Senior Clinical Research Associate

🔗Are you being referred to one of our roles by a connection in Alira Health?If so, please apply using the referral link emailed to you.

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

ROLE

TheSr CRA is an importantmember of the Alira HealthClinicalteam. TheSr CRAis highly motivatedand functions independently to conductsite monitoring responsibilities for clinical trials; as well as providingoversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.The Sr CRA works closelywith 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, andassist with study recruitment, site training, and other site-related issues. 

KEY RESPONSABILITIES

• Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.

• Reviewsmonitoring visit reports, conducts co-monitoringand evaluationvisits as needed.

• Ensuresappropriate andtimely investigator site visits.

• Coordinates withappropriate cross-functional departments tofacilitate negotiation/issue resolution for clinical trial monitoring related issues.

• Assists in development of study-specific Monitoring Plans and training presentations asrequired.

• Assists in set up/collection ofsite specific ethics documents and site contract negotiation asrequired.

• Provides monthly billing information to finance team asrequired.

• Formonitoring stand-alone projects, manages study budget and acts as referent for the sponsor.

• Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.

• Prepares consistentlyaccurate andtimely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.

• Ensures integrity of CRF data through meticulous and thorough source document review and verification.

• Performs quality control and verification of documents collected at sites for eTMF/TMF.

• Conducts investigational product accountability.

• Reviews site regulatory binder for required documents.

• Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.

• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.

• Participates in internal, client/sponsor, scientific, and other meetings asrequired.

• Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.

• Works closelywith in-house CRAs/CTC and data management to resolve queries on discrepant data.

• Proactivelyidentifies site issues and develops problem-solving strategies for sites.

• Conducts audit preparation at study sites as needed.

• Works with other CRAs tomaintain consistency and promote a collaborative team atmosphere.

• Participates in internal, client/sponsor, scientific, and other meetings asrequired.

• Assists in CRA new hire training and onboarding.

• PerformsCRAmentoring.

• Collaborates with development and maintenance of Clinical Trial Management System (CTMS).

• Manages and resolves conflicting priorities to deliver oncommitments.

• Performsadditional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

• US:BS/BA from anundergraduate program(life sciences or related discipline preferred)

• US:3years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year of clinical monitoring experiencewith1 year of management experience

• EU:Minimum 2 yearsof clinical monitoring experiencein the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities 

TECHNICAL COMPETENCES & SOFT SKILLS 

• Quality focused;Proven 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, organize time and solve problems 

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills 

• Ability to travel 

• Ability to manage stress 

• Professional,trustworthy anddisciplined 

• Ability to problem-solve unstructured or ambiguous challenges 

• US:Strong command of English, both written and verbal 

• EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed

• Excellent communication and interpersonal skills withcustomer service orientation 

• Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture

• Self-starter who thrives inacollaborative, yet less structured team environment 

• Knowledge of clinical research, ICHGCP and local regulations 

• Knowledge of Regulatory and Ethical requirements 

• Ability toestablish and maintain positiverelationships withSponsor, Site and Project Team members 

• US:Permanent authorization to work in the U.S. 

• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011. 

• EU: Graduation in a scientific health field. 

• EU: Adequate English 

Languages

Education

Contract Type

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.