Clinical Research Coordinator 1

Department

BSD MED - Nephrology - Chapman Research Staff

About the Department

The Section of Nephrology in the Department of Medicine is comprised of twenty-two faculty members, one PhD scientist, and ten postdoctoral fellows in training devoted to a mission of excellence in patient care, education and research. The Section carries out a range of translational and clinical research in the areas of hereditary kidney diseases, nephrolithiasis, race-specific differences in cation handling by the kidney, acute kidney injury, nutrition, and ESRD related issues including dialysis access and health disparities. Our basic science research portfolio includes investigations into acute kidney injury, epithelial oxalate transport and the microbiome, renal tubular transport defects and studies of amino acid metabolism in renal epithelia.

Job Summary

The Clinical Research Coordinator 1 provides support to the clinical Principal Investigator (PI) Arlene Chapman, MD, in the Section of Nephrology within the Biological Sciences Division. The CRC1 works with the PI, co-clinical research coordinators and sponsoring agencies.

Responsibilities

• Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

• Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Prepares and maintains protocol submissions and revisions.

• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.

• Performs assessments at visits and monitors for adverse events.

• Organizes and attends site visits from sponsors and other relevant study meetings.

• May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Performs other related work as needed.

• Accountable for all tasks in basic clinical studies.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

• Performs other related work as needed.

Minimum Qualifications

Education:

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

Work Experience:

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

Certifications:

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Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• Knowledge of medical terminology/environment.

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

• Ability to communicate with tact and diplomacy.

• Strong organizational skills.

• Strong communication skills (verbal and written).

• Excellent interpersonal skills.

• Strong data management skills and attention to detail.

• Knowledge of Microsoft Word, Excel and Adobe Acrobat.

• Ability to understand complex documents (e.g., clinical trials).

• Ability to handle competing demands with diplomacy and enthusiasm.

• Ability to absorb large amounts of information quickly.

• Adaptability to changing working situati