Clinical Research Start Up Specialist

Ann & Robert H. Lurie Children's Hospital of Chicago; North Chicago (IL); On-site; USD 66,000 - 107,000; Full time

Job summary

Ann & Robert H. Lurie Children’s Hospital of Chicago is seeking a Clinical Research Start Up Specialist to support startup workflows, feasibility assessments, and budget coordination across sponsors, CROs, and study teams.

You will manage documents, review intake submissions, and ensure Epic RSH setup aligns with protocol requirements while tracking milestones in CTMS. Collaboration with Finance, Investigators, and ancillary services is essential.

Qualifications

• Bachelor’s Degree or three+ years of relevant experience.
• One to two years experience in clinical research conduct, regulatory compliance, billing, and/or budget management preferred.
• Ability to interpret cost language in CTA and budget; interpret protocol information.
• Strong understanding of research billing compliance preferred.
• One to two years in healthcare finance preferred.
• Proficient with integrated software systems and MS Office.

Responsibilities

• Supports rapid study start up workflows and intake of new clinical research studies.
• Coordinates with Research Operations, Finance, and Sponsors to ensure smooth feasibility to contract processes.
• Assists PI and study staff in feasibility and startup activities.
• Reviews submissions to ensure complete information and proper routing.
• Tracks dates and statuses in CTMS and related systems.
• Collaborates with investigators, study teams, and vendors to meet internal and external deadlines.
• Ensures processes are applied for protocol amendments with fiscal impact.

Skills

Clinical Research

Budgeting

Regulatory Compliance

Microsoft Office

Communication

Education

Bachelor’s Degree or 3+ years experience

Tools

CTMS

Epic

Microsoft Office

Job description

Ann & Robert H. Lurie Children’s 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 Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

Location

Simpson Querrey Biomedical Research Center

Job Description

The Clinical Research Start Up Specialist is an integral member of the Office of Clinical and Community Trials (OCCT). Under the direction of the Director, ROC, the Start Up Specialist is responsible for working together with the Clinical Research Operations Managers, Research Technology Administrator, Sponsors/CROs, Principal Investigators, study teams and ancillary services to provide a smooth and efficient intake process. The Start Up Specialist will assist in shepherding studies from CDA through Epic RSH set-up including managing study documents, reviewing intake submissions, supporting workflows in the clinical trial management system (CTMS) and confirming appropriate details are added to Epic.

Essential Job Functions

• Supports rapid study start up workflows and the intake of all new clinical research studies to initiate the process for financial and administrative viability review.
• Works closely with all members of Research Operations and Conduct, Clinical Research Support Services, and Clinical Research Finance service lines to assure a smooth process from feasibility to final contract execution for varying funding types.
• Works closely with the Principal Investigator and study staff in coordinating activities and follow-up associated with determining the feasibility of potential new clinical research studies.
• Reviews submitted documents to ensure they contain necessary information and are routed to the proper teams. For example, reviewing a protocol to determine if it has clinical procedure that would require lab or MIRO involvement.
• Works within the research technologies, including the CTMS, to tracks dates and statuses throughout start up and confirms dates are entered in the research systems.
• Collaborates with Investigators, study teams, appropriate internal departments, and 3rd party vendors through the startup process to ensure internal and external deadlines are met as well as the needs of the Institution and external funding agencies.
• Communicates with study teams, divisions, ancillary services, appropriate internal departments such as Finance, and 3rd party vendors on the centralized start up process and standardization strategies and processes.
• Ensures that all applicable processes are applied for subsequent protocol amendments with financial and/or billing compliance impact.
• Performs job functions and assigned duties 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

• Bachelor’s Degree or three+ years of relevant experience
• One to two years experience in clinical research conduct, clinical research regulatory compliance, clinical research billing, and/or clinical research/trial budget and contract management preferred. Understanding of coverage analysis, study budgets, informed consent forms, and CTA cost language preferred.
• Ability to interpret cost language present in the CTA and budget required. Ability to interpret research protocol information essential.
• Strong understanding of research billing compliance preferred.
• One to two years of work experience in healthcare finance (patient billing, collections, account reconciliations, etc) preferred.
• Working knowledge of medical terminology preferred.
• Ability to work independently and as a member of a team and follow through on assignments with minimal direction required.
• Demonstrated accuracy and precision, attention to detail, and exceptional organizational skills essential.
• Strong verbal and written communication skills required.
• Ability to manage large quantities of data in a manner which facilitates sharing of information
• Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines required.
• Ability to prepare accurate documentation of events required. Ability to maintain confidential material and information required.
• Personal computer skills; functional experience with integrated software systems and proficient in Microsoft Office applications.

Pay Range

$65,520.00-$107,120.00 Salary
At Lurie Children’s, 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 Children’s offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits.

Benefits

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 Children’s facilities
• Discount purchasing program

There’s a Place for You with Us

At Ann & Robert H. Lurie Hospital of Chicago and its affiliates (collectively “Lurie Children’s”), we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints — recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. 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 Children’s and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. 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.
For questions about how to request an accommodation please contact: [e-mail]

AI Notice

Lurie Children’s utilizes certain AI-enabled features within our recruiting platform to support candidate engagement and assist recruiters in identifying and prioritizing applicants whose experience aligns with job requirements. All employment decisions are made by individuals.
It is a civil rights violation with respect to recruitment, hiring, promotion, or employment for an employer to use artificial intelligence that has the effect of subjecting employees to discrimination on the basis of protected classes under the Illinois Human Rights Act or to use zip codes as a proxy for protected classes.
For questions about the use of artificial intelligence in this process or any additional support, please contact: [e-mail]