Contract Clinical Research Associate

Priovant Therapeutics, Inc.; Northern (KY); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Priovant Therapeutics, Inc. is seeking a Clinical Research Associate to collaborate with investigative study sites, perform SQV, SIV, IMV, and COV site visits, and manage activities to meet project timelines.

The CRA will build strong relationships, ensure subject safety and protocol compliance, and maintain data integrity while adapting to changing priorities. Travel is expected at 70%+ with occasional training and mentoring duties.

Qualifications

• BA/BS or equivalent degree required in healthcare or scientific discipline.
• Minimum of 4 years independent monitoring experience; 6+ preferred.
• Experience in rare disease or complex studies is a plus.
• Strong knowledge of ICH, GCP, FDA and related regulations.
• Deep understanding of drug development and clinical research processes.
• Familiarity with NDA process and FDA/EMA inspections desired.
• Experience in Phase II–IV trials and risk-based monitoring.
• Proficient with clinical trial systems and new software.
• Must travel approximately 70%+.

Responsibilities

• Complete site visits (SQV, SIV, IMV, COV) and site management activities.
• Ensure ICH-GCP compliance, protocol adherence and data integrity.
• Interact with site staff to resolve issues and findings.
• Report AEs/SAEs/PDs accurately and timely.
• Prepare high-quality site visit reports and correspondence.
• Conduct staff training and oversee training quality.
• Support site recruitment and enrollment targets.
• Review queries and action plans; propose resolutions.
• Oversee IP accountability, TMF/ISF reconciliation, and inspections readiness.
• Assist with SOP/protocol reviews and monitoring tooling development.

Skills

Independent monitoring

ICH-GCP knowledge

Regulatory guidelines

CTMS/EDC/eTMF familiarity

Travel readiness

Clinical development understanding

Team collaboration

Protocol and data integrity

Education

Bachelor's degree in healthcare or science

Tools

CTMS

EDC

eTMF

ePRO

eSource

EMR

IRT/IXRS

Job description

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 clini cal 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 elevate immediately when needed
• Must be willing to travel 70%+