Clinical Research Operations Manager

Ann & Robert H. Lurie Childrens Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence kids and their families are at the center of all we do. Ann & Robert H. Lurie Childrens Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

The Clinical Research Operations Manager plays a critical role in overseeing the day-to-day operations of research programs ensuring regulatory compliance operational efficiency and timely execution of research projects. This individual will manage cross-functional teams coordinate research start-up activities and act as a liaison between investigators sponsors regulatory bodies and administrative units.

This role will partner with Sponsor/CROs Principal Investigators OCCT clinical research services and finance service lines ancillary support service areas and other key stakeholders to facilitate the ongoing operational support of clinical trials.

The Clinical Research Operations Manager serves as the primary contact for their designated area and ensures that researchers are provided with high quality efficient responsive and responsible research administration services. Strong communication and presentation skills will be a must. As a representative of the OCCT in institutional committees and workgroups the Clinical Research Operations Manager will require a broad range of clinical research operations finance and technology knowledge and the ability to communicate the needs of the research community. This detail-oriented individual thrives in a fast-paced environment successfully juggling competing demands to competitively activate clinical trials for all departments and divisions across the hospital.

Essential Job Functions:

Lead and manage research operations across multiple studies including clinical trials and academic research projects as assigned. Ensure compliance with institutional policies federal regulations (e.g. FDA OHRP) and sponsor requirements. Collaborate with investigators research coordinators regulatory teams and sponsors to streamline project workflows. Implement standard operating procedures (SOPs) and best practices to support consistent and compliant research operations. Serve as a primary point of contact for internal departments and external partners regarding operational matters. Maintain performance metrics and prepare regular progress reports for leadership and stakeholders. Support training and professional development of research staff. Participate in audits inspections and quality improvement initiatives. Coordinate cross-functional activities and manage program logistics. Maintain documentation reporting systems and data tracking to support program evaluation and performance metrics. Serve as a liaison between leadership hospital and faculty departments research administration and external partners. Support the planning and execution of high-level meetings events and collaborative initiatives. Track key initiatives timelines and deliverables to ensure project milestones are met. Assist in the preparation of presentations proposals and reports for internal and external audiences. Partner with the appropriate offices (Office of Clinical and Community Trials (OCCT) and Research Business Operations (RBO) offices) to ensure proper management of program budgets expenditures and financial reporting. Performs job functions adhering to service principles with customer service focus of innovation service excellence and teamwork to provide the highest quality care and service to our patients families co-workers and others. Other job functions as assigned.

Knowledge Skills and Abilities:

Bachelors Degree or equivalent professional experience (three to five years in clinical research) Minimum of three years of work experience involving clinical trials clinical research operations and/or grant/research administration experience in a hospital university or other research setting. Knowledge of research regulations (FDA OHRP GCP etc.) preferred. Good clinical practices documentation required. Strong verbal and written communication skills in order to address large diverse audiences. Ability to work independently and as a member of a team and follow through on assignments with minimal direction required. Solution oriented with proven record of managing large scale research projects with diverse complexity required. Abilityto quickly reason withinformation to solve new unfamiliar problemsorindependent of any prior knowledge. Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines required. Masters degree and/or certification through Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Administrator (CRA)/Certified Financial Research Administrator (CFRA) preferred. Personal computer skills; functional experience with integrated software systems and proficient in Microsoft Office applications.

Education

Pay Range

At Lurie Childrens we are committed to competitive and fair compensation aligned with market rates and internal equity reflecting individual contributions experience and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions.In addition to base salary Lurie Childrens offer a comprehensive rewards package that may include differentials for some hourly employees leadership incentivesfor select roles health and retirement benefits and wellbeing programs. For more details on other compensation consult your recruiter or click the followinglink to learn more about our benefits.

Benefit Statement

For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:

Medical dental and vision insurance

Employer paid group term life and disability

Employer contribution toward Health Savings Account

Flexible Spending Accounts

Paid Time Off (PTO) Paid Holidays and Paid Parental Leave

403(b) with a 5% employer match

Various voluntary benefits:

• Supplemental Life AD&D and Disability

• Critical Illness Accident and Hospital Indemnity coverage

• Tuition assistance

• Student loan servicing and support

• Adoption benefits

• Backup Childcare and Eldercare

• Employee Assistance Program and other specialized behavioral health services and resources for employees and family members

• Discount on services at Lurie Childrens facilities

• Discount purchasing program

Theres a Place for You with Us

At Lurie Childrens we embrace and celebrate building a team with a variety of backgrounds skills and viewpoints recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly appreciate differences and make meaningful connections that foster belonging. This is a place where you can be your best so we can give our best to the patients and families who trust us with their care.

Lurie Childrens and its affiliatesare equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race color sex sexual orientation gender identity or expression religion national origin ancestry age disability marital status pregnancy protected veteran status order of protection status protected genetic information or any other characteristic protected by law.

Support email: