Full Time,Varies,8 Hour Shift
Job Objective: A brief overview of the position. The position
will be responsible for assisting in the running of Clinical Trials
in the Oncology field.
Reports to Director, Research Administration
Ages of Patients Adult
Blood Borne Pathogens High potential
Qualifications Education Required: BA/BS Degree or in lieu 2-3
Preferred: Degree in Clinical Research, Nursing or
Licensure/Certification Required: California LVN license and
SOCRA or ACRP certification upon eligibility
Preferred: ACRP or SOCRA certification
Experience Required: 1-2 years experience in the Healthcare
Preferred: 2 years in research, some experience in Oncology
Essential Responsibilities Demonstrates compliance with Code of
Conduct and compliance policies, and takes action to resolve
compliance questions or concerns and report suspected
Complete clinical trial feasibility questionnaires.
Work with in-house general counsel and sponsor on Clinical Trial
Work with finance to develop budget for clinical trial.
Recruit, screen, and consent patients for study.
Coordinate completion of pre and post-registration/randomization
tests and exams.
Obtain, prepare (centrifuge) and ship biological specimens.
Document and report adverse events.
Schedule and monitor patient study visits per study
Ensure source documents are complete in order to complete Case
Report Forms (CRFs).
Enter data into sponsor’s electronic data capture (EDC); monitor
data and respond to queries.
Coordinate, prepare for and participate in monitoring visits and
audits. Have regulatory and patient study files in a continuous
state of readiness for audit.
Order study supplies and investigation agents as needed.
Coordinate investigational drug accountability with
Administer, dispense investigational agent.
Interact with physicians, study sponsor, IRB and clinic
Complete paperwork for initial protocol review and submission to
Prepare and submit IRB forms for amendments, non-local adverse
events, annual review.
Maintain investigator files, regulatory files and patient study
Create and track invoices during study.
Track study budget and payments.
Schedule meetings with physicians, create agendas, and take
Send letters and/or telephone patients and physicians regarding
Perform other duties as assigned.