Clinical Research Associate
ArteraSalary not specified
Full Time
Mid-level (3 to 4 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, HealthcareIndustries
Requirements
Candidates should possess a BS/BA degree in a life sciences or related discipline and have at least 3 years of experience in the pharmaceutical, biotechnology, or CRO industry, with a minimum of 2 years in clinical monitoring. Familiarity with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs is essential.
Responsibilities
The Senior Clinical Research Associate will conduct site monitoring responsibilities for clinical trials, providing oversight and guidance to ensure compliance and quality. This includes performing qualification, initiation, interim, and close-out visits, preparing monitoring reports, verifying data integrity through source document review, and ensuring investigational product accountability. The role also involves maintaining contact with study sites, facilitating adverse event reporting, resolving data discrepancies, and assisting with CRA training and mentoring.
Skills
Clinical Trial Monitoring
Site Monitoring
Protocol Compliance
Study Recruitment
Site Training
Ethics Documents
Contract Negotiation
Budget Management
Leadership
Oversight
Guidance
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.
Aventura, FloridaHeadquarters
2005Year Founded
VENTURE_UNKNOWNCompany Stage
HealthcareIndustries
501-1,000Employees
Benefits
PTO
Parental leave
Work flexibility
Health insurance
Wellness stipend
401k
Tuition reimbursement
Leadership development programs
Risks
Increased competition from Amazon Pharmacy and Mark Cuban's Cost Plus Drug Company.
Growing focus on specialty drugs may require platform adaptation.
Shift towards price transparency could pressure Abarca's pricing models.
Differentiation
Abarca Health's Darwin platform is highly adaptable and user-friendly.
The company offers innovative programs like Triple S en Casa for home delivery.
Abarca Health ensures compliance with ever-changing healthcare regulations.
Upsides
Abarca transitioned two million members to Darwin in 18 months, showing operational efficiency.
Collaboration with Blue Shield of California boosts Abarca's reputation in the PBM sector.
Recognition as a top IT workplace attracts top talent, driving innovation.
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