Clinical Research Associate

2 meses atrás

Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

**Principal Responsibilities**:

- Acts as primary local company contact for assigned sites for specific trials;
- May participate in site feasibility and/or pre-trial site assessment visits;
- Attends/participates in investigator meetings as needed;
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs)and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits;
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas;
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct;
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented;
- Arranges for the appropriate destruction of clinical supplies;
- Ensures site staff complete data entry and resolve queries within expected timelines;
- Ensures accuracy, validity and completeness of data collected at trial sites;
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents;
- Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management;
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times;
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team;
- Attends regularly scheduled team meetings and trainings;
- Complies with relevant training requirements;
- Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities;
- Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA)site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV);
- Prepares trial sites for close out, conduct final close out visit;
- Tracks costs at site level and ensure payments are made, if applicable;
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff;
- May participate in the Health Authority (HA)and IEC/IRB submission and notification processes as required/appropriate;
- Acts as a point of contact in site management practices;
- May contribute to process improvement and training.

**Qualifications**:
**Education and Experience Requirements**:

- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required;
- Specific therapeutic area experience may be required depending on the position;
- Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines;
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight stay away from home;
- Proficient in speaking and writing the country language (Portuguese) and English;
- Good written and oral communication;
- Home based position.

GIFTS

  • 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...

  • 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 5 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...

  • 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...

  • 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...

  • 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....

  • Clinical Research Associate I

    1 semana atrás

    Sao Paulo, Brasil BeiGene Tempo inteiro

    PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION PREFERRED EXPERIENCE: Pharmaceutical/Biotech Industry, Hematology, Oncology Company Overview: BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over...

  • Clinical Research Associate

    Há 2 dias

    São Paulo, Brasil Novo Nordisk Tempo inteiro

    At Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. As part of that commitment, we advise you that we will prioritize candidates...