Manages day-to-day study operations under the direction of a Principal Investigator, ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance
Job Summary
Manages day-to-day study operations under the direction of a Principal Investigator, ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance.
Responsibilities include coordinating study start-up, recruiting and consenting participants, planning and conducting study visits, ensuring participant safety, and managing regulatory documentation.
The role requires deep, hands-on expertise in ICH-GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct, with a focus on ethical practices and participant rights.
Matching Summary
Manages day-to-day study operations under the direction of a Principal Investigator, ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance.
Salary
$53,454 + depending on qualifications
Skills & Requirements
Must-have
protocol fidelity
participant safety
data integrity
regulatory compliance
ICH-GCP
IRB/HIPAA
EDC/CTMS
Nice-to-have
interpersonal savvy
decision quality
planning and priority setting
ethics and values
learning agility
Key Requirements
Bachelor's degree or equivalent experience
3 years clinical research coordination experience
Experience with screening/consent, visit coordination, data entry, IRB submissions