Clinical Research Coordinator II

About The Department

Department
BSD OBG - Uro

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 practice 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 job compiles, documents, analyzes, and reports on moderately complex clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University. Our research group is looking for a Clinical Research Coordinator to join its team. Specifically, the Clinical Research Coordinator II will be responsible for all aspects of research projects and research facilities.

Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.

• 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.
• Accountable for all tasks in moderately complex clinical studies.
• 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.

Minimum Qualifications
Minimum requirements include a college or university degree in related field.

Work Experience
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Education
Advanced degree in research or a related field.

• Previous clinical trials experience.
• Previous IRB protocol experience.

• Organization.
• Problem-solving.
• Collaboration.
• Attention to detail.
• Ability to work autonomously.
• Proficiency in Microsoft Office, including Outlook, Excel, Word, PowerPoint.
• Basic Computer Proficiency.
• Knowledge in Relevant Scientific Field.
• Knowledge of Research Techniques or Methods.
• Knowledge of Regulatory Policies and Procedures.
• Analytical Skills.

• Outpatient clinical environment (primarily) and lab environment.
• Ability to travel to multiple clinical sites.
• Ability to stand for extended periods.
• Ability to use computer for extended periods.

• Resume (required)
• Cover Letter…