Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
Schedules and participates in monitoring and auditing activities.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.
May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Coordinates training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Maintains accurate source documents related to all research procedures.

Requirements

High School Diploma/GED, required.
Bachelor's degree in a Science, Sociology, or related field, preferred.
ACRP/SOCRA certification is preferred.
2 years of clinical research related experience, required.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

Case Report Forms (CRFs)Good Clinical Practice (GCP)data quality assessmentprotocol complianceadverse event reportingbudgeting dutiespatient research billingsource document maintenanceauditingStandard Operating Procedure development

Soft Skills

communicationcollaborationorganizationalattention to detailproblem-solvingtraining coordinationquality improvementconfidentiality maintenancesupervisory notificationeducational program participation

Certifications

ACRP certificationSOCRA certification