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EXECUTIVE DIRECTOR - CLINICAL RESEARCH - HIRE

Department:  Management
Status:  Full Time
Shift:  1st

The Executive Director Clinical Research is the key contact with research sponsors, principal investigators as well as regulatory agencies, institutional review boards and is responsible for the development, implementation, coordination, and leadership (administrative/organizational, regulatory, contractual, budgetary, coverage analysis, and financial) for all clinical research trials conducted at Hoag.  Provides leadership for the clinical research enterprise development and operational coordination into resource allocation which aligns with national and institutional benchmarks. Collaborates with physicians and Hoag Institute leaders to develop and maintain productive relationships to achieve optimal research outcomes. Oversee compliance requirements, budgetary as well as day-to-day financial planning, ongoing assessment, and implementation of effective operational processes.  Provides management and oversight for all pre and post-award activities for federally funded research. Partners with accounting, revenue cycle team, general counsel, compliance, foundation, and any other shared services. Represents research for the organization in the community and professional organizations at the local, state, and national level. Assists with the ongoing review of internal processes to streamline or create new or more efficient processes; assists in executing process change and overseeing to completion.  The Executive Director will also be responsible for oversight of the CME program.

 

Leadership

  • As a subject matter expert, provide a clear and compelling direction for a well-defined strategic vision to allow clinical coordinators and administrative employees to fully understand, embrace and inspire them to work toward achieving the aspirational goals of the research.  Facilitates, mentors, delegates appropriately, and empowers her/his team, with mentoring and management intermixed.

Operations

  • Oversee all clinical research operational activities to reflect best practices and industry standards. Ensure that appropriate proposed projects meet the mission and vision of Hoag and HCRE (Hoag Center for Research and Education) stakeholders.

 

Federal Grant Administration

  • Oversee and be responsible for the organization’s pre-and post-award grant administration, including all non-research hospital grants, federal direct and in direct grants, training grants, and larger program project grant applications. Perform high-level analysis of complex grant and project accounting issues and provide oversight and guidance to the organization related to Federal Grant Audit and Compliance Requirements.  Interfacing with compliance, legal, and finance leadership. 

 

Regulatory

  • Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of the clinical trial portfolio.

 

Compliance

  • Ensure research activities conform to federal and state laws. Manages the provision of consultative services provided to core office staff in the coordination, facilitation, and negotiation of contracts, grants, and agreements on behalf of the institution. Advises senior management on the implications of proposed and existing regulations, policies, and practices governing research compliance in institutions of higher education. Establishes and implements short- and long-range goals, objectives, policies, and operating procedures; monitors and evaluates operational effectiveness and effects changes required for improvement.

 

Finance

  • Facilitates the financial management associated with planning, negotiating, setting up, managing, and closing out clinical research studies. Provides financial insights and analysis tailored to the needs of the Clinical Research Leadership group. Planning & Revenue Cycle by enabling and bringing forward key insights and decisions at the enterprise level. Supports the Clinical Leadership with insights on resource allocation and provides tracking for the financial and strategic commitments. In order to do this effectively be a key member and representative of the enterprise finance function and be responsible for the effective flow and appropriate translation of information. Improve cost recovery by expanding on our ability to budget and bill industry-sponsored clinical research for professional fees and hospital service costs.

 

Job Knowledge, Skills, and Competencies:

Change Management

  • Adapts to changes in the environment on a personal and workload basis. Facilitates constructive and positive change in a team, unit, or other workgroups, including in areas of innovation and new processes, technology, and strategy.

Conflict Resolution

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

Decision Making

  • Knows when and what decisions should be made in a fast-paced, rapidly changing environment, and is able to act upon and put those decisions in place.

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 the work area.  Demonstrates competence in technical skills required for the role, as well as ability to learn and master new skills. For clinical positions, 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 the 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 the day-to-day management of functional unit or department.

Oral/Written Communication

  • Ability to speak and write effectively, demonstrates fundamental command of the language, communicates well using all mediums.

Travel

  • Position may require local travel between various Organization locations.

 

Education and Experience

 

Required:

  • Master’s degree in a scientific discipline required.
  • Minimum five years professional management experience in health care research required (preferably in an academic or clinical trials industry setting)
  • Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines required
  • Documented skill and experience in the management of personnel and budgets
  • Experience in research project activity and its interface for usual and customary health care delivery and its payors to ensure compliance with appropriate regulatory/agency requirements/regulations
  • Oversees record retention according to FDA, IRB and, other regulatory agency and sponsor guidelines

 

Preferred:

  • Doctorate Degree
  • Working knowledge of Microsoft Office programs (such as Word, Outlook, and Excel)
  • Quality Assurance audit planning and implementation and report writing

 

Position Reports to: Senior Physician Executive


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

Job Segment: Clinic, Manager, Medical Research, Clinical Research, Healthcare, Management, Research

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