IRB Coordinator III - Reliance - Research Office
Medical College of Wisconsin, Milwaukee, WI, United States
Summary
The Office of Research helps tofacilitatelife-saving biomedical research at the Medical College of Wisconsin. Nine distinct units provide specialized support to meet the administrative needs of our investigators and research staff, and together we coordinate, regulate, and monitor research studies. Our Human Research Protection Program Office oversees safe, ethical, compliant conduct of humansubjectsresearch via our Institutional Review Boards (IRBs).
The IRB Coordinator III, Reliance,is responsible formonitoring and ensuring complianceincertainsituations where MCW, multiple sites, or external organizations rely on another IRB for study review, approval, andcontinuingoversight. The IRB Coordinator III, Reliance,routinely applies working knowledge of theOffice for Human Research Protections (OHRP)regulations and guidance,Federalregulations,and Institutional Standard Operating Proceduresto evaluate and manage reliance requests.
Primary
Responsibilities
Serve astheMCWpoint ofcontact for reliance andsingle IRB (sIRB)requests.Field phone callsand other inquiriesand respond to inquiries for IRB Managers.
Triage inquiries for reliance andsIRBrequests;manage MCW IRB Reliance email inbox, escalate toRelianceManageras needed.
Independently consultwith Investigatorsandstudyteams toensure reliance requests are complete andaccurate,provide suggestions for improvements andmodifications,and request changes as needed.
Review and process external notifications and requests from other IRBs..
Review and process commercial notifications and notifications of issues identified with other IRBs (e.g.serious or continuing noncompliance, UPRISOs), advising study teams whenadditionalaction is required.
Process staff changes and site preferencesfor NCI CIRB.
Process closure reports for projects where MCW as a site isclosingor the projectis closing in its entirety.
Notify external sites when a project that has MCW serving as IRB for an external site has closed.
Working with the Reliance Manager, prepare andsubmitannualNCI CIRBand NMDPIRBannualsignatory worksheets.
Review and process reliance requests within the parameters of existing agreements and MCW IRB oversightjurisdiction.
Execute reliance agreements according to MCW SOP,FDAand OHRP Regulations.
Develop andrepresentthe HRPP Office as a presenter and subject matter expert atreliance andsIRBrelated educational sessions.
Attend national & local consortia meetings in support of MCW participation within these organizations.
Support intake ofnew reliance requestsfor projects relying on an external IRB, and for projects where MCWisasthesIRB.
Review reliance requests for accuracy and completeness to ensure compliance with IRB SOPs,OHRPand Federal Regulations.
Request modifications
Ensureall required elements are present and generate a synopsis.
Preparereliancedecisionlettersas needed
Utilize and enhancetools to track and report metrics on reliance andsIRBrequests.
Resolve moderately complex issues involving more advanced research.
Apply thoughtful logic and sound reasoning when evaluating reliance andsIRBrequests.
Otherduties asassigned to support HRPP initiatives.
Knowledge - Skills - Abilities
A demonstrated working knowledge of the federal regulations governing human subjects research is required.Exceptional analytical ability is necessaryin order toapply knowledge of federal regulations and institutional policy to research submissions.
Excellent oral and written communication skills are essential, with a demonstratedability to organize, write about and discuss regulatory and complex issues clearly.
Computer proficiency isrequired, including MS Word, Excel,Teams,internet browsers, and email. The IRB review process is conducted via an electronic web-based system, which will require individuals to be comfortable reading on a screen and to easily switch back and forth between screens to obtain and synthesize information.
Ability to work independently and as part of an inter-dependentteam. Ability to effectively plan and organize projectsand reviews. Ability to work within a deadline-driven environment.
Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education:
Bachelor's Degree
Minimum Required Experience:
5 years
Physical Requirements
Work requires infrequent physical effort such as walking or retrieving materials.
Work Environment
May experience slightly disagreeable features such as temperature changes or noise from time to time. Work performed in an environmentally controlled environment.
Sensory Acuity
Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.
#LI-AV1
Why MCW?
Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
403B Retirement Package
Competitive Vacation and Paid Holidays offered
Tuition Reimbursement
Paid Parental Leave
Employee & Family Assistance Program (EFAP)
Pet Insurance
On campus Fitness Facility, offering onsite classes
Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.
For a brief overview of our benefits see:
Benefits Overview
For a full list of positions see:
MCW Careers
At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our
institutional website .
MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.
The Office of Research helps tofacilitatelife-saving biomedical research at the Medical College of Wisconsin. Nine distinct units provide specialized support to meet the administrative needs of our investigators and research staff, and together we coordinate, regulate, and monitor research studies. Our Human Research Protection Program Office oversees safe, ethical, compliant conduct of humansubjectsresearch via our Institutional Review Boards (IRBs).
The IRB Coordinator III, Reliance,is responsible formonitoring and ensuring complianceincertainsituations where MCW, multiple sites, or external organizations rely on another IRB for study review, approval, andcontinuingoversight. The IRB Coordinator III, Reliance,routinely applies working knowledge of theOffice for Human Research Protections (OHRP)regulations and guidance,Federalregulations,and Institutional Standard Operating Proceduresto evaluate and manage reliance requests.
Primary
Responsibilities
Serve astheMCWpoint ofcontact for reliance andsingle IRB (sIRB)requests.Field phone callsand other inquiriesand respond to inquiries for IRB Managers.
Triage inquiries for reliance andsIRBrequests;manage MCW IRB Reliance email inbox, escalate toRelianceManageras needed.
Independently consultwith Investigatorsandstudyteams toensure reliance requests are complete andaccurate,provide suggestions for improvements andmodifications,and request changes as needed.
Review and process external notifications and requests from other IRBs..
Review and process commercial notifications and notifications of issues identified with other IRBs (e.g.serious or continuing noncompliance, UPRISOs), advising study teams whenadditionalaction is required.
Process staff changes and site preferencesfor NCI CIRB.
Process closure reports for projects where MCW as a site isclosingor the projectis closing in its entirety.
Notify external sites when a project that has MCW serving as IRB for an external site has closed.
Working with the Reliance Manager, prepare andsubmitannualNCI CIRBand NMDPIRBannualsignatory worksheets.
Review and process reliance requests within the parameters of existing agreements and MCW IRB oversightjurisdiction.
Execute reliance agreements according to MCW SOP,FDAand OHRP Regulations.
Develop andrepresentthe HRPP Office as a presenter and subject matter expert atreliance andsIRBrelated educational sessions.
Attend national & local consortia meetings in support of MCW participation within these organizations.
Support intake ofnew reliance requestsfor projects relying on an external IRB, and for projects where MCWisasthesIRB.
Review reliance requests for accuracy and completeness to ensure compliance with IRB SOPs,OHRPand Federal Regulations.
Request modifications
Ensureall required elements are present and generate a synopsis.
Preparereliancedecisionlettersas needed
Utilize and enhancetools to track and report metrics on reliance andsIRBrequests.
Resolve moderately complex issues involving more advanced research.
Apply thoughtful logic and sound reasoning when evaluating reliance andsIRBrequests.
Otherduties asassigned to support HRPP initiatives.
Knowledge - Skills - Abilities
A demonstrated working knowledge of the federal regulations governing human subjects research is required.Exceptional analytical ability is necessaryin order toapply knowledge of federal regulations and institutional policy to research submissions.
Excellent oral and written communication skills are essential, with a demonstratedability to organize, write about and discuss regulatory and complex issues clearly.
Computer proficiency isrequired, including MS Word, Excel,Teams,internet browsers, and email. The IRB review process is conducted via an electronic web-based system, which will require individuals to be comfortable reading on a screen and to easily switch back and forth between screens to obtain and synthesize information.
Ability to work independently and as part of an inter-dependentteam. Ability to effectively plan and organize projectsand reviews. Ability to work within a deadline-driven environment.
Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education:
Bachelor's Degree
Minimum Required Experience:
5 years
Physical Requirements
Work requires infrequent physical effort such as walking or retrieving materials.
Work Environment
May experience slightly disagreeable features such as temperature changes or noise from time to time. Work performed in an environmentally controlled environment.
Sensory Acuity
Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.
#LI-AV1
Why MCW?
Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
403B Retirement Package
Competitive Vacation and Paid Holidays offered
Tuition Reimbursement
Paid Parental Leave
Employee & Family Assistance Program (EFAP)
Pet Insurance
On campus Fitness Facility, offering onsite classes
Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.
For a brief overview of our benefits see:
Benefits Overview
For a full list of positions see:
MCW Careers
At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our
institutional website .
MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.