Senior Research Regulatory Specialist - Pediatrics

Medical College of Wisconsin•Milwaukee, WI

18h

About The Position

The Senior Research Regulatory Specialist coordinates day-to-day administrative activities for the clinical research trials program, including regulatory submissions and compliance for human subject research. The role mentors and leads Research Regulatory Specialists and/or Coordinators, and serves as a regulatory liaison among sponsors, principal investigators, study team members, and review committees. It supports the achievement of Cancer Center CTO goals and helps ensure compliance with federal and state regulations, institutional policies, and standard operating procedures. The specialist prepares and submits research documents, supports study start-up and Investigator-Initiated IND/IDE applications, maintains regulatory files, and advises research teams on protocol-related regulatory needs. The role also tracks program timelines and activities, gathers and reports program data, contributes to program materials, identifies process improvements, and manages special projects with minimal supervision.

Requirements

Bachelor’s degree; appropriate experience may be substituted for education on an equivalent basis.
At least 4 years of experience in a compliance or healthcare field.
CITI certification within 30 days of hire.
Knowledge of biology, chemistry, mathematics, documentation, regulatory compliance, interpretation of regulations, and records management.
Oral and written communication skills.
Critical thinking, problem-solving, and attention to detail.
Data utilization and resource management skills.

Nice To Haves

SoCRA and/or ACRP Certified Clinical Research Professional certification, preferred within 6 months of employment or promotion.

Responsibilities

Coordinate day-to-day administrative activities of the clinical research trials program.
Mentor and lead Research Regulatory Specialists and/or Coordinators.
Draft and submit protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents with minimal supervision.
Prepare or guide preparation and modification of IRB documents in accordance with IRB guidelines.
Prepare or guide preparation of documents in the MCW/Froedtert electronic IRB system for initial approval, amendments, and continuing progress reports.
Review submissions for accuracy and completeness, identify problems, and perform quality control using established checklists before IRB submission.
Coordinate support for Investigator-Initiated IND/IDE applications; maintain related IRB and FDA regulatory files and ensure routine monitoring is conducted as required.
Manage study start-up activities as needed, including submissions to the SRC, DSMB, Institutional Biosafety Committee, Radiation Safety Committee, and MRI Committee, as well as ClinicalTrials.gov postings.
Advise CTO Research Managers, Research Nurses, Research Coordinators, and other study team members on identifying, prioritizing, and completing protocol regulatory needs, including annual regulatory education requirements.
Ensure regulatory activities comply with applicable federal and state laws and institutional standard operating procedures.
Collaborate with investigators and CTO Research nurses/study coordinators to develop program materials, including educational and marketing materials, websites, forms, databases, and reports.
Maintain program timelines and track deadlines for program components.
Use MCW’s Clinical Trial Management System (CTMS) OnCore to support regulatory requirements and track activities.
Collect, analyze, and disseminate program data, and report program data and progress to stakeholders.
Identify system or procedural obstacles affecting research protocol implementation and communicate proposed solutions or process improvements to the supervisor and study investigators.
Manage special projects assigned by the Manager and/or CTO Leadership with minimal supervision.
Perform other duties as assigned.

Benefits

Outstanding healthcare coverage, including health, vision, and dental insurance.
Flexible Spending options.
403B retirement package.
Competitive vacation and paid holidays.
Tuition reimbursement.
Paid parental leave.
Employee & Family Assistance Program (EFAP).
Pet insurance.
On-campus fitness facility with onsite classes.
Discounted rates on select cell phone plans, local fitness facilities, Milwaukee recreation, and entertainment.