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.
Senior Clinical Research Associate, FSP (Ohio, Remote)
Oversee investigator sites and clinical trial monitoring for Parexel’s clinical development programs. Support patient safety, GCP compliance, recruitment, and study quality.
Apraksts
- Oversee management, monitoring, and close-out of assigned clinical trial sites.
- Protect patient safety and maintain study quality in line with applicable laws, GCP, and sponsor standards.
- Manage investigator site relationships and operations from activation through database lock.
- Act as the primary contact for assigned investigator sites.
- Coordinate information across study teams, vendors, and investigator sites.
- Coach and train site personnel, including on study protocols.
- Support enrollment and address site activation and recruitment challenges.
- Conduct onsite and remote or electronic monitoring for site initiation, routine visits, and site closure.
- Monitor adverse events and serious adverse events in coordination with the Drug Safety Unit.
- Submit trial documents, reports, tracking records, and study metrics on schedule.
- Identify and resolve site issues, and develop corrective and preventive actions.
- Resolve data queries and complete investigator site close-out activities.
- Oversee investigational product receipt, handling, storage, accounting, and destruction.
- Support database release and, when appropriate, perform unblinded monitoring duties.
- Keep product, protocol, and therapy-area knowledge current and guide investigators in support of patient safety.
- Lead Quality Event remediation and support CAPA activities for audit observations.
Prasības
- Bring extensive knowledge of clinical trial methods, ICH/GCP, FDA requirements, and local regulations.
- Have at least two years of relevant clinical research site monitoring experience.
- Be fluent in English and the native language or languages of the country of 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 degree, such as nursing, pharmacy, or a medical qualification.
Priekšrocības
- Equal opportunity employer.
- Travel reimbursement or other travel-related compensation is not specified.