Regulatory Affairs Assistant Jobs in Racine, WI (NOW HIRING)

Summary
The Medical College of Wisconsin (MCW) is advancing an enterprise-wide transformation of clinical trial activation designed to reduce unnecessary delays, strengthen quality, improve transparency and accountability, and make it easier for investigators to bring promising studies to patients and research participants.
The Director, Clinical Trial Activation & Quality Office, provides senior operational leadership and strategic direction for the development, growth, and sustainability of the enterprise clinical trials portfolio. The Director will have a unique opportunity to oversee an integrated activation team and shape the systems, data, quality framework, and operating model that support MCW's growing clinical research portfolio.
The Director is a vital contributor and subject matter expert across the research mission, liaising with research leadership and the leadership of clinical partners to help steer strategic decision making, as well as developing strong partnerships with internal and external stakeholders as it relates to the operation and execution of efficient clinical trial activation and overall quality.
Reporting to the Assistant Dean, Research Operations, the Director serves as the primary operational advisor to Office of Research leadership on activation performance, quality, infrastructure, and emerging risks. The Director works across the Office of Research, academic departments, clinical partners, and other institutional functions to establish shared accountability, resolve barriers, and improve the end-to-end activation experience.
The Director leads the Activation and Quality Office, overseeing the clinical trials budget development team, managing infrastructure needs, and ensuring high-quality operations. The Director plays a critical role in measuring data-driven goals, ensuring standardization and transparency along the activation pipeline.
Primary Responsibilities

• Lead MCW's centralized clinical trial activation function, creating an integrated, transparent, and accountable approach to advancing studies from initial intake and feasibility through budget, contract, regulatory, ancillary review, and activation, interfacing with other institutional units and partners providing activation support, such as Cancer Center, FT, and CW.
• Direct program development, strategy, organizational development, long range planning, change management, and implementation of the infrastructure, processes and systems necessary to scale efficient, safe, and high-quality clinical trials at MCW.
• Develop and monitor data-driven metrics to ensure efficient clinical trial activation, organizational transparency, stakeholder accountability, and opportunities for enhancement and improvement.
• Analyze activation performance against institutional goals and national benchmarks to identify delays, recurring bottlenecks, variation across departments and study types, and opportunities for improvement; translate findings into recommendations for corrective action.
• Identify, clarify, and resolve strategic impact issues with college wide impact which may span multiple areas, using advanced clinical trials and Good Clinical Practice knowledge requiring broad discretion and judgement.
• In partnership with key stakeholders, assess and guide enterprise clinical trials infrastructure, including staffing levels, applications and software, and other items of organizational or fiscal impact.
• Lead, develop, and mentor the Quality Office function; establish clear roles, service expectations, performance standards, and a culture of collaboration, accountability, continuous learning, and responsive support.
• Oversee the operation of the centralized clinical trial budget development team,
• Ensure ongoing compliance and adherence to quality standards and federal and institutional policies, monitoring and addressing issues and mitigating risks.
• Participate on appropriate committees relevant to the advancement of the MCW clinical trials portfolio, and serve as a subject matter expert and liaison with institutional leaders, administration, faculty, other departments, affiliates, outside institutions, and national organizations.
• Lead the continuous improvement of clinical research resources including workflows, tools, and SOPs with a focus on standardization, cost-effectiveness, productivity, and compliance.
• Participate in and support internal and external meetings, site visits, and special events.
• Other duties as assigned.

Knowledge - Skills - Abilities

• Extensive experience with clinical research operations. Advanced working knowledge of study start-up activities (i.e., feasibility, budget development, contract negotiation and regulatory affairs)
• Extensive experience in research program development. Superior organizational and change management skills. Advanced communication, presentation and negotiating skills.
• Excellent management skills. Proven leadership, mentoring and supervisory skills. Ability to delegate tasks appropriately, influence behavior and drive performance.
• Cultural awareness, customer focus, building trust, communication, critical thinking, and influencing skills are essential.
• Proficient with use of research systems including OnCore Clinical Trials Management Software, TrialConnX, Epic, Florence eBinders, and other tools. Ability to understand system integrations and connectivity.

Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education: Bachelor's degree
Minimum Required Experience: 10 years of clinical research operations management experience
Preferred Education: Masters Degree
Preferred Experience: Extensive experience in research program development and management. Extensive experience with clinical research operations. Research related activities at an academic medical center with clinical research activity. Recognized certification (e.g., ACRP or SOCRA) preferred.
Required Certification/Licensure(s): Certified Clinical Research Coordinator by ACRP or SOCRA preferred or must be obtained within 2 years of employment
Preferred Certification/Licensure(s):
Physical Requirements
Work requires occasionally lifting moderate weight materials, standing, or walking continuously.
Work Environment
Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is 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.
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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.