Senior Clinical Research Associate

AstraZeneca; Cotia; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading global biopharmaceutical company seeks a Senior Clinical Research Associate to oversee clinical trials' monitoring and compliance. The role demands excellence in data management, collaboration with stakeholders, and a commitment to regulatory adherence. This position promises an opportunity to contribute meaningfully to innovative healthcare solutions while advancing professional growth.

Qualificações

• Minimum CRA monitoring experience required.
• Excellent knowledge of ICH-GCP and local regulations.
• Good medical knowledge related to the applicable therapeutic areas.

Responsabilidades

• Ensure monitoring KPIs are observed within quality ranges.
• Prepare and finalize monitoring visit reports.
• Participate in regulatory maintenance and study start-up.

Conhecimentos

Attention to detail

Communication skills

Collaboration

Negotiation skills

Flexibility

Formação académica

Bachelor's degree in life science or equivalent

Descrição da oferta de emprego

Senior Clinical Research Associate

Are you ready to make a significant impact in the world of clinical research? As a Senior Clinical Research Associate, you'll play a pivotal role in ensuring the highest standards of monitoring and compliance are met. Your expertise will drive the success of our clinical trials, contributing to groundbreaking advancements in healthcare. Join us in a dynamic environment where your skills and dedication will be valued and rewarded!

Accountabilities:
- Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
- Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to the Principal Investigator, including follow-up letters, within required timelines and in line with AstraZeneca RDU SOPs.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AstraZeneca RDU SOPs, and local requirements. Support/participate in regular QC checks of the eTMF.
- In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review, and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
- Contribute to the nomination and selection of potential investigators and assist with feasibility activities.
- Collaborate with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders, as needed.
- Follow quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO, COML, HCO, and/or Quality Group as required.
- Prepare for and collaborate with the activities associated with audits and regulatory inspections in liaison with PMCO, SML, COLM, and Quality Group.

Essential Skills/Experience:
- Experience of CRA monitoring experience
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Excellent knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas
- Good understanding of the drug development process
- Excellent understanding of Clinical Study Management including monitoring, study drug handling, and data management
- Excellent attention to details
- Excellent written and verbal communication skills
- Excellent collaboration and interpersonal skills
- Good negotiation skills
- Demonstrates flexibility in schedule and willingness to travel

Desirable Skills/Experience:
- Ability to work in an environment of remote collaborators and in a matrix reporting structure
- Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Proactivity and assertivity when communicating with internal stakeholders and sites
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
- Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.
- Experience in all study phases and in rare medical conditions preferred.

At AstraZeneca, we are driven by a passion for innovation that transforms lives. Our commitment to patients is at the heart of everything we do. We foster a culture where diverse ideas thrive, empowering our team members to explore new possibilities. With a rapidly expanding portfolio, we offer an environment where you can grow professionally while making a meaningful impact on underserved patients worldwide. Join us in our mission to redefine healthcare through integrity, inclusiveness, and connection.

Ready to embark on this exciting journey? Apply now to become part of our team!

Date Posted

16-jun.-2025

Closing Date

23-jun.-2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.