Abarca Health

Senior Clinical Research Associate

Munich, Bavaria, Germany

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Clinical ResearchIndustries

Position Overview

  • Location Type: Germany (Onsite)
  • Employment Type: Part time
  • Job Type: Sr CRA (Clinical Research Associate)
  • Salary: Not provided
  • Brief Description: The Sr CRA is a key member of the Alira Health Clinical team, responsible for conducting site monitoring responsibilities for clinical trials. They provide oversight, leadership, and guidance to ensure compliance and quality, working closely with various teams to support study execution.

Requirements

The job description does not list specific requirements.

Responsibilities

  • Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
  • Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
  • Ensures appropriate and timely investigator site visits.
  • Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
  • Assists in development of study-specific Monitoring Plans and training presentations as required.
  • Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
  • Provides monthly billing information to finance team as required.
  • For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
  • Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
  • Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
  • Ensures integrity of CRF data through meticulous and thorough source document review and verification.
  • Performs quality control and verification of documents collected at sites for eTMF/TMF.
  • Conducts investigational product accountability.
  • Reviews site regulatory binder for required documents.
  • Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
  • Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
  • Participates in internal, client/sponsor, scientific, and other meetings as required.
  • Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
  • Works closely with in-house teams.

Company Information

  • Company: Alira Health
  • Team Culture: Collaborative, encourages innovation, values open communication, and promotes a supportive environment. Emphasis on shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Skills

Site Monitoring
Clinical Trial Oversight
Regulatory Compliance
Study Coordination
Documentation and Reporting
Investigator Site Management
Source Data Verification
eTMF/TMF Management

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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