Clinical Research Coordinator II

Department
 

BSD OBG - MIGS

About the Department
 

The Department of Obstetrics and Gynecology has 136 clinical providers, providing care at the main hospital in Hyde Park and seven off site locations. We have more than 68,000 outpatient visits, 28,000 ultrasound visits, 2,800 deliveries, and 3,300 surgeries per year. Teaching, research, and the highest quality clinical care are top priorities for the Department. The residency and fellowship programs are highly ranked and have a history of training leaders in healthcare. The Department also has a significant research enterprise, engaging in population health studies, as well as research conducted in wet laboratories on tumor biology, fibroid research, and hypertensive diseases in pregnancy. Additionally, the Section of Family Planning has established a unique research center, CI3, which focuses on reproductive policy and innovations in sexual and reproductive health. The department was ranked #16 on the 2022-2023 U.S. News & World Report.

Job Summary
 

Our research group is looking for a Clinical Research Coordinator II 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.

The job compiles, documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

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.

• 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.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

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

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Work Experience:

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

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Certifications:

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Preferred Qualifications

Education:

• Advanced degree in research or a related field.

Experience:

• Previous clinical trials experience.

• Previous IRB protocol experience.

• Experience in women reproductive health studies.

Preferred Competencies

• Organization.

• Problem-solving.

• Collaboration.

• Attention to detail.

• Ability to work autonomously.

• Proficiency in Microsoft Office, includ