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  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 escalate immediately when needed  

Must be willing to travel 70%+