Research Compliance Director

Recruiter
Option Care Health
Location
Deerfield
Salary
116916.80 USD Annual
Posted
02 Aug 2022
Closes
30 Aug 2022
Employer Sector
Technology, ICT & Telecoms
Contract Type
Permanent
Hours
Full Time
Travel
None
Extraordinary Care. Extraordinary Careers.

With the nation s largest home infusion provider, there is no limit to the growth of your career.

Option Care Health, Inc. is the largest independent home and alternate site infusion services provider in the United States. With over 6,000 team members including 2,900 clinicians, we work compassionately to elevate standards of care for patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the infusion care experience for patients, customers and employees.

At Option Care Health we recognize that part of being extraordinary is supporting and building a workforce that is as diverse as the patients and communities we serve.
Join a company that is taking action to develop a culture that is more inclusive, respectful, engaging and rewarding for all team members. We are committed to hiring, developing, and retaining a diverse workforce.

COVID-19 Vaccine Requirements:

As a leading healthcare provider, we have an undeniable responsibility to protect the health and safety of our patients, customers and team members.

Option Care Health requires that all employees be fully vaccinated against the COVID-19 virus. If you are offered and accept a position, your employment will be contingent upon proof of vaccination, or approved medical or religious accommodation. Proof of vaccination will be required during the onboarding process; application for medical or religious accommodations will be required to be submitted within 5 business days of start date. If medical and/or religious accommodation requests are denied, you must take steps to be fully vaccinated, or your employment will be terminated.

Job Description Summary:

Reporting to the SVP, Chief Compliance Officer, leads and manages Option Care health s research compliance initiatives. Responsible for implementation of organizational policies and procedures, monitoring and auditing processes and other aspects of research compliance program in alignment with growing research activity and expanding business models. The Director is responsible for supporting strategic research goals, cultivating a collaborative and comprehensive research compliance infrastructure, and promoting integrity and compliance with applicable federal and state laws and research regulations, professional and ethical standards, and institutional policies and procedures throughout the research enterprise. Director provides guidance and support to team members staffing research engagements, to include all levels of the organization including senior leadership. Maintains current knowledge of pertinent laws and regulatory requirements. Ensures the rights, welfare, and well-being of human subjects involved in research are protected. Disseminates information throughout the organization to ensure the Institution is aware of research integrity and compliance issues. Works collaboratively with other Option Care Health functional areas as needed as well as with external vendors/sponsors. Creates and maintains an environment of transparency and trust. Job Description:

Job Responsibilities (listed in order of importance and/or time spent)
  • Implements annual research compliance plan leveraging Compliance Specialists and other external resources as needed to effectively effectuate initiatives.
  • Develops policies, procedures, guidelines, and programs that promote the responsible conduct of research that is fully compliant with applicable regulations (local policies, laws, federal regulations, etc.), improve the safe and efficient conduct of research, reduce administrative burden, and improve operational efficiency and accelerate protocol review and decision turnaround times.
  • Conduct needs assessments to proactively identify compliance support needs and opportunities, identify potential risk areas, and play a key role in development and execution of strategies to address identified risks and needs, including compliance controls, policies, processes, training, and communications
  • Oversees the protection of research participant data to ensure HIPAA authorization is obtained, criteria for waivers have been met, and/or proper agreements (Business Associate, Data Use, and Material Transfer) have been executed as applicable
  • Creates communications, training materials and educational content to raise awareness or research standards and requirements and support related risk mitigation.
  • Develops and implements controls designed to ensure compliance with company policies and procedures and regulatory standards.
  • Sets priorities for internal reviews, auditing, and sampling site monitoring (of investigative sites and administrative departments) and ensures execution of corrective actions needed.
  • Manages conflict of interest reviews and protocols.
  • Leads and/or participates in project teams reviewing and implementing research activities; ensures processes and procedures are in place to support execution within regulatory standards, company policies, and in alignment with business goals.
  • Leads and manages responses to audits and inquiries from administrative agencies, sponsors and other third parties. At direction of Chief Compliance Officer, prepares responses to regulatory inquiries and allegations of non-compliance. Manages processes in support of required compliance attestation and certifications.
  • Monitors and audits compliance with Service Agreements, Standard Operating Procedures (SOPs), and Statements of Work (SOW) where applicable, including but not limited to study participant referral/research management, performance of contracted services (where applicable), data collection, data reporting and service fee processing and billing of research services.
  • Supports the development and delivery of training and education related to research compliance
  • Serves as an organizational resource and subject matter expert related to research compliance standards including those related to HIPAA and other privacy standards.
  • Manages sensitive investigations of allegations of misconduct or suspected non-compliance. Maintains confidentiality. Maintains files and documents related to the investigative process in alignment with Compliance Department procedures.
  • Other Program related activities as assigned

Supervisory Responsibilities

Does this position have supervisory responsibilities?

(i.e. hiring, recommending/approving promotions and pay increases, scheduling, performance reviews, discipline, etc.)

No - X

Yes

Basic Education and/or Experience Requirements
  • Master s degree; Compliance credentialling through HCCA; ACRP / SOCRA research certification. Minimum seven (7) progressive experience implementing and managing research compliance programs in a healthcare setting. Five (5) years management experience.
Basic Qualifications
  • Highly experienced in program development including implementing and standing-up research compliance program including policies, procedures, training, auditing, and monitoring activities, engagement of external experts, and identification of resources, staffing and budgetary needs.
  • Expert level understanding of research regulations and standards including protection of human research subjects and data privacy.
  • Experience advising clinical and operational leaders on research compliance risk mitigation
  • Excellent organization and project management skills. Attention to detail required.
  • Experience overseeing research billing compliance
  • Demonstrated effective interpersonal skills. Excellent presentation, verbal, and written communication skills.
  • Ability to work with minimal supervision, exercise independent judgment, serve as both a project leader and team member.
  • Highly experienced problem-solving abilities and techniques with execution of effective responsive actions and recommendations.
  • Proficient computer skills that include the ability to effectively use the Microsoft Office Suite, and acceptable
  • data entry skills.
  • Knowledgeable in clinical trial activities to include GCP/ICH guidelines, external data capturing systems, subject enrollment systems, and other forms of identifiable and de-identifiable forms of data sharing.
Physical Demand Requirements
  • Able to sit and work on a computer for extended periods of time.
Travel Requirements: (if required)
  • Willing to travel up to 25% of the time for business purposes (within state and out of state).
Preferred Qualifications & Interests (PQIs)
  • Infusion services related experience
Due to some state pay transparency laws, below is the minimum pay for the position:

Salary to be determined by the applicant's education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.

Minimum pay is $116,916.80+ Benefits:

-401k

-Dental Insurance

-Disability Insurance

-Health Insurance

-Life Insurance

-Paid Time off

-Vision Insurance

Option Care Health subscribes to a policy of equal employment opportunity, making employment available without regard to race, color, religion, national origin, citizenship status according to the Immigration Reform and Control Act of 1986, sex, sexual orientation, gender identity, age, disability, veteran status, or genetic information.