layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Clinical Research Manager, Research Incubation Unit at University of Chicago | LAYIQ

Education: Master's Degree strongly preferred.
Experience: Experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management.
Regulatory support for FDA and IRB filings.
Protocol development support experience.
Licenses and Certifications: ACRP / SOCRA research certification.
Preferred Competencies
Mentors or trains others to communicate effectively with CRO and/or sponsor, and in managing and conducting site visits. Understands the relationship between sites, sponsors and CROs in order to solve problems.
Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol.
Determines and manages complex study and equipment resources for more than one study, and processes related to their management. Forecasts study needs, including staffing. Effectively solves complex problems related to managing resources.
Ensure that multiple studies are conducted in compliance with institutional requirements and other policies. Mentor others in this area.
Develops, follows, and implements detailed complex operational plans for research protocol(s) (those that require coordination of multiple units or services).
Partnering with faculty set site performance metrics and targets: enrollment, retention, data quality, start-up timeline, Unanticipated Problem rate etc. and works with team to understand root cause of metric in non-conformance and take appropriate actions. Measures impact of preventive and corrective actions.
For complicated scenarios, recognizes when all types of agreements (MTAs, CTAs, CDAs, DUAs, DTAs, etc.) are necessary and which procedures to follow, including special terms that may need to be included.
Prepares and maintains FDA regulatory submissions on more than one PI-initiated study overseen by the FDA. Handles complex situations and/or potential hold issues directly with the FDA, in collaboration with the PI.
Demonstrates advanced application and knowledge of monitoring and audits. Trains or leads others in most tasks related to monitoring and audits.
Sets meeting objectives, goals and detailed agendas for multidisciplinary meetings. Mentors or trains others in meeting preparation and follow up. Facilitate healthy communication during meetings.
Conduct and document informed consent for multiple interventional and/or complex studies. Exhibit additional knowledge or skills in consent procedures.
Advanced understanding of sponsor/regulatory reporting.
Independently develops, or guides the development, of multiple complex data entry or collection protocols and tools. Systems are developed to ensure quality of data. Trains others in collecting and entering data.
Working Conditions
Office Environment (ADA compliant).
Clinical care units where research is conducted, and department lab space for specimen processing.
Application Documents
Resume (required)
Cover Letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Research
Role Impact
People Manager
Scheduled Weekly Hours
40
Drug Test Required
No
Health Screen Required
No
Motor Vehicle Record Inquiry Required
No
Pay Rate Type

Clinical Research Manager, Research Incubation Unit

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