Parexel je globalna organizacija za klinične raziskave, ki biofarmacevtskim podjetjem pomaga pri razvoju novih zdravil. Njeno delo zajema klinične raziskave faz I–IV, upravljanje portfeljev in raziskav, regulativno strategijo, dostop do trga ter načrtovanje življenjskega cikla. Z več kot 21.000 strokovnjaki Parexel združuje klinično, regulativno in terapevtsko znanje z vpogledi v potrebe pacientov ter inovativnimi zasnovami raziskav. Podjetje podpira raziskave na področjih, kot so onkologija, nevroznanost in redke bolezni, s poudarkom na učinkovitejšem kliničnem razvoju, osredotočenem na paciente.
Senior Clinical Research Associate, FSP – California Remote
Monitor clinical trials across California for Parexel’s FSP team, supporting GCP compliance, site performance, and patient recruitment. The role combines site oversight with collaboration across study teams and clinical research sites.
Opis
- Monitor in-house and outsourced clinical sites for compliance with GCP, SOPs, and study protocols.
- Work with study teams on start-up and feasibility, including site identification and assessment.
- Investigate root causes of CRA and site performance issues, then coordinate escalation and resolution with stakeholders.
- Share monitoring expertise and mentor or train less experienced colleagues as needed.
- Build collaborative relationships with site teams, including investigators, study coordinators, pharmacists, and site administrators, and seek their feedback.
- Coordinate site outreach with study teams, including patient recruitment and retention strategies.
- Contribute to and lead cross-functional discussions on monitoring strategy, including risk-based monitoring.
- Apply regional knowledge to adapt study processes and documents where feasible.
- Represent the Monitoring function at investigator meetings as needed.
- Work with study teams and stakeholders to assess sites, identify performance issues, and implement solutions that support project goals and operational efficiency.
- Carry out other assigned tasks.
Zahteve
- Willingness and ability to travel domestically.
- Ability to work independently and collaboratively within a team.
- Proficiency with Microsoft Office 365 applications, such as Word, Excel, PowerPoint, Outlook, and SharePoint.
- Strong written and verbal communication and organizational skills.
- Relevant clinical research experience in biotechnology, pharmaceuticals, a contract research organization, or medical devices.
- Working knowledge of GCP, ICH guidelines, and FDA regulations.
- Oncology experience preferred.
- At least five years of relevant monitoring experience.
- Bachelor’s degree, nursing degree, or advanced degree.
- A degree in life sciences is preferred.