Clinical Research Associate Iii

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 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 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 and 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 Clinical Research Associate (CRA) Escalation Pathway as appropriate in collaboration with CRA Manager, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed;
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines;
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required;
- Supports and/or leads audit/inspection activities as needed;
- Following the country strategy defined by Clinical Research Director and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities;
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate;
- Could perform Quality control visits if delegated by other roles and trained appropriate;
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
**Main requirements**:
- Bachelor's degree with strong emphasis in science (pharmacy/biology);
- Fluent in Portuguese and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively;
- Direct site management (monitoring) experience in a bio or pharmaceutical company or a Contract Research Organization (CRO);
- Experience with conducting site motivational visit designed to boost site enrollment;
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & guidelines;
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
- Demonstrated ability to mentor/lead. Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate;
- Hands on knowledge of Good Documentation Practices;
- Proven Skills in Site Management including independent management of site performance and patient recruitment;
- Able to work highly independently across multiple protocols, sites and therapy areas;
- Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment;
- Performs root cause analysis and implements preventative and corrective action;
We are a research-driven biopharmaceutical company. 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.
**We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respect

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