Clinical Research Associate

Clinical Research Associate

Are you ready to make a difference in the world of clinical research? As a Clinical Research Associate (CRA), you'll be at the heart of our local study teams, ensuring the successful delivery of studies at allocated sites. Collaborate closely with fellow CRAs and Local Study Managers to meet study commitments efficiently and on time. You'll be the primary contact for study sites, responsible for monitoring study conduct and ensuring compliance with international guidelines and local regulations. With opportunities for growth and additional responsibilities, this role is perfect for those looking to advance their career in clinical research!

Accountabilities:
- Contribute to the selection of potential investigators.
- Manage study start-up and regulatory maintenance, including document preparation and submission.
- Train and support Investigators and site staff in study-related matters.
- Ensure site staff complete required trainings and maintain inspection readiness.
- Participate actively in Local Study Team meetings and National Investigators meetings.
- Initiate, monitor, and close study sites in compliance with AZ Procedural Documents.
- Drive performance at sites, resolving study-related issues promptly.
- Update CTMS and manage study supplies and drug accountability.
- Perform monitoring visits and data checks according to the Monitoring Plan.
- Conduct Source Data Review, Case Report Form review, and Source Data Verification.
- Ensure timely data query resolution and robust quality of collected study data.
- Report Serious Adverse Events accurately and promptly.
- Prepare monitoring visit reports and follow up on outstanding actions.
- Collaborate on audit and regulatory inspection activities.
- Ensure timely collection/uploading of essential documents into the eTMF.
- Provide feedback on research-related information useful for the local market.
- Ensure compliance with AstraZeneca’s Code of Ethics and relevant legislation.

Essential Skills/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.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
- Excellent attention to details.
- Good written and verbal communication skills.
- Good collaboration and interpersonal skills.
- Good negotiation skills.
- Ability to travel nationally/internationally as required.
- Valid driving license.

Desirable Skills/Experience:
- Ability to work in an environment of remote collaborators.
- Positive approach to managing change for self, team, and business.
- Champion efficient methods/processes for delivering quality clinical trials with reduced budget and time.
- Good analytical and problem-solving skills.
- Ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiarity with risk-based monitoring approach including remote monitoring.
- Good cultural awareness.
- Understanding of technology's impact on projects; adept at using systems/software in an e-enabled environment.
- Team-oriented and flexible; responsive to shifting demands and opportunities.

At AstraZeneca, we are driven by a mission to transform the lives of patients living with cancer. Our pioneering spirit fuels bold moves that redefine cancer treatment, supported by one of the broadest Oncology pipelines in the industry. We thrive on collaboration, drawing on diverse expertise to tackle tough medical challenges. Empowered by courage and curiosity, we embrace innovation to create new possibilities. Join us in shaping the future of medicine through interdisciplinary approaches, novel biomarkers, AI, and cutting-edge trial designs. Together, we aim to eliminate cancer as a cause of death.

Ready to take the next step in your career? Apply now to join our dynamic team!

CRAs might have different internal titles based on the experience level (Associate CRA, CRA, Senior CRA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues.

The annual base pay for this position ranges from $105,735.20 - 158,602.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.