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Director Research Office - Sharp HealthCare | Relocation Assistance or Sign-on Bonus Eligible for non-Sharp employees

Job ID JR133353 Date Posted 01/11/2023
San Diego, California
  • Frost Street Building
  • Day
  • Regular
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Responsibilities

Hours


Shift Start Time:

8 AM

Shift End Time:

5 PM

Additional Shift Information:

Weekend Requirements:

No Weekends

On-Call Required:

No

Hourly Pay Range (Minimum - Midpoint - Maximum):

$69.621 - $89.833 - $110.045


The stated pay scale reflects the range that Sharp reasonably expects to pay for this position.  The actual pay rate and pay grade for this position will be dependent on a variety of factors, including an applicant’s years of experience, unique skills and abilities, education, alignment with similar internal candidates, marketplace factors, other requirements for the position, and employer business practices.


What You Will Do


This is a key professional position responsible for developing and overseeing a centralized Research Office (RO) for Sharp HealthCare. This would include oversight of the existing Institutional Review Board (IRB), the Clinical Trials Financial Analyst, the Investigational Pharmacist and the currently approved research. The position is being added to centralize the research functions which today exist across the health system. It also includes working the Foundation grant writer, Sharp HealthCare physicians and employees interested in conducting research. The role has as its key purposes to enable and facilitate research at Sharp HealthCare while providing the infrastructure to ensure the research is conducted in accordance with all governing laws and regulations.

The Director Research Office position requires an in-depth knowledge of the ethical conduct of research, research site practices, federal regulations (including U.S. Food and Drug Administration (FDA), the Department of Health and Human Services' (DHHS) Office for the Protection of Human Research Participants (OHRP), Health Insurance Portability and Accountability Act (HIPAA), state and local laws, Sharp HealthCare policies and procedures, Sharp HealthCare's Human Research Protection (HRP) Program, mitigation and/or elimination of potential conflicts of interest in research, and policies related to Good Clinical Practice (GCP) in the conduct of research.

Required Qualifications

  • Master's degree
  • 5 years of leadership experience, specifically in the conduct of research or completion of coursework in research methodology, design, and statistics.


Essential Functions

Provide oversight:
Act as a liaison with the parties involved in conducting research. This includes, but is not limited to, researchers, clinicians, Sharp HealthCare leaders, the FDA, industry sponsors of research and others to manage research activities and facilitate communications.
Develop a centralized effort to oversee research application processes, budgets, and research billing to ensure compliance with federal regulations.

  • Oversee development of education and training programs for Sharp HealthCare staff and physicians involved in research. These include federal regulations and approved policies and procedures (e.g., financial management, protection of human subjects, the research life cycle, internal and external audits, etc.) to promote ethical conduct in research.
  • Together with Sharp HealthCare legal counsel, negotiate and execute industry sponsored contracts implement conflict of interest policies and role model compliance with them.
  • Provide analysis, interpretation, decision-making processes, reporting, coordination and management for the RO’s administrative and operational structure to include clinical trial contracting, service agreement, and research compliance.
    Development of standard policies and procedures, along with regular reviews and updates.
    Accelerate research start-up process by previewing contracts and protocols.
    Provides information about Sharp HealthCare’s clinical research capabilities.
  • Research Compliance:
    Oversee overall compliance in relevant areas of regulatory affairs.
    Analyze and coordinate research compliance assurance in the areas of potential financial conflicts of interest by means of routine, comprehensive assessment of adherence to established policies and procedures.
    Conduct regular and ad hoc / random audits of clinical research studies to assure that they are being conducted in accordance with the research protocol, the safety monitoring plans, and the consent process requirements as approved by the IRB, in accordance with Good Clinical Practice and/or other regulations.
    Work collaboratively with administration and the clinical trials financial analyst to ensure design and implementation of efficient, effective standard operating procedures and policies relating to the financial management process.
    Act as a resource for information regarding federal and local regulations governing the conduct of research.
    Oversee development and implementation of a system to assess, track and provide corrective actions for clinical trial billing and regulatory risk.
    Assures that the research budget provides payment to Sharp HealthCare for study related expenses
  • Business Development:
    Serve as a consultant to Sharp HealthCare’s IRB.
    Enhance awareness of clinical research throughout Sharp HealthCare.
    Directs the design and implementation of a strategic plan for clinical trial financial management which supports seamless, efficient assistance to researchers; eliminates activities that impede the research mission, and strengthens Sharp HealthCare HealthCare’s capabilities to support research endeavors of merit.
    Facilitate relationships with internal and external clinical trials customers to foster expanded opportunities for collaboration and/or participation in clinical research.
    Development of Sponsor/CRO surveys to evaluate Sharp HealthCare’s performance as a clinical research site in which results are compiled and used to market Sharp HealthCare’s success.
  • Personnel Management and Supervision:
    Responsible for RO cost center.
    Manage FTEs associated with RO including the IRB Administrator, Clinical Trials Financial Analyst, and physician consultants.


Knowledge, Skills, and Abilities

  • Strong knowledge of GCP guidelines, FDA and OHRP regulations.
  • Demonstrated scientific knowledge, as evidenced by advanced degree and/or experience/working knowledge in health care and related scientific fields.
  • Seasoned professional with managerial skills and knowledge of local, state and federal laws regarding the conduct of research.
  • Must have excellent communication and political skills, including persuasiveness, assertiveness, initiative, and sensitivity with all levels of staff.
  • Must be an effective spokesperson for the health system with regard to research.
  • Must be able to work under pressure, remain flexible with conflicting priorities, while sill accomplishing goals through creative implementation of the position description.

Sharp HealthCare is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability or any other protected class.

#EC

Master's Degree
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