GCP Compliance Oversight Manager, FSP
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, BiotechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, or related field, and have a minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical research role. Strong knowledge of Good Clinical Practice (GCP) guidelines, ICH regulations, and FDA requirements is essential, along with experience in clinical trial monitoring and data management.
Responsibilities
The Clinical Research Associate will conduct site monitoring visits to ensure adherence to clinical trial protocols and GCP guidelines, review monitoring visit reports, provide guidance and oversight to the CRA team, coordinate with cross-functional departments to resolve issues, assist in the development of monitoring plans and training materials, perform qualification, initiation, interim, and close-out visits, prepare accurate monitoring visit reports, ensure integrity of CRF data through source document review, conduct investigational product accountability, and facilitate adverse event reporting.
Skills
Site Monitoring
Clinical Trials
Regulatory Compliance
Study Coordination
Site Training
Budget Management
Documentation Review
Communication
Team Collaboration
Abarca Health
Pharmacy Benefit Management services provider
About Abarca Health
Abarca Health provides Pharmacy Benefit Management (PBM) services, focusing on flexible and user-friendly solutions for health plans, employers, and government programs like Medicare and Medicaid. Its main product, the Darwin platform, allows clients to quickly implement and modify benefit designs while ensuring compliance with regulations. Abarca Health manages over $5.3 billion in drug spend and processes 100 million prescription claims annually, offering additional services like home delivery for prescriptions. The company's goal is to deliver exceptional service and innovative solutions in the PBM market.
Key Metrics
Aventura, FloridaHeadquarters
2005Year Founded
VENTURE_UNKNOWNCompany Stage
HealthcareIndustries
501-1,000Employees