Parexel
Senior Clinical Research Associate - Midwest/Central US - FSP
United States - Remote · Senior
Sponsorship not specified$60k-$80kDetected 7 days ago
GCPAccountingClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipMentoring
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.
Responsibilities
- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
- Support database release as needed
- Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
- Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
- Drive Quality Event (QE) remediation, when applicable
- Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
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).
- Identify and resolve investigator site issues within required timeframes
- Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
Skills
- Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
- Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- Must be fluent in English and in the native language(s) of the country they will work in
- Ability to travel 60-80%
- Valid driver's license and passport required
- Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
- EEO Disclaimer
- Parexel is an equal opportunity employer.
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.
Visa & Work Authorization
- afety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards
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