Clinical Research Associate at Abarca Health

Framingham, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Clinical ResearchIndustries

Requirements

BS/BA from an undergraduate program (preferably Biology or Life Sciences) or equivalent experience
2 years of clinical research experience
Ability to travel
Proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and ability to multi-task in a fast-paced environment
Self-starter who thrives in a collaborative, less structured team environment
Ability to problem-solve unstructured or ambiguous challenges
Strong command of English, both written and verbal
Excellent communication and interpersonal skills with customer service orientation
Proficient with MS Office Suite, particularly Word and Excel
Permanent authorization to work in the country of application

Responsibilities

Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits
Prepares accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
Facilitates adverse event reporting and ensures reconciliation of SAE reports with source documentation and CRFs
Ensures integrity of CRF data through source document review and verification
Conducts investigational product accountability
Reviews regulatory binder for required documents
Works closely with in-house CRAs and data management to resolve queries on discrepant data
Proactively identifies site issues and develops problem-solving strategies for sites
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests
Conducts audit preparation at study sites as needed
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere
Manages and resolves conflicting priorities to deliver on commitments
Complies with ICH GCP guidelines, FDA regulations, and company SOPs
Participates in industry and client meetings
Performs additional duties as assigned

Skills

Site Monitoring

Protocol Compliance

GCP

CRF Review

Source Data Verification

Adverse Event Reporting

SAE Reconciliation

Investigational Product Accountability

Query Resolution

Audit Preparation

Regulatory Binder 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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