Clinical Research Coordinator

CenExel•Cherry Hills Village, CO

4d•$28 - $35

About The Position

The Clinical Research Coordinator assists with coordinating clinical trials while adhering to ICH, GCP, study protocols, and company guidelines, regulations, and policies. The role supports patient involvement throughout a study, organizes trial information, schedules data collection, observes participants, and assists with data analysis and reporting. It also documents adverse events, protocol deviations, and other unanticipated problems, and reports research data to support quality and compliance. The coordinator performs study-related administrative and regulatory duties, contributes to protocol development activities, and helps ensure the site receives accurate information and supplies from sponsors. The role includes educating potential participants and caregivers about protocol-specific details and expectations, as well as performing safety and efficacy assessments such as vital signs, EKGs, and blood draws, as assigned. Other duties may be assigned. This is an indoor, office-environment position. Work may involve shift work depending on location, and overnight travel may be required for training or investigative meetings. The position is lightly active and includes sitting, typing, standing, and walking, with occasional lifting of up to 20 pounds and rare lifting of more than 20 pounds. Reporting to work as scheduled is essential.

Requirements

High school graduate or equivalent.
0–3 years of experience in the medical field.
Knowledge and understanding of federal regulations protecting human subjects in research and governing the conduct of 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.

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 documents, 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.