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.
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors for study updates.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.

Requirements

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

Applicant Tracking System Keywords

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

Hard Skills & Tools

data collectiondata entryresearch study assessmentsliterature reviewsprotocol complianceadverse event reportingbudgeting dutiespatient research billingGood Clinical Practice (GCP)HIPAA regulations

Soft Skills

communicationorganizational skillscollaborationattention to detailproblem-solvingtraining coordinationconfidentialitymonitoringauditingtime management

Certifications

High School Diploma/GEDCalifornia phlebotomy certificationACRP certificationSOCRA certification