Insight Health System is a physician-led organization focused on advancing excellence in healthcare and community well-being. Our expertise is in transforming distressed hospitals into stable, patient-centric care that is second to none. With a track record for innovation in healthcare, research and development, Insight Health System provides the communities we serve with world-class healthcare services at the forefront of medical technology. Our network currently includes a portfolio of entities encompassing six acute care hospitals (three of which are nonprofit), six surgery centers, 28 clinics, 580 physicians, 10 unions, and 4,200 employees. Collectively, Insight Health System hospitals provide nearly 100,000 patient days annually.

Employment Type: Full Time Onsite: Insight Research Institute at Insight Chicago location Schedule: 8-5 pm

Benefits for our Full Time Team Members:

Comprehensive health, dental, and vision insurance coverage

Paid time off, including vacation, holidays, and sick leave

401K with Matching; offerings vested fully @ 3 months of employment paired with eligibility to contribute

Short & Long Disability, and Life Term insurance, complementary of Full Time Employment

Additional Supplementary coverages offered @ employee's elections: Accident, Critical Illness, Hospital Indemnity, AD&D, etc.

Job Summary

We are seeking an experienced Director of Clinical Trials Operations to collaborate with Research leadership to support and facilitate clinical Research/Trials Operations at Insight Hospital and Medical Center Chicago. This role is ideal for an individual who can motivate cross-functional teams to collaboratively work together to produce the best quality outcome and foster positive relationships. The Director of Clinical Trials Operations will be responsible for building the infrastructure and managing clinical trials operations for the department. The role will also include supporting the operational needs of research, onboarding and training, as well as contributing to the planning and strategic development of new initiatives and large projects. This role demands excellent communication skills, prior exposure to clinical trials operations at multiple capacities, strong project management skills, and the ability to drive and follow through on multiple complex projects in parallel. The Director will collaborate with both internal and external stakeholders to ensure smooth and efficient operations in support of the research mission.

Job Duties

Support the Chief Research Officer in defining and carrying forward strategic objectives at the organizational level. Provide regular updates on clinical trials, staff, key performance indicators, timelines, and deliverables.

Provide oversight, management, and leadership for the Clinical Research Site Operations at Insight Chicago. Oversee all phases of clinical trials, from initial planning and site selection to study close-out.

Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training.

Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies.

Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations.

Ensure optimal recruitment strategies for the clinical trials, and implementation, and adoption of needed systems.

Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects.

Establish excellent relationships between widely varying stakeholders. Utilize critical thinking and problem-solving abilities to collaboratively overcome challenges and innovate solutions. Maintain diligent communication to ensure that multiple projects can be managed simultaneously and be completed on time, within scope, and within budget.

Collaborate with research leadership to support budgeting, projections, business development, and financial tracking related to research operations. Ensure alignment of projects and expenditures with strategic initiatives and project, departmental and institutional goals.

Propose and drive innovative improvements to procedures and operations to maximize efficiency and productivity. Participate in personnel planning and recruitment to ensure that the department has the interdisciplinary support and expertise needed to succeed.

Collaborate closely with Insight Hospital personnel at all levels including cross-functional leadership, departmental/institutional shared resources, and partner/vendor organizations, to optimize efficiency, productivity and foster innovation.

Overseeing relationships with principal investigators, external vendors, Sponsors, CROs, and other research-related service providers.

Ensuring that all clinical trials are conducted in accordance with relevant regulations (FDA, GCP, ICH), company SOPs, and industry best practices. Review and approve applicable policies and SOPs and work closely with team members to create and improve these documents.

Perform additional activities as required.

Qualifications

10+ years of industry experience in relevant fields is required.

Significant experience in clinical research site operations managing teams in a leadership capacity with focus on both achievement of objectives as well as critical skill-building preferred.

Prior experience in building external connections with peers, emerging technology communities and sponsors.

Experience driving research objectives across areas through collaboration with internal and external stakeholders is preferred.

Proven performance in earlier roles/comparable roles.

Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials

Proficiency in MS Office including Project, PowerPoint, Word, Excel and CTMS

Excellent interpersonal communication skills

Strong analytical and reasoning skills

Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement

Ability and willingness to travel for work related trips

Insight is an equal opportunity employer and values workplace diversity!

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