Temporary Clinical Research Coordinator II

University of Chicago•Chicago, IL

1d•$24 - $36

About The Position

The Section of Urogynecology and Reconstructive Surgery is part of the Department of Obstetrics and Gynecology. The Urogynecology team provides a personalized and integrated patient care experience across 6 fully equipped clinical sites to allow women with pelvic floor disorders world class Urogynecologic care close to their homes. The Section includes 6 board certified Urogynecologic Surgeons and 5 advanced practiced providers who work collaboratively to care for women with pelvic floor disorders. Teaching, research, and the highest quality clinical care are top priorities for the Section. Urogynecology and Reconstructive Pelvic Surgery at UC Medicine offer patients’ participation in innovative clinical research trials. Job Summary: The Temporary Clinical Research Coordinator supports the execution of moderately complex clinical research studies from initiation through close out. This role assists with coordinating study activities, maintaining regulatory compliance, managing study documentation, and facilitating communication across investigators, sponsors, and research teams. The coordinator helps conduct clinical and non clinical research activities, supports participant recruitment and study visits, collects and manages research data, and contributes to study reporting and dissemination efforts. The role operates under the guidance of the study team and adheres to institutional, state, and federal regulations to ensure studies are conducted efficiently, ethically, and in alignment with sponsor requirements.

Requirements

Ability to independently coordinate and manage moderately complex clinical research studies from start up through close out.
Knowledge of IRB processes, regulatory requirements, and institutional, state, and federal research policies.
Strong data management and analytical skills, including experience with REDCap, Excel, and other research data systems.
Understanding of research methodologies and basic laboratory techniques applicable to clinical and non clinical studies.
Sound problem solving skills with the ability to exercise professional judgment in resolving study related operational, compliance, and financial issues.
Effective collaboration and communication skills when working with investigators, sponsors, multidisciplinary teams, and external partners.
Strong organizational skills and attention to detail with the ability to manage multiple studies and competing priorities.
High School Diploma required.
At least two years of related work experience preferred.

Nice To Haves

Bachelor’s degree in research or a related field preferred.
Previous clinical trials experience preferred.
Previous IRB protocol experience preferred.

Responsibilities

Develop study protocols, CRFs, and other study documents.
Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
Collect, archive subjects’ data.
Assist in scientific data dissemination.
Develop, write, edit, submit and publish scientific manuscripts and present scientific abstract at national and international conferences.
Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
This job provides technical and administrative support in a laboratory environment performing basic laboratory techniques, research and analysis under direction.
Provides routine or standardized laboratory duties by collecting data in support of research projects under direct supervision.
Collects and enters data.
Assists in analysis of data and with preparation of reports, manuscripts and other documents.
Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, subject consenting, subject recruitment, perform and supervise various study visit procedures, and participation in program audits.
Prepares program conference lists for multidisciplinary conferences and workshops.
Participates in all pharmaceutical site visits.
Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
Interprets the data needed for insurance submissions.
Gathers pre-testing results if obtained at an outside facility.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Performs other related work as needed.