Oncology Regulatory Specialist at Abarca Health

Sioux Falls, South Dakota, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Oncology, Clinical TrialsIndustries

Requirements

1-3 years regulatory, quality or data analyst experience (required)
2 years regulatory, quality or data analyst experience (listed as required)
Bachelor's degree (preferred)
1-3 years related research experience and/or training (preferred)
Visual acuity adequate to perform position duties
Ability to communicate effectively with others, hear, understand and distinguish speech and other sounds
Ability to work the specified hours (Day Shift)
Commitment to Avera’s mission, vision, core values, and social principles
Uphold Avera’s standards of Communication, Attitude, Responsiveness, and Engagement (CARE)
Maintain confidentiality
Work effectively in a team environment
Comply with safety principles, laws, regulations, and standards (e.g., CMS, The Joint Commission, DHHS, OSHA)

Responsibilities

Prepares and completes regulatory documents for protocols as requested by investigators, sub-investigators, and clinical research coordinators
Submits all required research documents to the protocol sponsor, Institutional Review Boards (IRB), FDA, and other regulatory agencies as required by the research project
Prepares correspondence, informed consent, and regulatory specific documents for submission for study start-up to sponsors, contract research organizations, and IRBs as required by contracts, statutes, or regulations
Provides regulatory tasks across the Avera Network
Distributes and tracks training and delegated tasks required by the study to ensure compliance
Critically reviews and updates study-related documents to align with the protocol and site requirements
Maintains or manages the electronic regulatory system and maintains regulatory documents on all clinical research studies
Designs and maintains databases, spreadsheets, and other computer files used in the administration of research
Actively assists in developing, coordinating, and participates in research-specific meetings
Submits all ongoing clinical research studies to the appropriate IRB for annual re-approval
Submits all adverse events and safety reports related to clinical research studies to the appropriate IRB
Ensures all ongoing clinical research study regulatory binders have up-to-date professional licenses or certificates

Skills

IRB Submissions

FDA Reporting

Regulatory Documents

Informed Consent

Adverse Event Reporting

Protocol Management

Clinical Research Compliance

Electronic Regulatory Binder

Excel

Databases

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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