Clinical Research Coordinator - Clinical Research

CenExel•Riverside, CA

5h•$30 - $34

About The Position

Responsible for assisting with the coordination of clinical trials while adhering to ICH, GCP, study protocols, and company guidelines, regulations, and policies. The coordinator supports patient involvement from study initiation through completion, organizes research information, observes subjects, supports data analysis and reporting, and coordinates data collection. The role also includes documenting adverse events and protocol deviations, maintaining research quality and compliance, and performing study-related administrative and regulatory duties. The coordinator helps ensure the research site receives accurate study information and supplies from sponsors, educates potential participants and caregivers about protocol details and expectations, and performs protocol-required safety and efficacy assessments, including vital signs, EKGs, and blood draws. Other duties may be assigned. The position is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m.; shift work may vary by location. Overnight travel may be required for training or investigative meetings.

Requirements

High school graduate or equivalent.
At least 1 year of experience as a Clinical Research Coordinator.
Knowledge and understanding of federal regulations protecting human subjects in research and governing clinical trials.
Strong leadership and mentorship skills.
Ability to develop and maintain effective working relationships at all levels of the organization and with sponsors and vendors.
Crisis management and problem-solving skills, including the ability to react calmly and effectively in emergent situations.
Ability to work independently and as part of a team.
Effective verbal and written communication skills.
Ability to meet essential physical requirements, including sitting, typing, standing, walking, and occasional lifting of up to 20 pounds; rarely lift over 20 pounds.
Ability to report to work as scheduled.
Willingness to travel overnight for training and/or investigative meetings, as required.

Nice To Haves

Bachelor's degree.

Responsibilities

Assist with coordinating all aspects of patient involvement from study initiation through study completion.
Organize research information for clinical trials.
Observe subjects and assist with data analysis and reporting.
Schedule data collection.
Document adverse events, protocol deviations, and other unanticipated problems appropriately.
Report research data to maintain quality and compliance.
Perform administrative and regulatory duties related to studies as appropriate.
Participate in other protocol development activities.
Ensure the site receives accurate information and supplies from sponsors, including source documents, protocols, scales, supplies, approvals, and contacts.
Educate potential participants and caregivers about protocol-specific details and expectations.
Perform safety and efficacy assessments according to protocol, including vital signs, EKGs, blood draws, and other assigned assessments.
Assume other duties and responsibilities as assigned.