Senior Clinical Research Associate

100% remote role reporting to Raleigh, NC. Full-time, 40 hours per week.

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 trial close.

Responsibilities

• Conduct, drive, and manage country-specific feasibility and site pre-qualification and qualification activities, including preparation, negotiation, and execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and amendments.
• Perform on-site and remote visits/contacts (Qualification, Initiation, Monitoring, Termination, and Site Motivational Visits) and generate site visit reports.
• Develop strategy 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 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 follow up on site payment status to ensure timely payments.
• Communicate study issues requiring immediate action with proposed resolution strategies.
• Ensure assigned sites are audit-ready and inspection-ready.
• Lead and mentor junior CRAs on process/study requirements and perform assessments and co-monitoring visits.
• Review visit reports of junior CRAs to ensure compliance with GCP and Protocol Guidelines.
• Guide Administrative Support Team members, review work, and provide feedback to the manager regarding performance.

Requirements

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

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.
• Independent monitoring visits (Qualification, Site Initiation, and Monitoring).
• Working knowledge of clinical research, phases of clinical trials, current GCP/ICH, and country clinical research laws and guidelines.
• Ability to communicate results to stakeholders in non-technical language.

Travel

Up to 75% domestic travel required.