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

Salary : $60,000 - $80,000