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Priovant Therapeutics · 2 months ago

Clinical Research Associate (Contract)

United States

Contract

Remote

Mid, Senior Level

4+ years exp

Priovant Therapeutics is dedicated to developing therapies for autoimmune diseases. The Clinical Research Associate will work closely with investigative study sites to ensure compliance with protocols and regulatory guidelines while managing site visits and maintaining strong relationships with site staff.

Biotechnology

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

Qualification

ICH guidelinesGCP complianceClinical trial systemsDrug development knowledgeIndependent monitoring experienceRisk based monitoringPrioritization skillsProfessional maturityCollaborative relationshipsAdaptability

Required

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%