KPS is looking for Oversight Monitor to join sponsor team. Small FTE approx 0.2 for this year.
Responsibilities
* contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.
* contributes to the definition of appropriate standards and quality indicators for site management and monitoring.
* ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
* addresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution.
* May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed.
* reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.
* may assist with translations or verification of translations.
* implements approved communication plans with external strategic partners or CROs.
* supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.
* reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan.
* utilizes available tools/systems to assess vendor and site performance.
* ensures inspection readiness at the study sites and follow up corrective/preventive actions.
* maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs).
* provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable)
Qualifications
* computer literacy in appropriate software(s).
* the ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills.
* demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.
* demonstrated management of all clinical study aspects (developing a protocol to clinical study report).
* the ability to identify, solve and escalate issues that arise at study sites and within site management.
* comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.
* demonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills.
* demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
* a degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.
* other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
* a minimum of 8+ years’ relevant clinical research (or related) experience.
* 6+ years’ experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).
* a thorough understanding of the drug development and clinical trial process.
* the ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.
* the ability to participate in preparation, conduct and follow up of audits and site inspections.
* active management experience of countries and sites in a region.
* thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
Benefits
Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.
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