Monitor de pesquisa clínica II – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista

Responsibilities include, but are not limited to

• The role is accountable for performance and compliance for assigned protocols and sites in a country;
• Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally;
• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites;
• Actively develops and expands the territory for clinical research, finding and developing new sites;
• Participates in internal meetings and workstreams as SME for monitoring processes and systems;
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial;
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws;
• Regulations, Protocol, Site Monitoring Plan and associated documents;
• Gains an in-depth understanding of the study protocol and related procedures;
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready;
• Participates & provides inputs on site selection and validation activities;
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased;
• Subjects’ right, safety and well-being are protected;
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner;
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out;
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed;
• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites;
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines;
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required;
• Supports and/or leads audit/inspection activities as needed;
• Performs co-monitoring visits where appropriate;
• Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Requeriments

• B.A./B.S. required with strong emphasis in life sciences, science in general and/or biology.
• Must be fluent in Portuguese and have advanced proficiency in English.
• Required previous experience in clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
• Required direct site management (monitoring) experience in a bio/pharma/CRO.
• CORE Competency Expectations:
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines;
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
• Hands on knowledge of Good Documentation Practices;
• Proven Skills in Site Management including management of site performance and patient recruitment;
• Demonstrated high level of monitoring skill with independent professional judgment;
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices;
• Ability to understand and analyse data/metrics and act appropriately;
• Capable of managing complex issues, works in a solution-oriented manner;
• Performs root cause analysis and implements preventative and corrective action.

Behavioural Competency Expectations

• Effective time management, organizational and interpersonal skills, conflict
  management
• Able to work with other experienced research professions to develop skills acrossmultiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Positive mindset, growth mindset, capable of working independently and being selfdriven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.