Clinical Research Director Jobs

About The Position

Requirements

• 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.
• Bachelor’s degree
• 10 years of clinical research operations management experience

Nice To Haves

• Masters Degree
• 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.
• Certified Clinical Research Coordinator by ACRP or SOCRA preferred or must be obtained within 2 years of employment

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.

Benefits

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental.
• 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.