Clinical Research Coordinator - Clinical Research

CenExel•Los Alamitos, CA

17h•Onsite

About The Position

The Clinical Research Coordinator assists with coordinating clinical trials in accordance with ICH, Good Clinical Practices, study protocols, and company guidelines, regulations, and policies. The role coordinates patient involvement from study initiation through study completion, organizes trial information, observes subjects, assists with data analysis and reporting, schedules data collection, documents adverse events and protocol deviations, and performs related administrative and regulatory duties. The coordinator also helps with protocol development, ensures the site receives accurate study information and supplies from sponsors, and educates potential participants and caregivers about protocol requirements and expectations. Safety and efficacy assessments may include vital signs, EKGs, blood draws, and other protocol-assigned assessments. Other duties may be assigned. This is an indoor, office-environment position. Work is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m., though shift work may depend on location. Overnight travel may be required for training or investigative meetings. The position involves sitting, typing, standing, and walking, with occasional lifting of up to 20 pounds and rare lifting over 20 pounds. Reporting to work as scheduled is essential.

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 throughout 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 the position's physical requirements: sitting, typing, standing, walking, and occasional lifting up to 20 pounds; rarely lifting over 20 pounds.
Ability to report to work as scheduled.
Ability to travel overnight when required for training or investigative meetings.

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 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 studies 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.