Senior Clinical Research Associate

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.