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Job Description
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 sitemanagement/monitoringactivities in compliance withICH-GCP, SponsorSOPs, Local Laws;
Regulations, Protocol, Site Monitoring Plan andassociated 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 maintenanceand study close-out;
Communicates with Investigators and site staff on issues related to protocolconduct, recruitment,retention, protocol deviations, regulatory documentation, siteaudits/inspections andoverall 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, regulatoryaffairs, 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/mentorand sharing best practices asappropriate/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 tothe identificationof new potential sites and works closely with them to develop strongclinical researchcapabilities.
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 TrialAssistant, Study Coordinator, Regulatory CTC or similar.
Required direct site management (monitoring) experience in a
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 andpatient 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.
ehavioural 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 multipletasks simultaneously in a changing environment, with support from Line Manager.
Works effectively in a matrix multicultural environment. Ability to establish andmaintain 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 consistentwith organizational policies and practices.
Important details:
The candidate should be from São Paulo (Capital) or neighbor cities.
This role expects the finalist to travel (75% of time);
The candidate is expected to travel on day to day basis to complete the requested activities with clients and Clinical Centers.
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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