Clinical Research Coordinator - Clinical Research

CenExel•Bellflower, CA

1d•Onsite

About The Position

The Clinical Research Coordinator assists with coordinating clinical trials while adhering to ICH, Good Clinical Practices, study protocols, and company guidelines, regulations, and policies. The role supports patient involvement from study initiation through completion, organizes trial information, schedules data collection, observes participants, and assists with data analysis and reporting. It also includes documenting adverse events, protocol deviations, and other unanticipated problems; maintaining research data quality and compliance; and performing administrative, regulatory, and protocol-development activities. The coordinator helps ensure the site receives accurate study information and supplies from sponsors, educates potential participants and caregivers about protocol requirements, and performs protocol-specific safety and efficacy assessments, including vital signs, EKGs, blood draws, and other assigned assessments. The position is based in an indoor office environment and may involve shift work depending on location, occasional lifting up to 20 pounds, and overnight travel 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 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.

Nice To Haves

Bachelor's degree preferred.

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 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.