Jore 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 SummaryThe Lead CRA is an important member of the Alira Health Clinical team. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with US: Director of Clinical Monitoring, In-house CRAs, field CRAs, EU: Associate Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.Job DescriptionKEY RESPONSABILITIESProvides guidance, oversight, and feedback to the field CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.Ensures quality of data is in line with clinical standards and that the rights and safety of patients involved in studies are protected.Monitors performance of CRAs on a continuous basis, including reviewing monitoring visit reports and conducting co-monitoring visits as needed.Performs CRA mentoring and oversight of CRA activities including evaluation of quality of work through co-monitoring.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 Clinical Monitoring Plans and training presentations as needed.Assists in resourcing CRAs for planned and ongoing clinical trials.Supports CRA hiring through initial screening, phone, and video interviews of potential new employees.Responsible for CRA new hire training and onboarding.Conducts review of CRA time and expenses, as appropriate.Provides monthly billing information to finance team.Performs qualification, initiation, interim, and close-out visits both onsite and remote, 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.Conducts investigational product accountability.Reviews site regulatory binder for required documents, performing quality assurance of documents collected at sites for uploading to eTMF/TMF.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.Proactively identifies site issues and develops problem-solving strategies.Conducts audit preparation at study sites as needed.Supports study team with set-up, collection of site specific ethics documents and site contract negotiation as required.Participates and attends bid defense meetings as required.Supports improvement and set up of new company processes/procedures related to monitoring activities.Collaborates with development and maintenance of Clinical Trial Management System (CTMS).Promote a collaborative team atmosphere between CRAs.Participates ent/sponsor, scientific, and other meetings as requiredPerforms additional duties as assigned.DESIRED QUALIFICATION & EXPERIENCEUS: BS/BA from an undergraduate program (life sciences or related discipline preferred)US: 4 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 years’ experience in clinical monitoring with 1 year of management experienceEU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.EU: Graduation in a scientific/health fieldEU: Extensive experience local and international studies, multiple therapeutical areas and phases. Experience in clinical project management is not mandatory but is considered as a plusExcellent knowledge of clinical research, ICH GCP, regulatory, ethical and local regulationsCompensation: USD $110,000 - 130,000 commensurate with experienceTECHNICAL COMPETENCES & SOFT SKILLSProven ability to be careful, thorough, detail-oriented and quality focusedStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize timeStrong analytical, negotiation, meeting management, cross-functional team, and leadership skillsAbility to problem-solve unstructured or ambiguous challengesUS: Strong command of English, both written and verbalExcellent communication and interpersonal skills with customer service orientationGood computer skills, with ability to use CTMS systems, clinical trial databases and electronic data captureKnowledge of Pharmacovigilance processesAbility to travelProfessional, trustworthy and disciplinedAble to manage stress and conflictsLeadership attitudeProblem solving skillsSelf-starter who thrives in a collaborative, yet less structured team environmentUS: Permanent authorization to work in the U.S.EU: Adequate EnglishWORKING CONDITIONS/PHYSICAL DEMANDSNormal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.LanguagesEnglishEducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract TypeRegularSalary RangeThe 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.North America: $110,000-$130,000 annually
3 months ago