Clinical Research Start Up Specialist

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 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.

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 Children's facilities
• Discount purchasing program