[Remote] Contract Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Priovant Therapeutics is committed to developing therapies that address high unmet need in autoimmune disease. The Clinical Research Associate will collaborate closely with investigative study sites to complete required site visits and perform site management activities to ensure project timelines and deliverables are met.ResponsibilitiesEnsure all activities associated with each type of site visit are completed in compliance with ICH-GCP, SOPs, Clinical Monitoring Plan (CMP), Protocol, Study Plans, Local Laws and RegulationsConfirm every subject was consented to appropriately and met each eligibility criteriaInteract with clinical site staff to resolve issues and address findingsEnsure accurate and timely reporting of AEs, SAEs, and PDs, including any follow-upComplete high-caliber, on-time site visit reports and letters for each completed site visitConduct site staff training /retrainingAssist with site visit report reviewsOversee site recruitment and enrollment metrics to ensure project timelines are on target; assist site with recruitment efforts, as requestedAssist with review of pending queries and action items then propose resolution plansPerform through IP accountability and reconciliation; oversee IP return/destruction processComplete ongoing review of ISF and TMF reconciliation to ensure completeness, accuracy, and inspection readiness of both filesAssist with clinical quality metrics and PD listing review to identify trends or areas of riskAssist in review of SOPs, protocols, informed consent forms, study documents, and study plansPerform inspection readiness activities to ensure each site is prepared for potential audits/inspectionsAssist in creation of monitoring tools and training materialTrain other CRAs and team members; may conduct oversight visits to ensure adequacy of CRAsSkills4-year BA/BS or equivalent degree required, preferably in healthcare or scientific disciplineMinimum of 4 years of independent monitoring experience; preference is 6+ years with experience at both CRO and SponsorDeep understanding of ICH, GCP, FDA, and other regulatory guidelinesStrong knowledge of drug development and clinical research processesRisk Based Monitoring, Targeted SDV, and Remote monitoring experienceStrong technical experience with clinical trial systems (CTMS, EDC, eTMF, ePRO, eREG eSource, EMR, IRT/IXRS, etc.) with the ability to quickly learn new software and technologiesDependable with track record of collaborating and making an impact in team settingsAble to interact professionally and confidently with Principal Investigators and clinical site staffAdaptable with strong prioritization skills across multiple projectsIndependent with the professional maturity and foresight to escalate immediately when neededMust be willing to travel 70%+Experience in Phase II - IV clinical trials preferredFamiliarity with NDA process and FDA/EMA inspection experience is highly desiredRare disease or complex study experienceCompany OverviewPriovant Therapeutics is a clinical-stage biotechnology company focused on delivering novel therapies. It was founded in undefined, and is headquartered in New York, New York, USA, with a workforce of 51-200 employees. Its website is https://priovanttx.com/.