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.

Requirements

High School Diploma/GED, required.
Bachelor's degree in a Science, Sociology, or related field, preferred.
California phlebotomy certification required upon hire.
ACRP/SOCRA certification is preferred.
1 year of clinical research related experience is required.

Benefits

Health insurance
401(k) matching
Flexible working hours
Paid time off
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Case Report Forms (CRFs)Good Clinical Practice (GCP)patient research billingdata quality monitoringprotocol complianceadverse event reportingregulatory compliancebudgeting dutiesclinical research experience

Soft Skills

communicationcollaborationorganizational skillsattention to detailproblem-solving

Certifications

California phlebotomy certificationACRP certificationSOCRA certification