Title: Clinical Research Coordinator 

Location: La Mesa, CA

Salary Range: $25- $30 per hour (Based on experience)

Duties and Responsibilities:

• Possesses detailed knowledge of applicable protocols to ensure completion of all clinical trial activities correctly.
• Maintains an ongoing understanding of the disease state under investigation.
• Responsible for screening, consenting, and enrollment of recruited potential participants.
• Performs comprehensive medical history and collects data according to protocol specifics.
• Performs specific protocol procedures such as taking vital signs, and performing electrocardiograms, etc.
• Randomizes participants per sponsor protocol
• Coordinates timing and schedule of subject visits throughout duration of trial.
• Provides detailed instruction and education to subjects to ensure protocol compliance.
• Distributes test articles as necessary and maintains investigational product accountability records per sponsor and procedures.
• Responsible for upholding federally-mandated guidelines to monitor and protect the safety and welfare of all study subjects.
• Upholds all practices of informed consent and good clinical practice.
• Documents, notifies, and reports to appropriate personnel and agencies any adverse events and serious adverse events promptly and per specifications.
• Submits to the Institutional Review Board continuing review reports, modifications, and close-out reports.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Interacts with physicians, recruitment team, for efficient recruitment and retention of potential participants.
• Serves as a liaison between sponsors, investigators, and subjects.
• Provides the sponsor with accurate and complete documentation following GDP guidelines in a legible and timely fashion.
• Retains documents in a manner defined by sponsor and IRB standards.
• Assists in the training of new staff members.
• Completes study logs and daily client visit logs in an accurate and timely manner.
• Performs GCP training and other sponsor training as required
• Communicate with laboratories or investigators regarding laboratory findings
• Direct the requisition, collection, labeling, storage, or shipment of specimens
• Organize space for study equipment and supplies.
• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Dispense medical devices or drugs and provide instructions as necessary.
• Contact outside health care providers and communicate with subjects to obtain follow-up information.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with investigators
• Schedule subjects for appointments, procedures as required by study protocols.