Alira Health
Job title:
Senior Clinical Research Associate
Company:
Alira Health
Job description
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 SummaryJob DescriptionROLEThe 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; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials 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 RESPONSABILITIESProvides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.Ensures appropriate and timely investigator site visits.Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.Assists in development of study-specific Monitoring Plans and training presentations as required.Assists in set up/collection of site specific ethics documents and site contract negotiation as required.Provides monthly billing information to finance team as required.For monitoring 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 consistently accurate and timely 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 as required.Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.Proactively identifies site issues and develops problem-solving strategies for sites.Conducts audit preparation at study sites as needed.Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.Participates in internal, client/sponsor, scientific, and other meetings as required.Assists in CRA new hire training and onboarding.Performs CRA mentoring.Collaborates with development and maintenance of Clinical Trial Management System (CTMS).Manages and resolves conflicting priorities to deliver on commitments.Performs additional duties as assigned.DESIRED QUALIFICATION & EXPERIENCEUS: BS/BA from an undergraduate program (life sciences or related discipline preferred)US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year of clinical monitoring experience with 1 year of management experienceEU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activitiesTECHNICAL COMPETENCES & SOFT SKILLSQuality focused; Proven ability to be careful, thorough, and detail-orientedStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environmentAble to manage priorities, organize time and solve problemsStrong analytical, negotiation, meeting management, cross-functional team, and leadership skillsAbility to travelAbility to manage stressProfessional, trustworthy and disciplinedAbility to problem-solve unstructured or ambiguous challengesUS: Strong command of English, both written and verbalEU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performedExcellent communication and interpersonal skills with customer service orientationGood computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data captureSelf-starter who thrives in a collaborative, yet less structured team environmentKnowledge of clinical research, ICH GCP and local regulationsKnowledge of Regulatory and Ethical requirementsAbility to establish and maintain positive relationships with Sponsor, Site and Project Team membersUS: 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 EnglishLanguages EnglishEducation Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type Regular
Expected salary
Location
Barcelona
Job date
Fri, 01 Nov 2024 06:33:41 GMT
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