Parexel ir globāla klīnisko pētījumu organizācija, kas apkalpo biofarmācijas uzņēmumus visā jaunu zāļu izstrādes procesā. Tās darbība aptver I–IV fāzes klīniskos pētījumus, portfeļa un pētījumu pārvaldību, regulatīvo stratēģiju, piekļuvi tirgum un zāļu dzīves cikla plānošanu. Ar vairāk nekā 21 000 profesionāļu Parexel apvieno klīnisko, regulatīvo un terapeitisko jomu zināšanas ar pacientu ieskatiem un inovatīviem pētījumu plāniem. Uzņēmums atbalsta pētniecību tādās jomās kā onkoloģija, neirozinātne un retās slimības, koncentrējoties uz efektīvāku un pacientcentrētāku klīnisko izstrādi.
Clinical Research Associate II / Senior Clinical Research Associate — Remote, Arizona
Oversee investigator sites and monitor clinical trials for Parexel, supporting patient safety, GCP compliance, recruitment, and study quality. The role covers sites across the United States and is listed as remote in Arizona.
Apraksts
- Oversee investigator sites throughout clinical trials, from site management and monitoring to close-out.
- Protect patient safety and maintain study quality in line with applicable laws, GCP, and sponsor standards.
- Manage site relationships and operational work from site activation through database lock.
- Act as the main contact for assigned sites and coordinate with Site Care Partners, study teams, vendors, and site staff.
- Support site development, coaching, training, protocol education, and recruitment.
- Monitor sites on-site and remotely or electronically during initiation, routine follow-up, and closure.
- Track adverse events and serious adverse events, working with the Drug Safety Unit.
- Submit TMF records, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply details, study progress, and metrics.
- Identify and address site issues, and develop corrective and preventive actions.
- Resolve data queries and complete investigator site close-out activities.
- Oversee investigational product receipt, handling, accountability, storage, and destruction.
- Support database release and, when appropriate, carry out unblinded monitoring duties.
- Maintain knowledge of products, protocols, and therapy areas to support patient safety and clinical guidance.
- Lead quality-event remediation and audit CAPA activities when applicable.
Prasības
- Bring extensive knowledge of clinical trial methods, ICH/GCP, FDA rules, and local regulations.
- Have at least two years of relevant experience monitoring clinical research sites.
- Be fluent in English and the native language or languages of the country where you will work.
- Be able to travel 60–80% of the time.
- Hold a valid driver’s license and passport.
- Have a bachelor’s degree in life sciences or an equivalent professional life sciences qualification, such as nursing, pharmacy, or a medical background.
Priekšrocības
- Equal opportunity consideration regardless of legally protected status.
- The role requires substantial travel; no specific travel allowance or compensation is stated.