Clinical Research Coordinator I

Department

BSD MED - Pulmonary - Wolfe Research Staff

About the Department

The Section of Pulmonary/Critical Care has been a model of exemplary patient care, research and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72 have devoted themselves to the pursuit of excellence in each of these important activities.

The MICU Research Program, with Dr. Krysta Wolfe is looking for a dedicated research coordinator to aid with the development/maintenance of datasets and data collection for a variety of projects related to the care of patients in the intensive care unit.

Job Summary

The Clinical Research Coordinator I (CRC I) provides support to the faculty of the Section of Pulmonary/Critical Care within the Department of Medicine. The CRC I works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

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

• Maintain 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.

• Perform specific protocol procedures (specimens and data management, survey/questionnaire administration and the like) required to conduct the study and retain research subjects.

• Understands protocols and may collect information about adverse events (AEs), identified in the protocol or investigator brochure.

• Plan and coordinate patient schedule for study procedures, return visits, and study treatment schedules.

• Ensure Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• Prepare and maintains protocol submissions and revisions.

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

• ​Perform assessments at visits and monitors for adverse events.

• Organize and attend 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 participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• 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 situations and work assignments.

Application Documents

• Resume (required)

• Cover Letter (required)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Applic