Clinical Research Coordinator

Purpose: A San Diego clinical research site in National City is seeking a Sr. level clinical research coordinator to join their growing organization.

-Coordinate clinical research trials with safety and efficiency.
-Coordinate Phase I-IV trials from initial Sponsor contact for site selection, study preparation and execution to study completion and close-out.
-Ensure adherence to GCP, FDA Regulations and SOPs.
-Extrapolate patient data and transcribe onto medical forms.
-Collect data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
-Identify problems and inconsistencies and monitor patient?s progress to include documentation and reporting of adverse events.
-Adhere to study protocol.
-Manage patient recruitment and enrollment.
-Ensure that queries are resolved in an accurate and timely manner.

JOB TASKS

-Consult with study participants on purpose of study and obtain informed consent.
Schedule patients for study procedures.
-Initiates and coordinate drug orders.
-Collect, code and evaluate data and prepare appropriate documentation.
-Evaluate feasibility and design of protocols.
-Discuss protocol and potential concerns with PI and monitors.
-Organize and participate in pre-qualification site visit.
-Prepare and submit regulatory documents for Sponsor.
-Educate all staff members regarding study design and time lines.
-Prepare and place advertisements.
-Present information to health care professionals and the community to educate them about current research activities.
-Monitor enrollment goals and modify recruitment strategies as necessary.
-Ensure timely and accurate transcription of data from the source document to the subject CRFs.

QUALIFICATIONS

-2+ years of clinical research experience.
-Certified clinical research coordinators preferred.

For immediate consideration please send resumes to Simone Ando at