Clinical Research Associate

The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s). Working closely with other CRAs and the Local Study Team/Local Study Associate Director (LSAD), the CRA ensures that study commitments are achieved in a timely and efficient manner. Acting as the main contact with the study site, the CRA is responsible for monitoring the study conduct to ensure proper delivery. This role involves preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. A CRA with longer tenure and experience may take on additional responsibilities that include tasks associated with LSAD.

Accountabilities

- Contributes to the selection of potential investigators.
- Accountable for study start-up and regulatory maintenance in some countries.
- Trains, supports, and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles.
- Confirms that site staff have completed and documented the required trainings appropriately.
- Actively participates in Local Study Team (LST) meetings.
- Contributes to National Investigators meetings, as applicable.
- Initiates, monitors, and closes study sites in compliance with AZ Procedural Documents.
- Drives performance at the sites and ensures timely resolution to study-related issues.
- Updates CTMS and other systems with data from study sites as per required timelines.
- Manages study supplies, drug supplies, and drug accountability at study sites.
- Performs monitoring visits (remote and onsite) and remote data checks according to the Monitoring Plan.
- Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV).
- Ensures data query resolution in a timely manner.
- Works with data management to ensure robust quality of collected study data.
- Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups.
- Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator.
- Follows up on outstanding actions with study sites to ensure resolution.
- Follows quality issue processes by escalating systematic or serious quality issues.
- Assists site in maintaining inspection-ready ISF.
- Prepares for and collaborates with activities associated with audits and regulatory inspections.
- Ensures timely collection/uploading of essential documents into the eTMF.
- Provides feedback on any research-related information useful for the local market.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies, and procedures.
- Ensures compliance with local, national, and regional legislation.
- Collaborates with local MSLs as directed by LSAD or line manager.

Essential Skills/Experience

- Bachelor 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.
- 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 with reduced budget and time.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk-based monitoring approach including remote monitoring.
- Good cultural awareness.
- Ability to understand the impact of technology on projects 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.

At AstraZeneca, we are dedicated to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines that achieve the best results for patients in need and healthcare professionals. Our innovative mindset drives us to think broadly about patients' needs, pushing beyond traditional approaches. We value our influential work in shaping drug development and gaining fast, efficient approvals. Our diverse team is empowered to make quick decisions, operate independently, and influence others. We are committed to finding improvements that impact patients with serious diseases by asking questions, trying new things, and sharing new proposals.

Join us in making a difference – apply today!

The annual base pay for this position ranges from $101,948.00 - 152,922.00. 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

06-Nov-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.