Clinical Research Coordinator 1 - Rheumatology

Job Summary

The Clinical Research Coordinator 1 provides support to Principal Investigator faculty of the Section of Rheumatology within the Biological Sciences Division under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC1 works with the PI, department, sponsor, and institution to support, facilitate and coordinate the daily clinical trial activities and administration of the compliance, financial, personnel and other related aspects of the clinical study.

Responsibilities

• Coordinates all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Coordinates clinical research activities for patients seen within Rheumatology and/or with rheumatic or autoimmune disease diagnoses, including but not limited to: Lupus, Rheumatoid arthritis, Myositis, Scleroderma, Rheumatic toxicities of immunotherapy, etc.
• 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.
• Recruits and interviews potential study patients.
• May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.
• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• 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: ---

Preferred Qualifications

Experience: Clinical research experience or relevant experience. Technical Skills or Knowledge: Knowledge of medical terminology/environment. Knowledge of Microsoft Word, Excel and Adobe Acrobat. Knowledge of complex documents, such as clinical trials. Familiarity with Redcap and Oncore. Familiarity with EPIC.

Preferred Competencies

• Interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
• 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.
• Handle competing demands with diplomacy and enthusiasm.
• Absorb large amounts of information quickly.
• Adapt to changing working situations and work assignments.