Clinical Research Start Up Specialist

Lurie Children's; Chicago (IL); Hybrid; USD 66,000 - 107,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

403(b) with 5% match

Paid time off

Parental leave

Flexible Spending Accounts

Job summary

Ann & Robert H. Lurie Children's Hospital of Chicago seeks a Clinical Research Start Up Specialist to streamline study intake from CDA through Epic RSH setup. You will coordinate with PI, sponsors and departments, review protocols and ensure proper CTMS data and timelines are in place.

The role requires a Bachelor's degree or 3+ years in clinical research, strong communication, and ability to manage high volumes with attention to detail. Competitive salary and comprehensive benefits are offered.

Qualifications

• Bachelor's degree or 3+ years of relevant experience.
• Understanding of coverage analysis, study budgets, informed consent forms, CTA cost language.
• Strong communication, organization and data management skills.

Responsibilities

• Supports rapid study start up workflows and intake for feasibility to contract.
• Coordinates with PI, study teams and Finance to meet deadlines and budgets.
• Reviews documents to ensure required information and routing to proper teams.
• Tracks dates/status in CTMS and ensures data entry in study systems.
• Collaborates with investigators and vendors to meet internal and external needs.
• Maintains confidentiality and ensures billing compliance and accurate documentation.

Skills

Project coordination

Communication

Attention to detail

Microsoft Office

CTMS proficiency

Epic RSH

Education

Bachelor's degree or 3+ years experience

Tools

CTMS

Epic

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****General Summary:**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.**Education****Pay Range**$65,520.00-$107,120.00 SalaryAt 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 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 insuranceEmployer paid group term life and disabilityEmployer contribution toward Health Savings AccountFlexible Spending AccountsPaid Time Off (PTO), Paid Holidays and Paid Parental Leave403(b) with a 5% employer matchVarious 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 Children's 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:**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