Senior Clinical Research Associate (US-West) - FSP

Parexel•Washington, DC

About The Position

The Senior Clinical Research Associate I (Sr. CRA) manages assigned investigator sites throughout clinical trials, including site monitoring, site management, and close-out. The role safeguards patient safety and ensures quality study execution in accordance with applicable laws, Good Clinical Practice (GCP), the Study Monitoring Plan, and client standards. The Sr. CRA manages investigator-site relationships and operational delivery, supporting enrollment, database release, site quality and compliance, and engagement and satisfaction among investigators and site staff. The role resolves protocol-related site issues and works closely with the Site Care Partner (SCP) and other study-team members during site set-up, conduct, and close-out. The Sr. CRA is the primary contact for assigned sites during study conduct and performs onsite and remote or electronic monitoring as needed. The role supports site activation and recruitment, provides training and guidance to site personnel, monitors adverse events and serious adverse events, maintains required study documentation and reports, resolves site and data issues, and oversees investigational product handling at sites. The position may also involve unblinded monitoring, mentoring other CRAs, and supporting audits, inspections, and quality-event remediation. The position reports to a Director of Clinical Site Operations or a Director of Site Management and Monitoring. It requires significant travel within the assigned area, with possible international and weekend travel.

Requirements

At least 3 years of relevant clinical research site-monitoring experience.
Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and local country regulations.
Bachelor’s degree in life sciences, or a professional degree in life sciences such as nursing, pharmacy, or a medical background, or equivalent.
Fluency in English and the native language(s) of the country where the employee will work.
Valid driver’s license and passport.
Ability to travel 60–80% within the assigned area; some international and weekend travel may be required.
Knowledge of clinical research and development processes, global and local regulatory requirements, and operational elements such as monitoring, data acquisition and cleaning, and reporting.
Knowledge of disease and technical areas relevant to clinical studies, including the investigational product and its development plan.
Ability to support sponsor regulatory interactions and inspections.
Knowledge of protocol design and feasibility assessment processes.
Understanding of regional and country culture and medical practice and their effects on clinical-trial delivery.
Ability to work in a matrix team, influence and lead through others, and deliver clinical trials successfully.
Ability to evaluate, interpret, and present complex issues and data to support risk management and mitigation.
Effective verbal and written communication skills with internal and external colleagues and associates.

Nice To Haves

Preferably 2 years of oncology monitoring experience.
Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases.
Global clinical-trial experience.

Responsibilities

Ensure clinical trials are conducted in accordance with the Study Monitoring Plan, applicable laws, GCP, client standards, project goals, timelines, and quality requirements.
Manage clinical trial activities at assigned investigator sites from site activation through database lock.
Serve as the primary point of contact for assigned investigator sites during study conduct, partnering with or escalating issues to the Site Care Partner as appropriate.
Facilitate information flow among the study team, vendors, and investigator sites.
Partner with the Site Care Partner to develop sites and coach and train site personnel on protocol compliance and patient protection; provide protocol training and address site questions when required.
Attend investigator meetings when required, support enrollment, address site activation and recruitment issues, and help define and support site-level recruitment initiatives.
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure in accordance with the monitoring plan and applicable procedures.
Monitor site-level adverse events and serious adverse events, collaborate with the Drug Safety Unit, and follow up with investigator sites to resolve required SAE report information.
Submit required reports, documentation, updates, and tracking within required timeframes, including TMF documentation, site reports and follow-up letters, protocol deviations, recruitment, clinical supply management, study progress, and metrics.
Identify and resolve investigator-site issues and agree on corrective and preventive actions with investigators and site personnel.
Resolve data queries within required timelines and plan and conduct investigator-site close-out activities.
Oversee investigational product receipt, handling, accounting, storage conditions, and destruction at investigator sites.
Support database release as needed and, where appropriate, undertake unblinded-monitor responsibilities.
Maintain detailed understanding of the product, protocol, and therapy area and interact with site healthcare professionals to support clinical development goals.
Support the study clinician in patient safety, eligibility, and clinical guidance for investigators.
Drive Quality Event remediation and, when applicable, serve as a contact for audits and drive development and checks of corrective and preventive actions for audit observations.
Partner with the Site Care Partner and Country Study Operations Manager, and collaborate with other study-team members as needed.
May mentor Clinical Research Associates.
Complete required training, timesheets, expense reports, and CV updates, and comply with Parexel processes, ICH-GCP, and other applicable requirements.