JOB SUMMARY:
The Clinical Research Coordinator works independently providing study coordination including
- Coordinate and manage clinical trial activities in compliance with study protocols, ICH-GCP guidelines, FDA regulations, and IRB requirements.
- Recruit, screen, consent, and follow up with study participants
- Conduct informed consents with study participants
- Responsible for oversight of all assigned studies
- Plans and coordinates strategies for increasing research participant enrollment, improving efficiency.
- Schedule and conduct study visits, including data and sample collection.
- Maintain accurate source documentation, regulatory binders, and case report forms.
- Prepare, submit, and maintain regulatory documents for IRB and sponsor submissions.
- Ensure timely reporting of adverse events, deviations, and essential documents.
- Act as a primary point of contact for study monitors, sponsors, and investigators.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.
- Independent study coordination including screening of potential research participants for protocol eligibility.
- presenting non-medical trial concepts and details to the research participants and participating in the informed consent process.
- Scheduling of research participants for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Schedules and participates in monitoring and auditing activities.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May involve other regulatory / Institutional Review Board duties
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
- At least 2 years of clinical research experience; experience in liver studies strongly preferred.
- Perform study procedures, including phlebotomy, vital signs, and specimen processing.
- Current phlebotomy certification and proficiency in blood draws required.
- Strong organizational skills and attention to detail.
- Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
- Excellent communication and interpersonal skills for working with patients, physicians, and sponsors.
- Identifies new research opportunities and presents to investigators.
- Organizes routine research meetings.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Education:
BA/BS degree.
Certification/License:
Phlebotomy Certification
Experience:
Two years minimum of directly related experience.
EDUCATIONAL AND WORK EXPERIENCE PREFERENCES:
PHYSICAL REQUIREMENTS (physical abilities essential to perform the job):
- Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time.
- Able to read papers and online documents. Able to operate standard office equipment.
- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Job Type: Full-time
Pay: $72,000.00 - $78,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
