Clinical Research Associate I
Há 7 dias
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 as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites;
- 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 International Conference on Harmonisation Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents;
- Gains an indepth understanding of the study protocol and related procedures;
- Participates & provides inputs on site selection and validation activities;
- Performs remote and onsite monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and Subjects' right, safety and wellbeing are protected;
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & nonvisit contact reports appropriately in a timely manner;
- 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, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed;
- Works in partnership with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and Institutional Review Board/Institutional Ethics Committee and Regulatory Authorities in support of assigned sites;
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines;
- Supports audit/inspection activities as needed;
- Performs comonitoring where appropriate
Main requirements:
- Bachelor's degree with strong emphasis in science (pharmacy/biology);
- Fluent in Portuguese and advanced English (verbal and written);
- Clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator ou similar;
- Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & guidelines;
- Hands on knowledge of Good Documentation Practices;
- Developing skills in Site Management including management of site performance and patient recruitment;
- Developing level of monitoring skill and independent professional judgment;
- Ability to perform root cause analysis and implement preventative and corrective action;
- Works effectively in a matrix multicultural environment;
Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.
For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.
You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.
Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
**We are proud to be a company that embraces the value of bri-
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