The Senior Clinical Research Associate (Sr. CRA) is responsible for the delivery of clinical studies at allocated sites and plays a key role in the local study team(s). Collaborating closely with Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA), and other CRAs in Clinical Operations Management (COM), the Sr. CRA ensures that study commitments are met efficiently and on time at the country level. 

Acting as the main contact with the study site, the Sr. CRA monitors study conduct to ensure proper delivery and compliance. This role involves the selection, initiation, monitoring, and closure of assigned sites in clinical studies, adhering to AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. 

A Sr. CRA with demonstrated skills and experience may take on additional responsibilities as needed.

Accountabilities

Performing selection, initiation, interim monitoring, and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Clinical Monitoring Plan (CMP).

Driving performance at the sites and proactively identifying and resolving study-related issues.

Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.

Developing recruitment plans with each site and managing enrollment to ensure milestones are met.

Ensuring agreed monitoring KPIs are observed and remain within acceptable quality ranges.

Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator.

Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements.

In some countries, managing study start-up and regulatory maintenance tasks.

Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.

Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders as needed.

Following quality issue processes by escalating systematic or serious quality issues.

Preparing for and collaborating with activities associated with audits and regulatory inspections.

You will need to have:

Senior experience of monitoring

Bachelor’s degree in a 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 AstraZeneca 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 (required travel may be as high as 70% during busy periods)

Valid driving license (*)- to be deleted if not required in a country.

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

Ability to look for and champion more efficient methods/processes of delivering quality clinical trials

Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines

Proactivity and assertiveness when communicating with internal stakeholders and sites

Ability to understand the impact of technology on projects and develop computer skills appropriately

Team-oriented and flexible; ability to respond quickly to shifting demands

Experience in all study phases and in rare medical conditions preferred

At AstraZeneca, we push the boundaries of science to transform complex biology into transformative medicines for rare diseases. Our commitment to transparency, objectivity, and ethics drives us to innovate continuously. With global reach and potent capabilities, we are shaping the future of rare disease treatment to help people live their best lives.

Ready to make a difference? Apply now!

Date Posted

Closing Date

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.