Clinical Research Operations Manager

Lurie Children's Hospital•Chicago, IL

About The Position

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 Ann & Robert H. Lurie Children's Hospital of Chicago Job Description 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.

Requirements

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.

Responsibilities

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 CRF’s 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.
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 (LCH’s 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 CRP’s, 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.
Other job functions as assigned.

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