Experienced Clinical Research Coordinator

Overview

EXPERIENCED Clinical Research Coordinator - Onsite

Job Details:

• 15-20 hours/week for the first 3 months. Potential to increase to 25 hours to 40 hours after 6 months based on the start date of new studies and enrollment in current studies.
• This job is onsite in Los Angeles.
• Remote work is NOT available for this position.

Position Overview:

• The Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) seeks an enthusiastic Clinical Research Coordinator (CRC) to join our dynamic clinical trials team.
• The CRC will plan, coordinate, and manage all activities associated with the initiation, conduct and completion of assigned clinical trials.
• The CRC supports multiple Phase II-IV clinical trials across a variety of disciplines and investigators which may be sponsored by federal agencies including NIH or DOD and pharmaceutical sponsors or CRO’s.
• The CRC maintains compliance with all regulatory bodies associated with human subject research.

• Works collaboratively with Principal Investigator and clinical staff to identify eligible participants for clinical trials.
• Educates patients and their families to assure that they are informed prior to obtaining written consent.
• Educates affected hospital personnel on the details of the trial(s).
• When required, administer and document informed consent prior to initiation of any study-related activities.
• Prepare patient information for registration/randomization.
• Responsible for follow-up and active patient monitoring per study protocol.
• Obtain/coordinate, process and ship subject blood, cultures, tissues, and other specimens for laboratory analysis as described in the study protocol(s).
• Maintain accurate records of subject drug accountability and assist the Investigational Drug Service (IDS) with the receipt, inventory, and dispensation of study drugs and materials as necessary. Work with the clinical staff to administer study drugs to research subjects when applicable.
• Inspect CRFs, source documentation, and study files to ensure completeness.
• Review CRFs, source documentation, and study files with representatives from the sponsor, Clinical Research Organization (CRO), or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs and submit requested documentation in a timely manner.
• Responsible for obtaining required specimens per the protocol and transport of said specimens to the research office for processing and shipment.
• Comply with standard operating procedures of the sponsor, institutional review board (IRB), and CRO involved with the trial.
• Collects, maintains, and stores all relevant clinical data and case report forms, in accordance with the study sponsor and all regulatory bodies.
• Collects pertinent information and data from subject charts and records, subject interviews, and other sources, while maintaining the highest standards in the protection of VA sensitive information. Create and complete case report forms (CRFs) in accordance with research protocol guidelines.
• Collaborate closely with the investigator and clinic staff in scheduling future appointments and explaining patient questionnaires.
• Update the project Clinical Trials Management system and the GLAVREF CTMS in a timely manner, which includes but is not limited to subject enrollment, patient payments and study milestones.
• Schedule and attend all Site Initiation Visits, Monitoring Visits, Close-Out Visits etc. for all assigned studies/or when asked to attend by the Lead Clinical Coordinator.
• Responsible for preparing the research chart for internal audits.
• Responsible for obtaining required specimens per the protocol and transport of said specimens to the research office for processing and shipment.
• Responsible for evaluation and reporting serious adverse events and expedited reporting of such events if required.
• Responsible for ensuring protocol adherence by understanding, communicating, and making sure the study parameters are ordered and carried out per protocol requirements.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
• Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Report any evidence of research non-compliance in a timely fashion.
• Provides cross-coverage for trials as assigned.
• Presents information at regular research staff meetings.
• Present information and respond to questions from physicians, staff, and patients.
• Obtain all required source documentation.
• Minimal travel is required, CRC will attend management-approved educational conferences and study meetings when available.
• May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities.
• Maintain accurate and timely documentation (e.g. assessments and participant notes using REDCap).
• Ensures…