Contract Clinical Research Associate
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. Reporting to the Director, Clinical Quality Management, the 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 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, adapt quickly to changing priorities, and propose reasonable 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 to 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 through 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:
• 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 70%+
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The 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, adapt quickly to changing priorities, and propose reasonable 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 to 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 through 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:
• 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 70%+
Apply tot his job
Apply To this Job