Senior Clinical Research Associate

Europe

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, HealthcareIndustries

Requirements

Candidates should possess a Bachelor's degree in life sciences or a related discipline and have 3 years of experience in the pharmaceutical, biotechnology, or CRO industry, with 2 years specifically in clinical monitoring. Experience with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs is necessary.

Responsibilities

The Senior Clinical Research Associate will conduct site monitoring responsibilities for clinical trials, providing oversight and guidance to ensure compliance and quality. Responsibilities include performing qualification, initiation, interim, and close-out visits, preparing monitoring reports, ensuring data integrity through source document review, and maintaining site regulatory binders. The role also involves coordinating with cross-functional teams, assisting in the development of monitoring plans and training, facilitating adverse event reporting, resolving data queries, and mentoring junior CRAs.

Skills

Clinical Trial Monitoring

Site Monitoring

Protocol Compliance

Clinical Trial Management

Clinical Operations

Regulatory Compliance

Data Management

Site Training

Budget Management

SOPs

Ethics Documents

Contract Negotiation

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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