Title: Genomics and Newborn Screening Research Coordinator
Employee Name: TBD
Supervisor: Janice Bach, Manager, Genomics and Genetic Disorders Section (GGDS)
Purpose: This full-time position provides coordination for Michigan Department of Health and Human Services (MDHHS) participation in research studies and special projects involving public health genomics, birth defects, newborn screening (NBS), and the Michigan BioTrust for Health. BioTrust program activities encompass administrative oversight of the research use of residual NBS dried blood spot specimens (DBS). The position is based in the Lifecourse Epidemiology and Genomics Division at MDHHS in Lansing and works closely with genomics, birth defects, NBS follow-up, epidemiology, vital records and laboratory personnel as well as external partners such as the Scientific Advisory Board, Community Values Advisory Board, contractors and researchers nationwide working in academia, clinical settings or the private sector.
Duties and Responsibilities:
Serves as point person to coordinate collaboration on studies involving topics related to public health genomics, birth defects and NBS
Develops procedures for responding to requests for participation in research studies and special projects
Works with relevant staff and external investigators to ascertain role of MDHHS, study aims, protocols, and feasibility
Acquires and maintains expertise on MDHHS internal approval processes
Prepares relevant documents and secures necessary administrative approvals for letters of support, work statements, Institutional Review Board (IRB) applications, data use agreements (DUA) and other required forms
Maintains communication with primary investigators regarding need for IRB revisions and renewals
Works with grant managers to monitor subawards from research partners
Maintains records of correspondence and documents involving research and special studies
Coordinates day-to-day operations of the BioTrust program
Responds to requests for information regarding BioTrust policies, procedures and research application process
Maintains internal communication among bureau directors, NBS laboratory and follow-up staff, IRB, legal and compliance offices
Maintains communication with external partners and stakeholders including advisory committees, contractors, Newborn Screening Translational Research Network and others
Maintains and updates Community Values Advisory Board and Scientific Advisory Board membership
Plans and facilitates advisory boards and internal operations meetings; prepares meeting agendas, documents, meeting summaries and related correspondence
Develops and/or updates program policies and procedures as needed; consults with legal and privacy office personnel as needed
Prepares annual IRB renewal application and revisions for the BioTrust as needed
Monitors national developments and maintains communications with other states, organizations and agencies concerning the use of residual DBS
Provides presentations in local, state and national venues as requested
Maintains records and correspondence relating to BioTrust operations
Administers the application, review and approval process for research studies requesting use of Michigan residual DBS held by the BioTrust
Responds to specific inquiries concerning availability of blood spots and relevant data
Processes incoming research applications to ensure completeness
Provides detailed review of study proposals regarding compliance with human subjects’ protections, scientific merit, documentation of institutional IRB approval, and need for data use and material transfer agreements; communicates findings to investigators
Facilitates formal review process through program directors; MDHHS IRB; scientific advisory board review panels; programs responsible for data (eg NBS, Vital Records, Michigan Cancer Surveillance Program, and Michigan Birth Defects Registry); and compliance office requirements
Assures execution of appropriate Material Transfer Agreements and DUAs with researchers, their institutions and MDHHS
Coordinates identification of appropriate specimens by NBS staff and contractors for retrieval/de-coding before release to researchers
Participates in educational outreach to promote BioTrust parent and community awareness, understanding and engagement
Collaborates with NBS Follow-up personnel to incorporate training for hospital staff and homebirth attendants administering the BioTrust consent process
Provides technical assistance on consent form processing procedures to assure quality measures per IRB requirements
Identifies opportunities to promote community awareness and engagement; participates in grand rounds, exhibits, lectures, social media posts and articles as requested
Identifies relevant statewide organizations and recruits members for participation on the Community Values Advisory Board (CVAB); assists with coordination of educational outreach through CVAB member organizations.
Acquires expertise on federal Office for Human Research Protections requirements and the Common Rule
Monitors status regarding implications for human subjects and research study participation
Recommends changes in BioTrust policies as needed to ensure compliance with federal regulations on informed consent
Participates in departmental initiatives and planning regarding research involving genomics, birth defects, NBS or BioTrust program activities; attends relevant meetings with internal staff and external stakeholders to assure collaboration and coordination with other programs
Attends relevant section, division and departmental staff meetings
Performs other tasks as requested to ensure successful implementation of programs
Maintains a positive, strong, credible, professional and interpersonal relationship with all parties relevant of MPHI projects, and represents the best interest of MPHI at all times
Education: Master’s degree in public health, biological or health science such as human genetics, genetic counseling, or nursing is preferred. Candidates with a Bachelor’s degree in genetics or other relevant health/laboratory science may be considered with minimum three years of relevant work experience.
Experience: Minimum one year of relevant work experience (such as project or study coordinator, research assistant, or IRB coordinator) in a health research, public health, or clinical setting; or laboratory setting (such as scientist or technologist).
Required Skills and Characteristics: Must have ability to understand and interpret complex scientific research protocols relating to a variety of topic areas including birth defects, newborn screening, cancer genomics, clinical diseases, molecular genetics and environmental exposures; ability to understand genetic and genome sequencing terminology; knowledge of regulations and ethical issues pertaining to human subjects research; experience with IRB submission and approval processes; ability to understand data, use databases and spreadsheets for maintaining records; familiarity with biobanking, storage procedures and policies for Michigan BioTrust; ability to develop new contacts and maintain positive working relationships; ability to utilize knowledge to provide consultation and technical assistance; experience with health education and outreach methods; and ability to prepare articles and reports suitable for publication and/or posting to program websites. Excellent public speaking, data management, organizational, MS Office Software, writing skills, and ability to prepare reports and correspondence are essential. Attention to detail is imperative for this position.
WorkEnvironment and PhysicalRequirements: Standard office environment. Involves significant computer related activity including keyboarding and viewing a computer screen; occasional telephone communication. Job may occasionally require moderate physical effort such as lifting and transporting handout materials, laptop computer and projector, etc. Requires valid vehicle operator’s license and occasional travel to other areas of the state for meetings and presentations; possible out-of-state travel for relevant conferences.
RESPONSIBILITY FOR THE WORK OF OTHERS:
No assigned responsibility.
IMPACT ON PROJECTS, SERVICES AND OPERATIONS
This position plays a critical role in assuring successful collaboration with research investigators as well as implementation of the BioTrust program.
1. GGDS and NBS Follow-up Section Managers
Daily to weekly
Coordinate and oversee work.
2. Bureau of Epidemiology and Population Health and Bureau of Laboratories directors
Bi-weekly and as needed
Clarify questions and obtain direction on BioTrust policies and procedures; secure approvals to proceed with review of specific research study proposals.