The Minneapolis Heart Institute Foundation® (MHIF) is seeking a Director, Clinical Research Operations Effectiveness to contribute to MHIF’s vision of creating a world without heart and vascular disease. To achieve this bold vision, we are dedicated to improving the cardiovascular health of individuals and communities through innovative research and education. Now entering our 40th year, MHIF is recognized globally as a research leader in the broadest range of cardiovascular medicine with cutting-edge science centers.
To achieve the mission of MHIF and ensure the effective and efficient delivery of clinical research, this pivotal role helps maximize the time and talent of research coordinators and ensure excellence. The focus of this role is dedicated to building and retaining consistency and sustainability of clinical research processes, advancing new hire contribution and equipping existing team members with continued learning opportunities. Working in collaboration with clinical research leadership, this leader engenders a learning culture and engages the spirit of continuous improvement for excellence and results for patients. Some initial focus areas will include:
- Build accountability systems/methods to ensure operational sustainability
- Facilitate clinical research goal setting and results evaluation aided by benchmarking data
- Ensure resource infrastructure that supports and aligns with organizational goals.
Reporting to the Vice President, Clinical Research Operations, you can make a significant difference to the success of the clinical research team in this transformational role.
- Continuous improvement in clinical research operations. With Clinical Research (CR) leaders, spearheads the identification and prioritization of processes in need of streamlining, identifying limitations and ongoing updates or revisions as they arise. Builds a plan to accomplish this, which may include the leader facilitating process improvement/Lean sessions and/or building continuous improvement skills in others to enable ongoing process improvement. Creates visual accountability systems to keep the CR team on track and build enthusiasm.
- Standard operating procedures (SOP’s). Create and implement operational SOPs as needed. In collaboration with Regulatory, Quality and Compliance, identify the critical SOP’s which need to be created or updated. Conduct annual review and training as applicable.
- Onboarding and Training program. With the help of content experts, oversees onboarding training content development, assessments and revisions. Determines how onboarding and training will be delivered and determines how quality of knowledge transfer should be assessed. Conducts train-the-trainer/mentor sessions.
- Talent Optimization. Conducts annual or bi-annual review of the levels of talent in the clinical research team to ensure a good mix of team members, assessing various learning levels and skill sets to recommend staffing models that meet the needs of clinical research now and for the future. Identifies needs/gaps and translates that into training and hiring plans for the overall broader team.
- Change Management and Accountability. With the Clinical Research Managers, assesses how the operational improvements affect research roles. Builds in change management steps into training and communication for staff. Also, recommends ways to ensure understanding and accountability measures that will sustain change initiatives.
- Goal Setting. With the VP of Clinical Research Operations, builds a planning and goal setting process for the Clinical Research team that involves the managers, provides templates for individual goal setting and standards of performance.
- In this systems-thinking role, will work closely with the VP of Clinical Research Operations on other strategic projects and planning and analysis endeavors.
- Bachelor’s Degree in healthcare or biologic-related, medical or nursing sciences
- Strong command of clinical trial acumen
- Clinical Research Coordinator/Professional (CCRC or CCRP) certification
- A minimum of 3 years of experience leading clinical research projects with a successful track record of initiation, execution and completion
- Lean/Six Sigma certification or equivalent experience. Ability to facilitate and lead improvement/Lean sessions
- Experience in assessing learning needs, designing training and facilitating meetings and training sessions
- Skilled in assessing workflow, evaluating talent and resources needed and aligning teams and talents with work. Systems and process thinker
- Experience in designing remediation plans to address productivity and efficiency issues, with a record of follow through to ensure closure
- Versatile and excellent interpersonal and influence skills with a wide range of employees and stakeholders with examples of serving as a change agent
- History of exhibiting personal leadership, contributing positively to communications, and collaborating effectively across the organization
- Excellent written communication and content development skills
- Expertise and working knowledge of cardiovascular diseases and therapies
- Project and product management skills; PMP certification a plus
- High learning agility, goal-oriented, self-directed in work and learning and development
- This individual is motivated by seeing teams and leaders succeed
- Evidence of being self-aware with emotional maturity, self-management and poise under pressure
- Supervisory experience ideally leading clinical/medical personnel e.g. hiring, training, coaching, developing and assessing performance of team members
Join our talented 80+ person team:
Please apply online using the link below and be prepared to attach a cover letter and resume as one document.
Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.
Date posted: November 23, 2021