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RESEARCH COMPLIANCE PROGRAM MANAGER - CORPORATE COMPLIANCE

Department:  Management
Status:  Full Time
Shift:  1st

Primary Duties and Responsibilities

The Program Manager, Research Compliance serves as a leader in the Corporate Compliance Department. Reporting to the Vice President, Chief Compliance Officer, the Program Manager, Research Compliance provides compliance oversight of Hoag’s clinical research program(s), and assists with designing, implementing and maintaining research standards of conduct in accordance with all applicable laws, regulations and best practices.  The Program Manager, Research Compliance is responsible for planning, implementation, oversight and evaluation of Hoag’s research compliance program to ensure all research activities are compliant with internal research policies and applicable federal, state, and local research regulations. Responsible for responding to all research compliance related inquiries including investigations, corrective action plans, monitoring and improvement activities, and using judgment and expert knowledge to escalate issues to the Hoag Vice President, Chief Compliance Officer.  This role is the resource for research compliance and research billing-related inquiries.  The Program Manager, Research Compliance will also participate in and respond to research– related audits.

Oversees the Research Compliance Program interpreting and applying regulatory laws and guidance governing research, including financial and non-financial regulations.

Conducts internal routine and focused study audits of research activities

Collaborates with key leadership, employees, physicians to identify, research, investigate and resolve research-related compliance issues. Oversees and documents external research regulatory investigations and audits and assists as requested. Partners with business units to ensure corrective action resulting from investigations is taken, including disciplinary action as applicable. Tracks and trends research compliance-related allegations, investigations, and outcomes. Instrumental role in the preparation for external inspections, audits and sponsor visits (including but not limited to industry sponsors and NCI). Develops, coordinates, and participates in an educational training program that ensures compliance with pertinent policies and federal and state standards. Augments training and communication for high risk areas, including, but not limited to, research misconduct, conflict of interest, etc.

Proactively identifies areas of research related risk at Hoag in collaboration with the Chief Compliance Officer. Collaborates on matters involving Hoag investigators to ensure compliance with Hoag Conflict of Interest policies and recommends if proposed activity should proceed, as well as any action, including management plans required.

 

 

 

 

Job Knowledge, Skills, and Competencies

Maintains current knowledge of federal and state laws, regulations and policies governing research such as, the Health Insurance Portability and Accountability Act (HIPAA), the Medicare Clinical Trial Policy, the Federal Policy for the Protection of Human Subjects (the Common Rule), the FDA regulations for the conduct of human subject research (Title 21 CFR).

Individual must possess excellent judgment, attention to detail, strong writing and verbal communications skills, and be able to make critical decisions based on data analysis and a strong understanding of the legal and regulatory requirements applicable to clinical research.

Adaptability – Accommodates and adapts to change as environmental, organizational, workload, task, direction and other conditions change in a constructive and positive manner.

Conflict Resolution - Manages conflict, disagreement and discord among and between staff and work units, while recognizing and addressing sensitivities and stakeholder needs.

Diversity – Demonstrates ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives.

Technology & Equipment Skills – Maintains knowledge of technology, tools, equipment and other devices in work area.  Demonstrates competence in technology skills required for the role, as well as ability to learn and master new skills. For clinical position this includes equipment and devices pertinent to treatment, procedures and practice.

Interpersonal Skills - Listens to and understands what others are saying. Establishes effective working relationships with others, contributing to a climate of mutual respect and cooperation. Uses language to the situation. Demonstrates sensitivity and tact, understanding own effect on the motivation, attitudes and actions of others. Makes favorable first impressions.

Job Knowledge – Demonstrates full knowledge and understanding of concepts and procedures needed to be successful in the role, including knowledge of applicable department, organization and external rules and regulations impacting day to day processes. For clinical positions, this includes clinical procedures required by department and unit, as demonstrated by unit-based competency testing.

Operational Management – Effectively manages people, resources, deliverables, budgets, general administration and other components of day-to-day management of functional unit or department.

Oral/Written Communication - Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums.

Travel – Position may require local travel between various Organization locations

 

Education and Experience

Minimum of an Associate Degree required, a Bachelors’ degree preferred.

A minimum of four (4) years of health care compliance experience with a specific focus on clinical research, preferably in a large healthcare system setting or in an academic medical center.

Working knowledge of federal laws, regulations and guidelines governing research including HIPAA and the Common Rule.

 

Certifications Required

Certified in Healthcare Research Compliance (CHRC) or Certified in Healthcare Compliance (CHC) required


Nearest Major Market: Orange County
Nearest Secondary Market: Los Angeles

Job Segment: Compliance, Program Manager, Medical, Clinical Research, Legal, Management, Healthcare, Research

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