Clinical Research Associate Ii (São Paulo - Capital)

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.
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. 
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.
Effective time management, organizational and interpersonal skills, conflict 
management
Able to work with other experienced research professions to develop skills across multiple 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.
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. Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 
Employee Status:
Regular 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 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.
B ehavioural Competency Expectations: Effective time management, organizational and interpersonal skills, conflict 
management
Able to work with other experienced research professions to develop skills across multiple 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.
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 Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
No Travel Requirements:
75%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
NoJob Posting End Date:
06/13/2024 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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