Senior Clinical Research Associate

About the role

Monitor and oversee clinical trials at client sites, ensuring the quality and integrity of reported data. Represent Parexel at assigned clinical trial sites and be accountable for quality and delivery from site identification to the close of trial.

This is a full-time, 100% remote position reporting to Raleigh, NC, with up to 75% domestic travel required.

Responsibilities

• Conduct, drive, and manage country-specific feasibility and site pre-qualification and qualification activities, including preparation, negotiation, and execution of Confidentiality Agreements (CDA) and Clinical Site Agreements (CSAs).
• Perform on-site and remote visits (Qualification, Initiation, Monitoring, Termination, and Site Motivational Visits) and generate site visit reports.
• Develop strategies to configure, distribute, collect, review, and approve high-quality country-specific and site-specific documents, essential regulatory documents, and updated or amended regulatory documentation.
• Customize, review, and negotiate country/site-specific Informed Consent Forms, translations, and any amendments.
• Prepare and submit IRB/IEC and MoH/RA applications, resolve conflicts, and follow up until receipt of final approval.
• Address and resolve issues at clinical trial sites, including additional training needs, documentation deficiencies, and communication gaps.
• Follow up on Case Report Form data entry, query status, and Serious Adverse Events.
• Assess and manage test article/study supply, including accountability and destruction/return status.
• Review and ensure timely site payments, and communicate study issues requiring immediate action with proposed resolutions.
• Ensure assigned sites are audit-ready and inspection-ready.
• Lead and mentor junior CRAs on process/study requirements, perform assessments, and conduct co-monitoring visits.
• Review visit reports of junior CRAs to ensure compliance with GCP and Protocol Guidelines.
• Guide Administrative Support Team members, review their work, and provide performance feedback to management.

Requirements

Applicants must meet one of the following education and experience combinations:

• Bachelor’s degree or equivalent in biological science, pharmaceutical sciences, chemistry, biotechnology, biomedical engineering, or a health-related field, with 3 years of experience in clinical research.
• Master’s degree or equivalent in the same fields, with 1 year of experience in clinical research.

Skills

• Demonstrated experience as a Lead Clinical Research Associate (CRA) for clinical studies.
• Proficiency with Clinical Trial Management System (CTMS) and Electronic Document Management System (EDMS).
• Experience with site management and application of clinical trial methodology and terminology.
• Ability to independently conduct monitoring visits (Qualification, Site Initiation, and Monitoring).
• Working knowledge of clinical research phases, current GCP/ICH, and country-specific clinical research laws and guidelines.
• Strong communication skills, including the ability to present results to stakeholders in non-technical language.