PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The Fenway Institute (TFI) is an interdisciplinary center for research, training, education, and policy development, focusing on national and international health issues housed within Fenway Community Health. Our mission is to ensure access to quality, culturally competent medical and mental health care for traditionally underserved communities, including lesbian, gay, bisexual and transgender (LGBT) people and those affected by HIV/AIDS.
In keeping with TFI's commitment to research excellence, we're looking for a dynamic individual to work with research staff to ensure compliance with regulations and standards governing human research and to provide outstanding support and education to the research community. The Compliance and Quality analyst will play an essential role in ensuring that investigators and study staff have the knowledge and tools to conduct their work in compliance with relevant research requirements.
The full-time Research Compliance and Quality Analyst provides operational support to TFI’s Internal Monitoring Program, and contributes to the TFI Compliance and Quality team.
Perform and manage onsite audits of IRB-approved clinical research protocols to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), Fenway Health policy, and TFI SOPs, including communicating with Principal Investigator and designated staff, planning onsite review strategy, writing onsite review report, and ensuring follow-up is complete.
Develop quality assurance and quality improvement tools for the research community
Assist with development of and participate in orientation and education for TFI research staff and faculty
Provide guidance, resources, and education to investigators and clinical research staff regarding relevant federal, state, and institutional policies and procedures, and study start-up
Provide Regulatory Binder and General Study consultations
Assist with development, implementation, and maintenance of systems to support ongoing QI activities
Remain current on federal, state, and local laws governing human subject research including attendance at conferences, workshops, seminars, or lectures pertaining to human subject research
LGBTQ-identified persons and people of color are encouraged to apply.
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
Internal Number: PUB-18-00011
About Fenway Health
The mission of Fenway Health is to enhance the wellbeing of the lesbian, gay, bisexual and transgender community and all people in our neighborhoods and beyond through access to the highest quality health care, education, research and advocacy.