Senior Clinical Research Associate

Parexel•Raleigh, NC

2d•Remote

About The Position

At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.

Requirements

Bachelor’s degree or equivalent in biological science, pharmaceutical sciences, chemistry, biotechnology, biomedical engineering, or a health-related field of study and 3 years of experience in clinical research.
Master’s degree or equivalent in biological science, pharmaceutical sciences, chemistry, biotechnology, biomedical engineering, or a health-related field of study and 1 year of experience in clinical research.
Demonstrated experience with serving as a Lead Clinical Research Associate (CRA) for clinical studies
Demonstrated experience with Clinical Trial Management System (CTMS) and Electronic Document Management System (EDMS)
Demonstrated experience with Site Management and application of clinical trial methodology and terminology
Demonstrated experience with independently monitoring visits (Qualification, Site Initiation, and Monitoring)
Demonstrated experience with working with clinical research, phases of clinical trials, current GCP/ICH, and country clinical research law and guidelines
Demonstrated experience with communicating results to stakeholders in non-technical language.

Responsibilities

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.