[Remote] Senior Clinical Research Associate at Abarca Health

Europe

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Clinical ResearchIndustries

Requirements

BS/BA from an undergraduate program (life sciences or related discipline preferred)
3 years of experience in the pharmaceutical / biotechnology / CRO industry
2 years of clinical monitoring experience

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 CRAs/CTC and data management to resolve queries on discrepant data
Proactively identifies site issues and develops problem-solving strategies for sites
Conducts audit preparation at study sites as needed
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere
Assists in CRA new hire training and onboarding
Performs CRA mentoring
Collaborates with development and maintenance of Clinical Trial Management System (CTMS)
Manages and resolves conflicting priorities to deliver on commitments
Performs additional duties as assigned

Skills

Key technologies and capabilities for this role

Clinical Trial MonitoringSite ManagementProtocol ComplianceSOP AdherenceMonitoring Visit ReportsCo-MonitoringStudy Budget ManagementEthics DocumentsSite Contract NegotiationCRA OversightProject ManagementRecruitment AssistanceSite Training

Questions & Answers

Common questions about this position

What is the employment type for this Senior CRA position?

The position is full-time.

Is remote work allowed for this Senior CRA role?

The role involves performing qualification, initiation, interim, and close-out visits both remotely and onsite.

What are the key responsibilities of a Senior Clinical Research Associate?

Key responsibilities include providing guidance and oversight to the CRA team, conducting site monitoring visits remotely and onsite, ensuring protocol and GCP compliance, reviewing monitoring reports, and managing study budgets for standalone projects.

What is the company culture like at Alira Health?

The company fosters a global team dedicated to innovation and initiative, where collaboration is encouraged across physical walls and time zones, guided by shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

What experience makes a strong candidate for this Senior CRA role?

Strong candidates function independently in site monitoring, provide leadership to CRA teams, ensure compliance with ICH GCP and regulations, and have experience managing clinical trials including site visits, budget oversight, and cross-functional coordination.

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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