Clinical Research Associate Ii

2 meses atrás

Sao Paulo, Brasil MSD Tempo inteiro

**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;
- 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 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 commitm

  • Clinical Research Associate

    2 meses atrás

    Sao Paulo, Brasil Medpace, Inc. Tempo inteiro

    Job Summary: The Clinical Research Associate at Medpace is offering the unique opportunity to have an **exciting career** in the research of drug and medical device development. For those with **medical and/or health/life science interest and background** who want to explore the research field, **travel throughout Brazil**, and be part of a team bringing...

  • Clinical Research Associate

    2 semanas atrás

    Sao Paulo, Brasil MSD Tempo inteiro

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Main responsibilities** - The role is accountable...

  • Clinical Research Associate Iii

    Há 1 mês

    Sao Paulo, Brasil MSD Tempo inteiro

    Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. - Performs clinical study site management/monitoring activities in...

  • CRA - Clinical Research Associate (Talent Pipeline)

    3 semanas atrás

    São Paulo, Brasil Novo Nordisk AS Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline! Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional...

  • CRA - Clinical Research Associate (Talent Pipeline)

    1 semana atrás

    São Paulo, Brasil Novo Nordisk AS Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline! Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional...

  • Senior Clinical Research Associate I

    2 meses atrás

    Sao Paulo, Brasil PSI CRO Tempo inteiro

    **Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...

  • Senior Clinical Research Associate I

    2 meses atrás

    Sao Paulo, Brasil PSI CRO Tempo inteiro

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Clinical Research Associate

    Há 1 mês

    Sao Paulo, Brasil Parexel Tempo inteiro

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...

  • Principal Clinical Research Associate

    Há 6 dias

    Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Principal Clinical Research Associate** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or...

  • Principal Clinical Research Associate

    2 semanas atrás

    Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Principal Clinical Research Associate** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or...

  • Clinical Research Associate I

    Há 1 mês

    Sao Paulo, Brasil MSD Tempo inteiro

    Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Main responsibilities**: - With the support of the CRA Manager, acts...

  • Initiation Clinical Research Associate I

    2 meses atrás

    Sao Paulo, Brasil Parexel Tempo inteiro

    Working from home with occasional days in our office location in Sao Paulo, as an Initiation Clinical Research Associate (ICRA) you will be the direct point of contact with assigned sites located throughout South America and accountable for quality and delivery during the start-up phase. Duties will include EC submissions / site activation related...

  • CRA - Clinical Research Associate (Talent Pipeline)

    3 semanas atrás

    São Paulo, Brasil Novo Nordisk Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline! Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional...

  • CRA - Clinical Research Associate (Talent Pipeline)

    1 semana atrás

    São Paulo, Brasil Novo Nordisk Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline! Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional...

  • Oncology Clinical Research Associate

    Há 1 mês

    Sao Paulo, Brasil AstraZeneca Tempo inteiro

    AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’ lives and benefit society. Our portfolio is solid and our pipeline is...

  • Clinical Research Associate II

    2 semanas atrás

    São Paulo, São Paulo, Brasil MSD Tempo inteiro

    Job Description Responsibilities include, but are not limited to: The role is responsible for performance and compliance for assigned protocols and sites in a country; Ensures study conduct compliance with ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements; Acts as primary site contact and manager...

  • Clinical Research Associate II

    4 semanas atrás

    São Paulo, São Paulo, Brasil MSD Tempo inteiro

    Job Description Responsibilities include, but are not limited to: The role is responsible for performance and compliance for assigned protocols and sites in a country; Ensures study conduct compliance with ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements; Acts as primary site contact and manager...

  • CRA - Clinical Research Associate (Talent Pipeline)

    1 semana atrás

    São Paulo, Brasil Novo Nordisk Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline!Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional opportunity for...

  • CRA - Clinical Research Associate (Talent Pipeline)

    3 semanas atrás

    São Paulo, Brasil Novo Nordisk Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline!Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional opportunity for...

  • Clinical Quality Associate I

    2 meses atrás

    Sao Paulo, Brasil Curebase Tempo inteiro

    **About the role**: Curebase is seeking a Clinical Quality Associate I who will thrive in a quickly scaling healthcare technology environment. Quality at Curebase is deeply cross-functional, and you will work with nearly every function at the company to conduct risk-based quality management (RBQM) surveillance of Clinical Operations activities at Curebase....