Senior Clinical Research Associate

AstraZeneca•Tampa, FL

About The Position

The Senior Clinical Research Associate (Sr. CRA) is locally responsible for delivering assigned studies at allocated sites and participates in local study teams. Working closely with Project Management Clinical Operations (PMCO), the Study Start-Up (SSU) manager, the Clinical Study Assistant (CSA), and other CRAs in Country Operations Management (COM), the Sr. CRA helps ensure study commitments are achieved efficiently and on time. The Sr. CRA is the main contact for study sites and monitors study conduct to ensure appropriate delivery and compliance. The role covers selection, initiation, monitoring, and closure of assigned clinical study sites in accordance with Alexion Procedural Documents, ICH-GCP, applicable local regulations, and each site's study commitments. Depending on demonstrated skills and experience, the Sr. CRA may take on additional responsibilities, such as Lead CRA duties. The position includes remote and onsite site visits and data checks, site performance and enrollment management, investigator and site staff support, monitoring documentation, essential document and eTMF oversight, and collaboration on study start-up and regulatory maintenance where required. The Sr. CRA also supports quality issue escalation, audits, and regulatory inspections. Travel may be as high as 70% during busy periods.

Requirements

At least 4 years of CRA monitoring experience.
Bachelor's degree in a related discipline, preferably life science, or equivalent qualification.
Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP.
Excellent knowledge of relevant local regulations.
Good medical knowledge and ability to learn relevant Alexion 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 detail.
Excellent written and verbal communication skills.
Excellent collaboration and interpersonal skills.
Good negotiation skills.
Flexibility in schedule and willingness to travel; required travel may be as high as 70% during busy periods.
Valid driving license.

Nice To Haves

Ability to work with remote collaborators and in a matrix reporting structure.
Ability to manage change positively and view it as an opportunity to improve performance and add business value.
Ability to identify and champion more efficient and effective ways to deliver quality clinical trials with reduced budgets and timelines.
Ability to prioritize and manage multiple tasks with conflicting deadlines.
Proactive and assertive communication with internal stakeholders and sites.
Ability to understand the impact of technology on projects and develop computer skills while using systems and software appropriately in an e-enabled environment.
Team-oriented and flexible, with the ability to respond quickly to shifting demands and opportunities.
Experience across all study phases and in rare medical conditions.

Responsibilities

Perform site selection, initiation, interim monitoring, and closeout visits, remotely and onsite, as well as remote data checks, according to the study-specific Clinical Monitoring Plan timelines.
Drive site performance, proactively identify and resolve study-related issues, and escalate issues as appropriate.
Train, support, and advise investigators and site staff on study matters, including Risk Based Quality Management (RBQM) principles.
Develop recruitment plans with sites, manage and support enrollment, and document recruitment barriers and mitigation plans.
Monitor agreed quality KPIs, including action-item aging, SDV metrics, data-entry metrics, query aging, and monitoring-visit report metrics.
Prepare and finalize monitoring visit reports in CTMS and provide timely feedback and follow-up letters to Principal Investigators in accordance with required timelines and Alexion SOPs.
Ensure timely collection and upload of essential documents to the eTMF and support or participate in regular eTMF QC checks.
Where required, support study start-up and regulatory maintenance, including preparing, reviewing, tracking, and submitting documents to EC/IRB and Regulatory Authorities.
Contribute to nomination and selection of potential investigators and assist with feasibility activities.
Collaborate with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders as needed.
Escalate systematic or serious quality issues, data privacy breaches, and ICH-GCP compliance issues to the appropriate functions as required.
Prepare for and collaborate on audits and regulatory inspections with PMCO, the Director COM, and the Quality Group.