Clinical Research Coordinator I

Clinical Research Coordinator I

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.

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 include:

• 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.
• Understand 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 include a college or university degree in a related field and less than 2 years of work experience in a related job discipline.

Preferred qualifications include a bachelor's degree, knowledge of medical terminology/environment, and competencies such as 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, and adaptability to changing working situations and work assignments.

Application documents required include a resume and cover letter.