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.

Job Description Summary
Based on specific research program needs patient facing vs. data administrative responsibilities will vary. Coordinates all clinical research activities with moderate supervision. Coordinates & completes activities associated with the creation and implementation of participant recruitment strategies designed to enhance enrollment in a single complex large nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research studies involving multiple sites &/or longitudinal assessments/ interventions.

Job Duties:

• Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.
• Prepares protocols informed consent documents modifications renewals and other necessary documents for review by the IRB and/or sponsor.
• Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC SRC etc.) and protocol is followed.
• Identifies and recruits eligible study subjects; conducts informed consent/assent process.
• Arranges and conducts clinical research visits.
• Conducts site qualifications study initiation monitoring and/or close-out visits.
• Attends investigator meetings.
• Abstracts data from medical records and enters medical information/data onto protocol specific case report forms study flow sheets and other required study forms; prepares abstracted/coded data for processing/analysis.
• Creates and/or updates case report forms and/or source document templates and/or data dashboards.
• Coordinates reimbursement of subjects.
• Maintains inventory of supplies/equipment.
• Prepares lab kits and requisitions prior to visits.
• Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly.
• Records data on source documents and CRFs and/or electronic web based systems.
• Conducts literature searches and assists with QA/QC procedures.
• Adheres to research protocol in compliance with applicable institutional local and federal regulations (OHRP FDA GCP etc.).
• Maintains all study documents (regulatory binders source documents correspondence etc.).
• Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning presenting etc.).
• 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.
• QA/QC checks for database validity and data monitoring.
• Tracking deadlines for grants/deliverables.
• Recruitment Focused Tasks:
• Coordinates and guides the creation and implementation of a recruitment & retention plan associated with clinical research Investigator Initiated Sponsored & Outcomes studies involving human subjects ensuring the protection of their safety rights and welfare.
• Determines interprets and applies rules and regulations (LCH local state federal industry sponsor etc.) and recommends and guides principal investigators (PIs) and research staff in the creation submission documenting reporting etc. of study recruitment and enrollment activities ensuring appropriate compliance.
• Acts as liaison between research staff (PI faculty nurses technicians etc.) and internal/external regulatory and oversight groups (LCHs IRB sponsors (NIH industry) government agencies (FDA) etc.) advertisers etc. to resolve issues and problems negotiate compromises and offer alternatives and recommendations to facilitate and expedite study recruitment and enrollment while ensuring compliance.
• Creates research study recruitment materials and execute implementation of marketing materials across multiple platforms (e.g. print digital radio television).
• Designs recruitment screening tools and best practices to support clinical and outcomes research in collaboration with CRPs DAR IM and the IRB. Facilitate script development and feedback sessions with hospital Advisory Boards and community stakeholders.
• Develop and facilitate research protocols related to measuring the use and effectiveness of educational videos and other recruitment materials in the research community.
• Investigator initiated sponsored and externally sponsored both type and sponsor
• (Focus on diversity & minorities) evaluate barriers to increase recruitment of children teenagers and young adults who are underrepresented in bio-medical research
• Assist teams in creation of recruitment plans and materials prior to IRB submissions until study is completed.
• Move regulatory functions to bottom (not enforcement role)
• Other job functions as assigned.

K.S.A.s:

• High School Diploma with three to five years of clinical research experience -or
• Associates /two years of College with two to four years research experience or-
• Bachelors with one to three years research experience.
• Knowledge of research regulations (FDA OHRP GCP etc.) preferred.
• Good clinical practices documentation required.
• Familiarity and experience with FDA and IRB regulatory requirements preferred.
• Clinical Research Experience preferred.

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.

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