Research Compliance Specialist

Posted: 10/17/2022

Reporting to the Director of Research Compliance, the Research Compliance Specialist is responsible for the administrative operations of Research Compliance and supporting The Fenway Institute's Quality Management (QC, QA, QI) activities. Research Compliance oversees Human Research Participant Protection at Fenway Health. This includes the Institutional Review Board (IRB), charged with the ethical oversight of human subject research; Institutional Biosafety Committee (IBC), that reviews recombinant DNA studies for community and environmental safety; TFI Internal Monitoring (TIM) that facilitates research quality assurance and quality improvement; Financial Conflict of Interest Review, that ensures objectivity in research; and Research Integrity, that handles any allegations of research misconduct.

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Representative Duties:

IRB & IBC Operations and Administration (80%)

  • Handles technology and operations for monthly IRB meetings & ad hoc IBC meetings (minutes, determination letters, etc.)
  • Pre-reviews submissions for completeness and consistency
  • Supports the boards' pre-review process and shares electronic submissions with the boards
  • Prepares meeting agenda and meeting attendance logs
  • Maintains IRB regulatory files in compliance with federal regulations
  • Coordinates and tracks IRB member trainings
  • Maintains membership rosters
  • Prepares FWA and IORG filings for IRB and OSP filings for IBC

Financial Conflict of Interest Operations and Administrations (5%)

  • Oversees the annual research conflict disclosure campaign
  • Assigns disclosures to designated reviewers, and tracks disclosures
  • Prepares annual conflict assessment letter
  • Manages technology and operations for ad hoc Financial Conflict of Interest meetings

Support TFI's Research Compliance Quality Management Activities (13%)

  • Maintains SOP files for TFI
  • Coordinates required research training for all TFI staff members in accordance with Staff Training policy
  • Maintains central staff training file and database
  • Provides documentation of training and regulatory compliance as needed to study sponsors and regulatory agencies
  • Conducts staff trainings on issues related to human subject protection, HIPAA, and Cayuse (online IRB platform)
  • Support preparation for third party auditing and monitoring of research studies, and the conduct of for-cause internal study monitoring
  • Track research compliance departmental metrics in RedCap
  • Provide administrative support for research integrity investigations
  • Assist with data extraction, data entry and quality checking with reasonable speed and accuracy

Meets Agency Participatory Expectations (2%)

  • Suggests and participates in continuing quality improvement efforts 
  • Adheres to all agency and departmental policies and procedures
  • Participates in quality assessment and improvement activities as requested
  • Adheres to the highest principles of patient and client confidentiality
  • Adheres to established safety policies, procedures and precautions; identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation
  • Attends all required meetings, in-services and professional trainings
  • Attends all regularly scheduled research meetings, trainings, forums and pertinent FCH staff meetings
  • Maintains professional competence necessary to perform job responsibilities; maintains and provides agency with records of continuing education activities
  • Serves on agency committees and in professional organizations when requested

Performs other related duties as required

 

Requirements

 

  • Resourcefulness, kindness, and a collaborative spirit are essential to this role.
  • Ability to work independently
  • Meticulous Attention to Detail
  • Proficiency with all MS Office suite
  • Ability to handle multiple tasks and prioritize assigned duties
  • Bachelor’s degree or 4 years equivalent work experience in a related field
  • 1- 2 years of work experience in clinical research/research compliance
  • Ability to work harmoniously and effectively with colleagues, patients, clients and vendors across the spectrum of diversity, including but not limited to race, ethnicity, color, gender identity, sexual orientation, age, socio-economic status, national origin and immigrant status, religious or spiritual identity, disability (physical, mental, emotional and developmental), veteran status, and/or limited English proficiency.
  • Willingness to contribute towards Fenway’s efforts in becoming an anti-racist organization and promoting a culture dedicated to ongoing development in service of humility, equity, diversity, inclusion, and belonging, where differences are acknowledged and valued.

Preferred Qualifications:

  • Research experience, regulatory/compliance experience, CIP, or related degree highly desirable
  • Knowledge of HHS & FDA Human Subject Protection Regulations
  • Familiarity with GCP
  • Proficiency with RedCap
  • Excellent written and spoken communication skills 

Physical Requirements:

Ability to meet the following physical requirements with or without reasonable accommodations:

  • Sit or stand at a computer station for extended periods of time
  • Ability to keyboard for extended periods of time
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 12 paid holidays, paid vacation, and more.LGBTQIA+ identified persons, Black, Indigenous, and other people of color (BIPOC), and individuals from other historically underrepresented communities are strongly encouraged to apply.

Highly experienced individuals may be compensated at a higher rate.

 

Internal ID: TFI-23-FT-9