Clinical Research Coordinator - Clinical Research

CenExel•Riverside, CA

About The Position

The Clinical Research Coordinator assists with coordinating clinical trials in strict adherence to ICH, GCP, study protocols, and company guidelines, regulations, and policies. The role supports patient involvement from study initiation through completion, organizes research information, observes subjects, assists with data analysis and reporting, and schedules data collection. It also documents adverse events, protocol deviations, and other unanticipated problems; reports research data to support quality and compliance; and performs appropriate administrative and regulatory duties and other protocol development activities. The coordinator ensures the site receives accurate information and supplies from sponsors, educates potential participants and caregivers about protocol-specific details and expectations, and performs protocol-required safety and efficacy assessments such as vital signs, EKGs, blood draws, and other assigned assessments. Other duties may be assigned. The position is based in an indoor office environment and may involve shift work depending on location and overnight travel for training or investigative meetings. The stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m.

Requirements

High school graduation 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 report to work as scheduled.
Ability to meet the physical requirements of sitting, typing, standing, and walking; occasional lifting of up to 20 pounds and rare lifting over 20 pounds.
Ability to travel overnight when required for training and/or investigative meetings.

Nice To Haves

Bachelor's degree.

Responsibilities

Assist with coordinating all aspects of patient involvement from study initiation until study completion.
Organize research information for clinical trials.
Observe subjects and assist with data analysis and reporting.
Schedule the collection of data.
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 the study as appropriate.
Participate in other protocol development activities.
Ensure the site receives accurate information and supplies from sponsors, including source materials, protocols, scales, supplies, approvals, and contacts.
Educate potential participants and caregivers on protocol-specific details and expectations.
Perform safety and efficacy assessments per protocol, including vital signs, EKGs, blood draws, and other assigned assessments.
Assume other duties and responsibilities as assigned.