Parexel
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - Northeast or Central US - FSP
United States - Remote · Senior
Sponsorship not specified$60k-$80kDetected 22 days ago
GCPData ScienceAccountingRecruitingClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationCollaborationMentoring
About the role
- 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
- provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
- Attend investigator meeting when required (virtual or F2F).
Skills
- Preferred therapeutic experience in Oncology
- Global clinical trial experience preferred
- Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
- Must be fluent in English and in the native language(s) of the country they will work in
- Travel (60-80%) within area is required
- Valid driver's license and passport required
- Knowledge and Experience:
- Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
- Demonstrated knowledge of global and local regulatory requirements
- Demonstrated ability to support sponsor regulatory interactions/inspections
- Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Compensation
- $60k-$80k
Benefits
- At Parexel, we all share the same goal - to improve the world's health.
Company info
- When our values align, there's no limit to what we can achieve.
Equal opportunity
- Parexel is an equal opportunity employer.
Visa & Work Authorization
- nt safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards
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