Job description

The Clinical Research Coordinator II (CRC) is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability with minimal oversight. This is an independent contractor (1099) position.

RESPONSIBILITIES:

• Responsible for the coordination of observational and clinical research trials assigned in the area of rheumatology
• Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
• Informed Consent
• Obtaining patient medical history and medication lists
• Phlebotomy and basic laboratory tests
• Processing & shipping labs for central and local labs
• Patient education and training
• ECG
• Administer questionnaires and assessments
• Vital signs
• Collect information for adverse event reporting
• Assist with joint counts and other efficacy assessments
• Data Entry and Query Resolution
• Study drug administration, including injections
• Tracking study supply inventory and reordering when necessary
• Schedule patient visits in appropriate electronic systems
• Documenting all patient visits and communications in progress notes
• Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
• Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
• Responsible for chain of custody and accurate accountability of investigation product and devices.
• Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
• Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
• Serves as a liaison to all physicians, employees, and third party vendors.
• Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
• Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
• Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment.
• Maintaining office supply inventory while keeping an organized office space.
• Travel as necessary for Investigator Meetings and other sites.

Minimum Qualifications:

Associates Degree

• 1 year experience as a clinical research coordinator
• Individual must have or be working towards obtaining Clinical Research Coordinator Certification (CRCC).
• Must have in-depth knowledge of medical procedures and clinical terminology
• Possess strong organizational skills
• Ability to develop and maintain strong professional relationships with all providers and research subjects
• Maintains confidentiality of patient and study information
• Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations
• Understands and supports specific State regulations governing clinical research
• Excellent verbal and written communication skills
• Ability to lift 20 pounds
• Willing and able to travel for Investigator Meetings and other sites

Job Types: Part-time, Contract

Schedule:

• Day shift

Ability to commute/relocate:

• Kansas City, MO 64151: Reliably commute or planning to relocate before starting work (Required)

Education:

• Associate (Required)

Experience:

• Clinical research: 1 year (Required)

Work Location: One location

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