Clinical Research Coordinator (CRC)

Job Description

Job Description

Date posted :  December 20, 2023

Pay :  $60,000.00 - $80,000.00 per year

Job description : Job Description

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 :

Required Qualifications :

Bachelor's Degree or higher in health-related or life-science field

Minimum of 2 years work experience in clinical trials

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 range is determined based on experience and qualifications

Learn more about us at CRIMinnesota.com

Job Type : Full-time

Job Type : Full-time

Benefits :

401(k)

401(k) matching

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Retirement plan

Vision insurance

Schedule :

Monday to Friday

Ability to commute / relocate :

Minneapolis, MN 55402 : Reliably commute or planning to relocate before starting work (Required)

Work Location : In person