Clinical Research Coordinator

Required Qualifications
Job Description
Experienced Clinical Research Coordinator
Clinical Research Institute has a great opportunity for a Full-Time Clinical Research Coordinator in our downtown Minneapolis, MN office. Clinical Research Institute specializes in Phase I-IV clinical trials for allergy, asthma, migraines, food allergy, vaccines, COPD and atopic dermatitis for all age groups. The Clinical Research Coordinator will oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of study participants while assuring compliance with the trial protocol as well as state and federal regulatory guidelines.

Responsibilities include, but are not limited to:
Manage and assume responsibility of ensuring adherence and proper execution of clinical trial protocol procedures and data collection
Prepare and maintain source documents
Create recruitment plan to identify eligible study participants with Recruitment Specialist(s)
Oversee study-specific regulatory matters with Regulatory Specialist
Conduct study participant visits including informed consent process and protocol-defined procedures
Perform data entry and respond to data queries in a timely manner
Monitor trial participant safety and adverse events; ensure events are reported per sponsor and IRB-guidelines
Maintain research records of study activity, including case report forms, drug dispensation records and other regulatory forms as per FDA guidelines
Manage monitoring visits and audits
Interact with physician investigators, clinical staff and industry sponsors
Periodic overnight travel may be required for attending Investigator Meetings and/or other training events
Qualifications/Experience and Education Requirements:
Minimum of 2 years work experience as a clinical research coordinator (If you do not have this experience your resume will not be considered)
Bachelor's Degree or higher in health-related or life-science field
Ability to understand and implement study protocols with high ethical standards
Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g. FDA, OHRP, GCP/ICH and HIPAA regulations.

Experience conducting informed consent process and adverse event reporting
Project and time management skills to include the ability to adapt to project changes and priorities
Strong verbal and written communication skills and ability to present information and respond to questions from Investigators and study participants
Excellent attention to detail and organizational skills
Self-motivated with the ability to think critically and take initiative
Ability to work independently and as part of a team
Proficiency with medical terminology and ability to work in a PC environment with Microsoft Office products
Preferred Qualifications:
Clinical Research Coordinator certification
Familiarity with Electronic Data Capture (EDC), Interactive Response Technology (IRT) and Clinical Trial Management Systems (CTMS)
Experience with phlebotomy/laboratory processing
Reports to:
Research Manager
What we offer:
Office hours are 7:30am - 4:30pm Monday - Friday
Competitive compensation and benefits, including health insurance, life & long-term disability insurance, 401K with profit sharing, paid holiday, vacation and sick time
Professional support for relevant licensure and CRC certification
Salary determine based on experience
Learn more about us at CRIMinnesota.com
Job Type: Full-time
Job Type: Full-time
Pay: $60,000.00 - $80,000.00 per year
Benefits:
401(k)
401(k) matching
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Retirement plan
Vision insurance
Work Location: In person