Human Research Protection (HRP) Sr. Program Manager

Company: Guidehouse
Location: Charleston
Posted on: May 28, 2023

Job Description:

Job Family :
Research and Analysis Consulting
Travel Required :
Up to 25%
Clearance Required :
Ability to Obtain Public Trust
What You Will Do :
The HRM Program Manager ensures approved DHA research is conducted in accordance with applicable rules and ethical guidelines to protect the rights and welfare of participants, service members, employees, and their families. The HRP team manages compliance activities for research conducted or supported by DHA that involves human subjects. The team is scaling its activities enterprise-wide so all MTFs will operate under a standardized HRP policy and procedure when DHA assumes administrative oversight of MTFs.

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  Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, Department of Defense (DoD), Food and Drug Administration (FDA), and host nation human subjects protection requirements
  
  
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  Review research protocols that have undergone review and approval by the local Institutional Review Board (IRB)
  
  
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  Delineate deficiencies and areas of regulatory noncompliance and make recommendations regarding regulatory and ethical issues.
  
  
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  Work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for approval
  
  
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  Be assigned a portfolio of protocols for initial review; this includes determinations of not research, research not involving human subjects, exempt research, non-exempt research, and protocols utilizing cadavers/cadaveric specimens
  
  
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  Provide accurate information, assistance, and documents to customers and Federal personnel when requested with appropriate professionalism in a timely manner. *This will require active management of the assigned protocol portfolio; this includes data entry activities and use of specific information management systems to track information and activities related to protocol review
  
  
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  Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research
  
  
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  Assist in the development of local procedures and guidance in the area of human subjects' protection
  
  
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  Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines
  
  
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  Assist in development and implementation of internal operating procedures and review guidelines as requested
  
  
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  Foster regulatory compliance through education and training of investigators, research managers, administrators, and staff, and provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements
  
  
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  Participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing standard operating procedures and work instructions
  
  
  What You Will Need :
  
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    Bachelor's degree
    
    
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    5+ years of related Human Subjects Protection experience
    
    
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    Knowledge of the Federal regulations and ethical principles governing the protection of human research subjects
    
    
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    Knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.
    
    
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    Ability to become proficient in the use of an electronic document management system and Oracle based protocol information management system
    
    
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    Ability to obtain Public Trust
    
    
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    US citizenship required
    
    
    What Would Be Nice To Have :
    
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      Bachelor's degree in Science, Public Health, STEM related field
      
      
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      10+ years of related Human Subjects Protection experience
      
      
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      Experience with the DoD, ideally within the Military Health System
      
      
      The annual salary range for this position is $87,500.00-$175,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
      What We Offer :
      Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
      Benefits include:
      
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        Medical, Rx, Dental & Vision Insurance
        
        
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        Personal and Family Sick Time & Company Paid Holidays
        
        
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        Position may be eligible for a discretionary variable incentive bonus
        
        
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        Parental Leave and Adoption Assistance
        
        
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        401(k) Retirement Plan
        
        
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        Basic Life & Supplemental Life
        
        
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        Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts
        
        
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        Short-Term & Long-Term Disability
        
        
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        Student Loan PayDown
        
        
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        Tuition Reimbursement, Personal Development & Learning Opportunities
        
        
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        Skills Development & Certifications
        
        
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        Employee Referral Program
        
        
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        Corporate Sponsored Events & Community Outreach
        
        
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        Emergency Back-Up Childcare Program
        
        
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        Mobility Stipend
        
        
        About Guidehouse
        Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
        Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
        If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
        Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

Keywords: Guidehouse, Charleston , Human Research Protection (HRP) Sr. Program Manager, Executive , Charleston, West Virginia