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Form of workJob Description
JOB SUMMARY
The Regulatory and Study Coordinator is responsible for recruiting, managing and conducting clinical research studies that test the effectiveness of new drugs.
Duties and Responsibilities
Assist in recruitment of study participant and be the point of contact for study participants.
Assist in the creation of recruitment materials, such as newspaper articles, social media advertisements, and online surveys.
Contact potential participants and perform pre-screening to determine their eligibility to join the trial.
Book participants for screening visit at research site and schedule all necessary appointments with the participants.
Manage regulatory activities for all stages of the clinical trial according to the study protocol.
Facilitate and/or conduct the informed consent process in partnership with the principal investigator.
Perform, collect, maintain and document delegated study procedures, ethically conducted, following the protocol and regulatory requirements (i.e. records of study activities, drug dispensation or other regulatory forms as per FDA guidelines).
Schedule participants study visits.
Collect, process, label, and store or ship all specimens.
Dispense trial medication.
Accompany study participants to their physical appointment to record vital signs, and to take pathology samples such as blood and EKGs/ECG's.
Create study specific data collection forms and maintain essential documents in the study site file.
Administer participant questionnaires for data collection.
Prepare and submit regulatory documents and ethical submissions to Sponsor and IRB and works with clinical research team to ensure submission documents are up to date.
Ensure the safety of the participants and the integrity of the data collected.
Ensure all equipment and supplies needed for the study are in-stock and in good working order.
Schedule and manage monitoring visits with auditors, sponsors and/or their representatives.
Complete data entry procedures including entering the collected info into the ehr system and other platforms or websites required.
Ensure compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA).
Maintain compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.
Acquire all necessary certifications through required trainnings.
Other duties as assigned.
SKILLS & REQUIREMENTS
