Senior Clinical Research Associate

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Name of Employer: Parexel International LLC

Position Title: Sr. Clinical Research Associate

*Multiple Openings Available*

Position Location: 541 Church at North Hills St. Suite 1000 Raleigh NC 27609

*100% Remote reporting to Raleigh NC.

Hours: Full Time / 40 hours per week

Summary of Duties: Engaged in monitoring clinical research that involves understanding human diseases and improving human health. Monitor and oversee clinical trials at client sites. Evaluate quality and integrity of reported data. Represent the company at assigned clinical trial sites and be accountable for quality and delivery from site identification to the close of trial. Conduct drive and manage country-specific feasibility and site pre-qualification and qualification activities which include preparation negotiation and facilitation of execution of Confidentiality Agreements (CDA) Clinical Site Agreements (CSAs) and any amendments. Conduct on-site and remote visits/contacts including Qualification Initiation Monitoring Termination Visits and Site Motivational Visits and generate site visit reports. Develop strategy to configure distribute and 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 customize and negotiate any amendments. Prepare and submit IRB/IEC and MoH/RA applications resolve conflicts and determine appropriate follow-up until receipt of final approval. Address and resolve issues at clinical trial sites including the need for additional training potential deficiencies in documentation and communication. Follow-up on Case Report Form data entry query status and Serious Adverse Events. Assess and manage test article/study supply including supply accountability and destruction/return status. Review and follow-up on site payment status and ensure site receives payments on a timely manner. Communicate study issues that require immediate action with a proposed strategy for resolution. 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. Perform report review of 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.

Education requirements: Bachelors degree or equivalent in biological science pharmaceutical sciences chemistry biotechnology biomedical engineering or a health-related field of study.

Experience requirements: 3 years of experience in clinical research.

Or alternatively:

Education requirements: Masters degree or equivalent in biological science pharmaceutical sciences chemistry biotechnology biomedical engineering or a health-related field of study.

Experience requirements: 1 year of experience in clinical research.

Special Skills or Other Requirements: Applicants must have demonstrated experience with:

Serving as a Lead Clinical Research Associate (CRA) for clinical studies; Clinical Trial Management System (CTMS) and Electronic Document Management System (EDMS); Site Management and application of clinical trial methodology and terminology; Independently monitoring visits (Qualification Site Initiation and Monitoring); Working with clinical research phases of clinical trials current GCP/ICH and country clinical research law and guidelines; and Communicating results to stakeholders in non-technical language.

Travel requirements: Up to 75% Domestic Travel.

*Position eligible for Employee Referral Program*

To apply: Individuals interested in applying for the position may email a resume with Job #ES2401 to

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status which in the US includes race color religion sex sexual orientation gender identity national origin disability or protected veteran status.