Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The part-time Senior Clinical Research Associate will collaborate closely with investigative study sites to complete required site visits (SQV, SIV, IMV, COV) and perform site management activities to ensure project timelines and deliverables are met.
The Senior CRA must build and maintain strong collaborative relationships with investigative sites, as well as leverage strong knowledge of protocol and regulatory guidelines to ensure protection of subject safety, protocol compliance, adequacy of study staff, and validity of study data. The CRA must be well organized, have high attention to detail skills, be able to adapt quickly to changing priorities, and propose well thought out solutions.
Responsibilities:
Ensure 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 Regulations
Confirm every subject was consented appropriately and met each eligibility criteria
Interact with clinical site staff to resolve issues and address findings
Ensure accurate and timely reporting of AEs, SAEs, and PDs, including any follow-up
Complete high-caliber, on-time site visit reports and letters for each completed site visit
Conduct site staff training/retraining
Assist with site visit report reviews
Oversee site recruitment and enrollment metrics to ensure project timelines are on target; assist site with recruitment efforts, as requested
Assist with review of pending queries and action items then propose resolution plans
Perform thorough IP accountability and reconciliation; oversee IP return/destruction process
Complete ongoing review of ISF and TMF reconciliation to ensure completeness, accuracy, and inspection readiness of both files
Assist with clinical quality metrics and PD listing review to identify trends or areas of risk
Assist in review of SOPs, protocols, informed consent forms, study documents, and study plans
Perform inspection readiness activities to ensure each site is prepared for potential audits/inspections
Assist in creation of monitoring tools and training material
Train other CRAs and team members; may conduct oversight visits to ensure adequacy of CRAs
Requirements:
Preference for candidates located near Porto, Portugal
4-year BA/BS or equivalent degree required, preferably in healthcare or scientific discipline
Minimum of 4 years of independent monitoring experience; preference is 6+ years with experience at both CRO and Sponsor
Rare disease or complex study experience
Deep understanding of ICH, GCP, FDA, and other regulatory guidelines
Strong knowledge of drug development and clinical research processes
Familiarity with NDA process and FDA/EMA inspection experience is highly desired
Experience in Phase II - IV clinical trials preferred
Risk Based Monitoring, Targeted SDV, and Remote monitoring experience
Strong 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 technologies
Dependable with track record of collaborating and making an impact in team settings
Able to interact professionally and confidently with Principal Investigators and clinical site staff
Adaptable with strong prioritization skills across multiple projects
Independent with the professional maturity and foresight to escalate immediately when needed
Must be willing to travel up to 70%
Eligible to work in Portugal
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