Clinical Research Associate, Cell Therapy - Mid Atlantic

AstraZeneca; Williamstown (NJ); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation & holidays

Job summary

AstraZeneca plc is seeking a Clinical Research Associate (CRA) to manage local study sites, monitor trials and ensure compliance with ICH-GCP and company SOPs. The role involves coordinating with Local Study Teams and LSAD, training site staff, and overseeing regulatory documents.

The position is field-based with a preference for candidates in the Mid-Atlantic region, requiring travel nationwide and internationally as needed. A life sciences degree with CRA experience is essential.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• 3+ years of CRA or similar clinical research experience.
• Strong knowledge of local regulations and clinical trial requirements.
• Ability to travel nationally and internationally.

Responsibilities

• Prepare, initiate, monitor and close sites per study plans.
• Ensure site compliance with ICH-GCP and AstraZeneca SOPs.
• Train site staff on study-related matters and RBQM principles.
• Maintain site documentation, ISF, and regulatory submissions.

Skills

Site monitoring

Data management

ICH-GCP

Risk-based monitoring

Education

Bachelor’s degree in Life Sciences

Tools

Clinical systems

Job description

The Clinical Research Associate (CRA) has local responsibility for the delivery of studies atallocatedsites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved ina timelyand efficient manner. The CRA acts as the primary contact with study sites andis responsible formonitoring study conduct to ensure proper delivery of clinical trials.

This is a field-based position with a strong preference for candidates residing within the Mid-Atlantic region, including Maryland, Virginia, Washington D.

The CRA is responsible forthe preparation, initiation, monitoring, and closure of assigned sites in clinical studies in compliance with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations, ensuring that sites deliver according to study commitments.

A CRA with longer tenure and experience may take onadditionalresponsibilities, including tasks associated with the Local Study Associate Director (LSAD) role.

Supports study start-up and regulatory maintenance activities, including Site Qualification Visits (SQVs), collection and review of regulatory documents, and submission activities to EC/IRB and Regulatory Authorities as applicable.

• Trains, supports, andadvisesinvestigators and site staff on study-related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms site staff have completed required training, including ICH-GCP training, prior to and throughout the study duration.Ensures sitesremain inspection ready at all times.
• Activelyparticipatesin Local Study Team (LST) meetings.
• Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents.Sharesupdates on patient recruitment and site performance within the LST.
• Drives site performance by proactivelyidentifying, resolving, and escalating study-related issues asappropriate.
• Manages study supplies, ISF documentation, investigational product accountability, and study drug reconciliation/destruction activities where applicable.
• Performs onsite and remote monitoring visits, including remote data review activities,in accordance withstudy-specific Monitoring Plans.
• Performs Source Data Review (SDR), Source Data Verification (SDV), and CRF review activities.
• Conducts Site Quality Risk Assessments and adjusts monitoring intensity accordingly throughout the study.
• Ensurestimelyresolution of data queries and collaborates with Data Management tomaintainhigh-quality study data.
• Prepares andfinalizesmonitoring visit reports and follow-up letters within required timelines andin accordance withAstraZeneca SOPs.
• Followsup on outstanding site actions to ensuretimelyresolution.
• Escalates significant quality issues, compliance concerns, data privacy breaches, or ICH-GCP deviations to Local Management and/or Quality teams asrequired.
• Assistssites inmaintaininginspection-ready Investigator Site Files (ISF).
• Supports audit and regulatoryinspectionreadiness activities in collaboration with LSAD and Quality teams.
• Ensurestimelycollection and upload of essential documents into the eTMF in compliance with ICH-GCP, AstraZeneca SOPs, and local requirements.
• Provides insightsregardinginvestigators, sites, and competing studies relevant to the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics and company policies related to Safety, Health & Environment (SHE), security, technology, finance,and peoplepractices.
• Ensures compliance with local, national, and regional regulations as applicable.
• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line management.

Bachelor’s degree in Life Sciences or related discipline, or equivalent qualification.

• Minimum3 yearsofCRAorsimilarrelevant clinical researchexperience within the pharmaceutical, biotechnology, or CRO industry.
• Good knowledge of relevant local regulations and clinical trial requirements.
• Strong medical and scientific aptitude with the ability to learn AstraZeneca therapeutic areas.
• Good understanding of Clinical Study Management, including site monitoring, study drug handling, and data management.
• Strong collaboration, interpersonal, and relationship-building skills.
• Ability to travel nationally and internationally asrequired.

Clinical trial or relevant experience in Cell Therapypreferred. Abilityto work effectively in an environment with remote collaborators and cross-functional teams.

• Ability toidentifyand champion process improvements that increase efficiency and quality.
• Familiarity with risk-based monitoring methodologies, including remote monitoring.
• Proficiencywithclinical systems, software platforms, and technology-enabled environments.
• Team-oriented, flexible, and responsive to shifting priorities and business needs.

Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. If hired, employee will be in a “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.

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.