CRA – Cell Therapy (Michigan/Ohio)

AstraZeneca

3d • $112,154 - $168,232 • Remote

About The Position

The Clinical Research Associate (CRA) has local responsibility for delivering studies at allocated sites and participates in local study teams. Working closely with other CRAs and the Local Study Team and Local Study Associate Director (LSAD), the CRA helps ensure study commitments are achieved efficiently and on time. The CRA is the primary contact for study sites and monitors study conduct to support proper study delivery. The role covers preparation, initiation, monitoring, and closure of assigned clinical study sites in compliance with AstraZeneca procedural documents, ICH-GCP, and applicable local regulations.

The CRA contributes to investigator selection and, where required, study start-up and regulatory maintenance. The role involves training and advising investigators and site staff, monitoring site performance and data quality, managing study and drug supplies, resolving study issues, and maintaining accurate study records and documentation. The CRA also supports inspection readiness, audits, regulatory inspections, and essential-document archiving, and collaborates with local colleagues as directed.

Requirements

• Bachelor’s degree in a related discipline, preferably life science, or equivalent qualification.
• At least 3 years of experience as a CRA.
• Excellent knowledge of international ICH-GCP guidelines and basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant AstraZeneca 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 detail.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally and internationally as required.
• Valid driving license.

Responsibilities

• Contribute to the selection of potential investigators.
• Where required, support study start-up and regulatory maintenance, including site qualification visits and collection, preparation, review, tracking, and submission of application documents to ethics committees/institutional review boards and regulatory authorities.
• Train, support, and advise investigators and site staff on study matters, including Risk Based Quality Management principles.
• Confirm that site staff complete and document required training, including ICH-GCP training, and help ensure sites remain inspection ready.
• Participate in Local Study Team meetings and contribute to National Investigators meetings as applicable.
• Initiate, monitor, and close study sites in compliance with AstraZeneca procedural documents; share patient recruitment and site progress information within the Local Study Team.
• Drive site performance, proactively identify and resolve study-related issues, and escalate issues as appropriate.
• Update CTMS and other systems with site data within required timelines.
• Manage study supplies, drug supplies, and drug accountability at study sites; prepare study drug for destruction when applicable.
• Perform remote and onsite monitoring visits and remote data checks according to the study-specific Monitoring Plan; discuss appropriate visit timing and type with the LSAD when needed.
• Perform Source Data Review, Case Report Form review, and Source Data Verification in accordance with the Monitoring Plan.
• Conduct regular Site Quality Risk Assessments and adjust monitoring intensity during the study as appropriate.
• Ensure timely resolution of data queries and work with data management to maintain the quality of collected study data.
• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups.
• Prepare and finalize monitoring visit reports in CTMS and provide timely feedback and follow-up letters to the Principal Investigator in accordance with required timelines and AstraZeneca SOPs.
• Follow up on outstanding actions with study sites to ensure timely resolution.
• Escalate systematic or serious quality issues, data privacy breaches, and CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
• Assist sites in maintaining inspection-ready Investigator Site Files.
• Prepare for and collaborate on audits and regulatory inspections in liaison with the LSAD and CQAD.
• Ensure timely collection and uploading of essential documents into the eTMF in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements; support regular quality-control checks.
• Ensure study documents under the CRA’s responsibility are available and ready for final archiving and completion of the local portion of the eTMF.
• Provide feedback on research-related information, including sites, investigators, and competing studies that may be useful to the local market.
• Comply with AstraZeneca’s Code of Ethics, company policies and procedures, and applicable local, national, and regional legislation.
• Collaborate with local MSLs as directed by the LSAD or line manager.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.
• Retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level