[Remote] Clinical Research Associate (Contract)

Note: The job is a remote job and is open to candidates in USA. Priovant is committed to developing therapies for autoimmune diseases. The Clinical Research Associate will work closely with investigative study sites to manage site visits and ensure compliance with regulatory guidelines, while maintaining strong collaborative relationships with site staff.

Responsibilities

• Ensure reputed company 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 to appropriately and met each eligibility criteria
• Interact with clinical site staff to resolve issues and address findings
• Ensure accurate and timely reporting of reputed company, 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
• reputed company site recruitment and enrollment metrics to ensure project timelines are on reputed company; assist site with recruitment efforts, as requested
• Assist with review of pending queries and action items then propose resolution plans
• reputed company through IP accountability and reconciliation; reputed company 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
• reputed company inspection readiness activities to ensure each site is reputed company for potential audits/inspections
• Assist in creation of monitoring tools and training material
• Train other CRAs and team members; may conduct reputed company visits to ensure adequacy of CRAs

Skills

• 4-year BA/BS or equivalent degree required, preferably in reputed company 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 reputed company 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, reputed company, 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
• reputed company 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 reputed company needed
• Must be willing to travel up to 70%
• Familiarity with NDA process and FDA/EMA inspection experience is highly desired
• Experience in Phase II - IV clinical trials preferred

Company Overview

• reputed company is a clinical-stage biotechnology company focused on delivering novel therapies. It was founded in undefined, and is headquartered in reputed company, reputed company, USA, with a workforce of 51-200 employees. Its website is https://priovanttx.com/.

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