Share Email Opening
Title

Research Compliance & Quality Analyst 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
About the Organization The mission of Fenway Health is to enhance the wellbeing of the lesbian, gay, bisexual, and transgender (LGBT) community and all people in our neighborhoods and beyond through access to the highest quality health care, education, research, and advocacy. Fenway Health was founded in 1971 and has grown from a less than 10 person operation in the basement of a building near the Boston Fens to one of the largest LGBT-focused organizations in the world. It consists of three main centers:

• Fenway Community Health Center, our clinical arm, which is a federally qualified health center that operates three clinic sites (Fenway:1340, Fenway:South End, and the Sidney Borum, Jr. Health Center) in the Boston area and provides over 30,000 patients with primary and specialty medical care, behavioral health care, optometry care, and dental care;

• The Fenway Institute, our research/training/education/policy development arm, which houses numerous research initiatives as well as the National LGBT Education Project, the LGBT Aging Project, the National Center for Innovation in HIV Care, and the Center for Population Research in LGBT Health; and

• AIDS Action, our HIV/AIDS service organization, which provides nonclinical services (case management, housing and legal assistance, outreach, peer support) to people living with HIV/AIDS and operates numerous programs focusing on HIV/STD prevention/testing/treatment, including the Access (drug user health program), TransCEND (transgender peer support and risk reduction program), and Youth on Fire (drop-in center for homeless and street-involved youth) programs.
 
Position Research Compliance & Quality Analyst  
Full-Time/Part-Time Full-Time  
Description

Function:
Under the direction of the Manager of Research Integrity & Compliance, performs quality management activities for TFI research, provides operational support to TFI's Internal Monitoring Program, and contributes to the TFI Compliance and Quality team.

Representative Duties:

  1. Implements quality management activities
  • Conduct study audits (informational, routine, and directed) of research protocols
  • Document audit findings, maintain quality control files and support error prevention as appropriate
  • Participate in quality assurance assessments, regulatory audits, and improvement activities under the direction of the Manager of Research Integrity & Compliance
  • Support staff in filing and organization of data related to quality management activities
  • Review Quality Control queries with study coordinators to support timely resolution
  • Assist study teams with preparations for site activation, monitoring and auditing, and closeout visits
  • Develop and implements trainings related to Quality Improvement and Quality Assurance, under the guidance of the Manager of Research Integrity and Compliance
  • Assist with creation of Quality Management tools and templates
  • Perform study start-up and close-out consultations
  • Perform IND/IDE research regulatory consultations for Sponsor Investigators and staff
  • Assist with the development of study quality management plans
  • Address non-compliance by assisting with the development of corrective and preventative action plans
  • Prepare Quality Management Reports for faculty and staff, under the guidance of the Manager of Research Integrity and Compliance, to promote quality improvement
  1. Assists with human research protection program operations
  • Assist, as needed, with Institutional Review Board, Institutional Biosafety Committee, Financial Conflict of Interest, and Research Misconduct administration and operations under the guidance and direction of the Manager of Research Integrity & Compliance
  • Support the pre-review process for IRB as needed
  • Attend monthly IRB meetings and ad hoc IBC meetings as a site resource for board members and to present on any quality management related issues
  • Review the annual check-ins of expedited studies not subject to Continuing Review
  1. Assists with data management and data entry for various research administration databases
  • Assist with data extraction, data entry and quality checking with reasonable speed and accuracy
  • Troubleshoot inconsistencies with data and data collection
  1. Supports TFI Research Compliance training program
  • Audit central staff training file and database
  • Assist with development of TFI standard operating procedures related to Quality Management
  • Create and implement trainings and educational materials related to conduct of research at TFI
  1. Accurately assists in department operational and administrative matters
  • Files, photocopies, faxes, etc. as required for completion of other job duties
  • Performs special projects as assigned
  1. Meets TFI Participatory Expectations
  • Work cooperatively with other FCH departments to facilitate activities of TFI
  • Represent TFI in facility-wide task forces and committees as assigned
  • Attend departmental operations meetings on a quarterly bases to discuss quality management priorities and/or findings
  1. Meets Agency Participatory Expectations
  • Assist with all components of TFI's compliance program
  • Educate all employees on agency and departmental policies and procedures
  • Develop and manages quality assessment and improvement activities
  • Promote the highest principles of patient and client confidentiality
  • Adhere to established safety policies, procedures and precautions; identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation
  • Attend all required meetings, in-services and professional trainings
  • Conduct regular training on issues related to human subject protection, compliance with federal and state regulations and quality management
  • Maintain professional competence necessary to perform job responsibilities; maintains and provides agency with records of continuing education activities
  • Serve on agency committees and in professional organizations when requested
  1. Performs related duties as required

We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 11 paid holidays, paid vacation, and more.
LGBTQ-identified persons, people of color, and others from historically underrepresented communities are encouraged to apply.

 
Number of Openings 1  
Position Requirements

Requirements:

  • Research experience highly desirable
  • QA/QI experience required
  • Quality metric development experience desired
  • Interest in training/public speaking
  • Aptitude for data visualization
  • Experience with all MS Office software
  • Ability to handle multiple tasks and prioritize assigned duties
  • Excellent communication skills, strong attention to detail, and the ability to work independently required
  • Experience working with an ethnically, culturally and racially diverse staff preferred
  • Ability to work harmoniously with diverse groups of individuals required

Physical Requirements:

  • Ability to meet the following physical requirements with or without reasonable accommodations:
  • Sit at a computer station for extended periods of time
  • Ability to keyboard for extended periods of time
 
Category Compliance  
Number Filled 1  
Location The Fenway Institute - Ansin  
Shift -not applicable-  
Req Number COM-18-00003  

This position is currently not accepting applications.

To search for an open position, please go to http://aac.appone.com




Follow us See who works here:
 


 
Click here for technical assistance.