Research Regulatory Specialist

MCW: SARGEANT HEALTH CENTER • Milwaukee, WI • 2h ago

JOB REQUIREMENTS: Summary The Research Regulatory Specialist is
responsible for gathering regulatory documents and preparing IRB
applications, amendments, and continuing review submissions for human
subject research, ensuring compliance with Federal, State, and
Institutional Standard Operating Procedures. This role serves as the
regulatory liaison with sponsors, principal investigators, study team
members, and the IRB to support the successful conduct of research
projects. Primary Responsibilities Provide primary administrative
support for the preparation of IRB documents. Assist in drafting and
submitting protocols, protocol summaries, amendments, protocol
deviations, serious adverse events, continuing progress reports, and
consent documents. Modify documents as needed to meet IRB guidelines and
research program requirements. Prepare and submit required documents in
the institution\'s electronic IRB system for initial approval,
amendments, and continuing progress reports. Review submissions for
accuracy, completeness, and compliance using established checklists
prior to submission. Support faculty with Investigator-Initiated IND/IDE
applications. Maintain IRB and FDA regulatory files for each IND/IDE and
ensure required routine monitoring is conducted. Facilitate study
start-up activities, including submissions to committees such as the
Scientific Review Committee, Data Safety Monitoring Board, Institutional
Biosafety Committee, or Radiation Safety Committee. Manage
ClinicalTrials.gov postings as required. Collaborate with Research
Managers, Research Nurses, and Research Coordinators to identify and
complete all regulatory needs for assigned protocols. Identify and
resolve problems or obstacles related to research protocol
implementation. Communicate issues to supervisors and study
investigators. Ensure all regulatory activities comply with applicable
federal and state laws, as well as institutional standard operating
procedures. Assist investigators and research staff with the development
of program materials, including educational materials, marketing
content, websites, forms, and reports. Maintain program timelines by
tracking deadlines for program components. Utilize the institution\'s
Clinical Trial Management System (CTMS) to meet regulatory requirements
and track activities. Collect, analyze, and disseminate program data,
and report progress to stakeholders. Coordinate notifications to study
team members regarding annual regulatory education requirements. Work
with principal investigators to develop, implement, and maintain
comprehensive databases and files related to the research... For full
info follow application link. EEO/AA Minorities/Females/Vets/Disability
The Medical College of Wisconsin is an affirmative action/equal
opportunity employer and does not discriminate in hiring or employment
on the basis of age, sex, race, color, religion, national origin,
veteran status, disability or sexual orientation. *** APPLICATION
INSTRUCTIONS: Apply Online: ipc.us/t/83B2F79D0ABC4991 Qualified females,
minorities, and special disabled veterans and other veterans are
encouraged to apply.

Similar Jobs

Assembly Technician

Toshiba International Corporation • Milwaukee, WI • 47min ago

IT & Engineering

We are Toshiba. We have an unwavering drive to make and do things that lead to a better world. At Toshiba, we commit to raising quality of life for people around the world, ensuring progress that is in harmony with our p...

47min ago

Go to Apply

Manager Northside

NORTH SHORE BANK FSB • Racine, WI • 47min ago

Management & Administrative

JOB REQUIREMENTS: Branch Manager - Northside LinkedIn Twitter Email Message Share Job Location 3911 N Main St, Racine, Wisconsin Tracking Code 6421 Position Type Full-Time/Regular North Shore Bank is about helping famili...

47min ago

Go to Apply

Teller Bilingual Spanish Pay Starting

NORTH SHORE BANK FSB • Milwaukee, WI • 48min ago

Retail & Hospitality

JOB REQUIREMENTS: Teller - Full Time - Bilingual/Spanish - Pay Starting \$19+ DOE LinkedIn Twitter Email Message Share Job Location 4230 W Oklahoma Ave, Milwaukee, Wisconsin Tracking Code 6424 Position Type Full-Time/Reg...

48min ago

Go to Apply

Personal Banker Pay Starting at DOE

NORTH SHORE BANK FSB • Milwaukee, WI • 48min ago

Finance, Accounting & Banking

JOB REQUIREMENTS: Personal Banker - Pay Starting at \$25+ DOE - Bilingual/Spanish LinkedIn Twitter Email Message Share Job Location 4230 W Oklahoma Ave, Milwaukee, Wisconsin Tracking Code 6420 Position Type Full-Time/Reg...

48min ago

Go to Apply

Senior Universal Banker

SUMMIT CREDIT UNION • Waukesha, WI • 48min ago

Finance, Accounting & Banking

JOB REQUIREMENTS: Description At Summit Credit Union, we\'re all about people helping people-while building futures, confidence, and financial wellness along the way. As a Senior Universal Banker at our Waukesha Northeas...

48min ago

Go to Apply

Assistant Director Field Growth

NORTHWESTERN MUTUAL LIFE INSURANCE • Milwaukee, WI • 48min ago

JOB REQUIREMENTS: Summary: Plays an important role as the ambassador and champion for Northwestern Mutual\'s Advisor Value proposition. Expert at expressing the value of affiliation with Northwestern Mutual\'s leader led...

48min ago

Go to Apply

Security Officer Part Time - Bank

Allied Universal • Milwaukee, WI • 51min ago

Finance, Accounting & Banking

Allied Universal®, North America's leading security and facility services company, offers rewarding careers that provide you a sense of purpose. While working in a dynamic, welcoming, and collaborative workplace, you wil...

51min ago

Go to Apply

Financial Planning Performance Analyst

JOHNSON BANK • Milwaukee, WI • 51min ago

Finance, Accounting & Banking

JOB REQUIREMENTS: Overview As a strategic, proactive partner to the LOB executive and senior leadership, the Performance Analyst provides sound, relevant, impactful and timely information by comparing intended outcomes w...

51min ago

Go to Apply

Treasury Support Specialist

WATERSTONE BANK • Waukesha, WI • 52min ago

Finance, Accounting & Banking

JOB REQUIREMENTS: Description The purpose of the Treasury Support Specialist: Under direct supervision of the Chief Retail Officer, this position is responsible for providing support, sales and service to business bankin...

52min ago

Go to Apply

Universal Banker I

WATERSTONE BANK • Oak Creek, WI • 53min ago

Finance, Accounting & Banking

JOB REQUIREMENTS: Description Starting salary for Universal Banker position is \$19.50 an hour and up, depending on experience. What is the purpose of the Universal Banker position... Under direct supervision of an Assis...

53min ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)