Clinical Research Operations Manager

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.

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 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.
* 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 (LCH’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.), advertisers, etc. to resolve issues and problems,…