Senior Clinical Research Associate FSP - Dallas TX, San Francisco CA, or Jacksonville FL

Parexel is seeking Senior Clinical Research Associates in Dallas, TX; San Francisco, CA; or Jacksonville, FL. Phase I clinical trial monitoring experience is required, and oncology or immunology experience is preferred.

Job Summary

The Senior Clinical Research Associate (Sr CRA) is responsible for the monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor, and close clinical sites in compliance with the Code of Federal Regulations (CFR) and International Council for Harmonisation/Good Clinical Practice (ICH/GCP) guidelines. The role may provide operational input to clinical study teams as directed.

Key Accountabilities

• Oversight of monitoring responsibilities.
• Apply Standard Operating Procedures (SOPs), Clinical Monitoring Plan (CMP), protocols, study manuals, and other study materials as applicable.
• Help identify and qualify potential investigators.
• Perform Pre‑Study Site Visits.
• Assist with start‑up activities, including essential document review and collection as requested.
• Perform Site Initiation Visits.
• Provide initial and ongoing training to clinical investigators and site staff regarding the study protocol, procedures, documentation, and regulatory requirements.
• Perform Interim Monitoring Visits, including:
  • Monitor site compliance with study protocol and GCP.
  • Conduct source data review and verify adequacy of clinical data by comparing case report forms to source documents per CMP.
  • Ensure the site enters data according to the Case Report Form (CRF) Completion Guidelines and meets data‑entry and query‑resolution deadlines.
  • Perform drug accountability and ensure adequate drug supply.
  • Review research specimen documentation, storage, and processing; ensure shipments are sent to the central lab as required.
  • Assist the study team in resolving lab queries and other issues.
  • Collaborate with the drug‑safety group to ensure site compliance with serious adverse event reporting requirements.
  • Ensure adequacy of clinical supplies at the site.
• Collect and review site essential documents; ensure regulatory files are complete and accurate.
• Monitor site compliance with Institutional Review Board (IRB) policies/processes and ensure timely reporting, submissions, and approvals.
• Track and report progress of the study, data monitoring, protocol variations, issue resolution, and follow‑up compliance.
• Ensure site staff are appropriately trained and responsibilities are delegated to qualified personnel.
• Perform Close‑Out visits as assigned.
• Prepare and complete visit trip reports, confirmation and follow‑up letters within CMP timelines.
• Track, report, and follow all action items to resolution.
• Maintain the Clinical Trial Management System (CTMS) promptly, utilizing available reports and study tools.
• Work proactively with sites to address issues and action items, escalating to the protocol lead/Principal Investigator (PL/PI) as needed.
• Assist Data Management as required.
• Provide co‑monitoring support to develop additional skills.
• Contribute to the preparation and follow‑up of on‑site sponsored quality audits, as assigned.
• Complete routine administrative tasks in a timely manner.
• Discuss scientific, medical, and therapeutic‑area information.
• Attend staff meetings and trainings as required.
• May contribute to other clinical‑trial‑related activities, such as vendor management, data review, or other study‑related tasks.
• Contribute to department initiatives and the development/revision of study‑specific CMP and CRF Completion Guidelines.
• May serve as a Subject Matter Expert (SME).
• Work collaboratively with investigative sites to develop strong, long‑term relationships.
• Comply with Parexel standards, required training curriculum, and applicable regulatory requirements.
• Complete timesheets, submit expense reports, and update CV as required.

Skills

• Excellent communication and organizational skills.
• Ability to discuss scientific, medical, and therapeutic‑area information with small and large groups of medical professionals.
• Proactive multitasking, prioritization, and problem‑solving across diverse functional activities.
• Flexibility regarding work assignments, learning, and travel (55‑75% travel, varying by study and site).
• Highly responsive, proactive team player exercising independent judgment.
• Proficiency in written and spoken English (required); proficiency in local languages as applicable.

Knowledge and Experience

• 4+ years of CRA monitoring experience in a CRO or pharmaceutical organization (required).
• Prior oncology or immunology experience (preferred).
• Experience on global clinical trials (preferred).
• Familiarity with Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and CTMS systems.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, SharePoint).
• FDA/European Medicines Agency (EMEA) inspection readiness (preferred).

Education

• Bachelor of Arts/Science (BA/BS) or equivalent, with at least six (6) years of pharmaceutical/biotech experience, or relevant experience and training.
• Registered Nurse (RN) or other health‑care professional preferred.