Senior Clinical Research Associate
$83,300 - $138,800
Apply now (opens in a new tab)Senior Clinical Research Associate
L5
$83,300 - $138,800
Occupations
Clinical Research CoordinatorsHealth Technologists and Technicians, All OtherHealthcare Practitioners and Technical Workers, All OtherIndustries
Research and Development in the Physical, Engineering, and Life SciencesResearch and Development in BiotechnologyElectromedical and Electrotherapeutic Apparatus Manufacturing- Perform site monitoring and site management responsibilities through all phases of clinical study (e.g. site selection, site initiation, interim monitoring, and closeout)
- Conduct site visits for all phases (site qualification, site initiation, interim monitoring, and closeout)
- Ensure site compliance to clinical study protocol, applicable regulations and guidelines
- Ensure data integrity by verifying data in case report forms against source documents
- Identify and support site in addressing any noncompliance issues.
- Collect and track regulatory documents, maintain trial master file (TMF) documentation and ensure accuracy
- Communicate relevant updates to study core team
- What you need
- RequiredBachelor's level degree or equivalent in science or health care field 2+ years of relevant clinical research experience
- Fundamental knowledge and good understanding of GCPs, clinical study development process, and logistics
- Ability to apply ISO, FDA and related guidelines toward documentation
- PreferredExperience as a Clinical Research Coordinator, Clinical Trial Coordinator or Clinical Research AssociateCCRA Certification
- Demonstrated independence in performing site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities
Level
SeniorL5
Salary
$83,300 - $138,800
Location
Fremont, CA
Occupation
Clinical Research Coordinators
Industry
Research and Development in the Physical, Engineering, and Life Sciences
Posted
2 days ago
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