Start the day excited to make a difference...end the day knowing you did. Come join our team.

Essential Functions & Responsibilities:

• Performs protocol duties; screening potential research volunteers, vital signs, ECG collection, laboratory sample collection/processing data collection and electronic data entry, as needed.
• Provides guidance to research staff and physician researchers in the interpretation of applicable regulations and guidelines to include, but not limited to GCP, ICH and FDA guidelines.
• Preforms data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
• Maintains all regulatory documents and ensures all protocols and essential regulatory documents are complete, current, and compliant with Good Clinical Practice guidelines, state, and federal agencies.
• Prepares, submits, and maintains IRB, FDA and/or other regulatory documents and research correspondence.
• Prepares adverse event and serious adverse event reports to the IRB, sponsor/CRO, and other agencies (such as FDA).
• Submits SUSAR reports to the IRB, if they meet IRB reporting requirements.
• Prepares and submits protocol deviation reports and protocol exemption requests to the IRB Works directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with state and federal guidelines.
• Ensures compliance with all federal and state agencies including the FDA and MWH Institutional Review Board.
• Prepares invoices for study sponsors, manages receivables, and collection of outstanding revenue and reconciles financial statements.
• Perform other duties as assigned.

Qualifications:

• Phlebotomy and general clinic assessment skills (vital signs and EKG) required.
• Minimum of one year of clinical research experience required.
• One of the following degrees is preferred: 1) Bachelor's degree in health-related field 2) Allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or 3) Associate degree in Clinical Trials Research related curriculum.
• Certified Clinical Research Coordinator preferred.
• Outstanding technical writing skills and understanding of medical terminology/research.
• Exceptional organizational, interpersonal, and presentation skills.
• Ability to: a) understand and follow complex, detailed technical instructions; b) foster a cooperative work. environment; c) maintain quality, safety, and/or infection control standards; and d) understand and follow. basic scientific research protocol and procedure.
• Highly proficient with MS Office (Word, Excel, Access, and PowerPoint), email, internet.

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, sexual orientation, gender identity, national origin, and veteran or disability status.