Collaborate with other CRAs to maintain consistency and promote teamwork.
Assist in CRA new hire training and onboarding.
Mentor other CRAs.
Participate in the development and maintenance of the Clinical Trial Management System (CTMS).
Manage and resolve conflicting priorities to meet commitments.
Perform additional duties as assigned.

Desired Qualifications & Experience

US: BS/BA in life sciences or related field; 3 years in pharma/biotech/CRO, including 2 years clinical monitoring and 1 year management experience.
EU: Minimum 2 years clinical monitoring experience in pharma/biotech/CRO, with ability to manage monitoring activities independently.

Technical Competencies & Soft Skills

Focus on quality; careful, thorough, detail-oriented.
Strong organizational skills; effective in fast-paced environments.
Ability to manage priorities, organize time, and solve problems.
Strong analytical, negotiation, leadership, and team skills.
Ability to travel and manage stress.
Professional, trustworthy, disciplined.
Problem-solving skills for unstructured challenges.
US: Fluent in English, both written and verbal.
EU: Fluent in local language and English.
Excellent communication and interpersonal skills.
Proficient with clinical trial management systems and electronic data capture.
Self-starter, collaborative, adaptable.
Knowledge of clinical research, ICH GCP, and local regulations.
Ability to build positive relationships with sponsors, sites, and team members.
US: Authorization to work in the US.
EU (Italy): Certified Monitor per Italian CRO decree or relevant qualifications.

Languages

English

Education

Bachelor of Science (BS) in Biology, Biotechnology, Life Sciences, or Pharmacy

Contract Type

Contingency Workforce

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