Clinical Research Coordinator

Are you seeking employment where you make a difference and be challenged? A job that has potential for growth, where you can continue to learn new ideas? Consider a job in Clinical Research. Montana Medical Research, Inc has openings for a Clinical Research Coordinator.

Job description

Full Job Description

The Research Coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

Essential Responsibilities and Duties:

• Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and monitoring while the subjects are on study
• Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports
• Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications
• Schedule subjects in protocol defined windows
• Go through the consent form with patients and ensure that they understand and sign ICF prior to any study related procedures.
• Perform ratings scales that you have been trained on
• Communicate with sponsors and CROs and reviews and responds to any monitoring findings and escalates issues
• Make IRB submissions in collaboration with the regulatory coordinator (Continuing reviews, SAEs, protocol deviations, and other when required) and maintain IRB binder
• Resolve queries in a timely manner and be capable of entering data into the EDC if assistant is not available to do so
• Communicate with PI regarding trial requirements, safety evaluations, regulatory, and monitoring
• Ensure that the PI signs off on labs, AEs, and ECGs in a timely manner
• Ensure all regulatory binders are up to date
• Recruit patients via research database, ad campaigns, and MD-MD letters
• Phlebotomy and ECGs
• Understand disease states
• Dispense IP and perform accountability
• Communicate with vendors
• Communicate with patients and caregivers

Qualifications

• Bachelors degree in a life science or At least 2 years of relevant work-related experience in the medical field
• CCRC certification not required, but preferred
• Knowledge of “good clinical practices” for clinical research as defined by the Code of Federal Regulations (CFR). Preferred but not required
• Demonstrate organizational skills to efficiently and effectively manage multiple clinical trials while providing accurate information in a timely manner.
• Communicate and work effectively with a diverse team of professionals
• Phlebotomy and ECGs experience not required, but preferred
• Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
• Must be self-directed and be able to manage multiple projects and responsibilities.
• A critical thinker with strong attention to detail and superb problem-solving abilities.
• currently reside in geographical location or have housing arranged

Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job Type: Full-time

Benefits:

• Retirement
• Employee assistance program
• Health insurance
• Paid time off

Job Type: Full-time

Job Type: Full-time

Pay: $20.00 - $28.40 per hour

Benefits:

• 401(k)
• Flexible schedule
• Health insurance
• Paid time off

Work Location: In person