Clinical Research Coordinator

CenExel•Decatur, GA

17d

About The Position

The Clinical Research Coordinator coordinates clinical trial activities in accordance with ICH, Good Clinical Practices, study protocols, and company guidelines, regulations, and policies. Under supervision, the coordinator manages patient-related aspects of complex or multiple studies from initiation through completion, organizes trial information, schedules data collection, and observes participants while supporting data analysis and reporting. The role reviews and reports adverse events, protocol deviations, and other unanticipated problems, and monitors research data to maintain quality and compliance. The coordinator performs study-related administrative and regulatory duties, contributes to protocol development, and helps ensure the site receives accurate sponsor information and supplies. They educate potential participants and caregivers about study protocols and expectations and conduct safety and efficacy assessments, such as vital signs, EKGs, and blood draws, as assigned. The role also assists the Clinical Trial Manager with vendor oversight, accounting, regulatory matters, client satisfaction, recruitment, quality, trial outcomes, planning, processes, training, and staff development. Other duties may be assigned.

Requirements

Must have proper experience and demonstrate mastery of the Clinical Research Coordinator I position.
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.

Nice To Haves

CCRC certification preferred.
2–3 years of experience in the medical field preferred.

Responsibilities

Coordinate patient involvement in complex and/or multiple studies from study initiation through study completion.
Organize clinical trial information and schedule data collection.
Observe subjects and assist with data analysis and reporting.
Review and report adverse events, protocol deviations, and other unanticipated problems appropriately.
Monitor and report research data to maintain quality and compliance.
Perform administrative and regulatory duties related to studies.
Participate in 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 about protocol-specific details and expectations.
Perform safety and efficacy assessments per protocol, including vital signs, EKGs, blood draws, and other assigned assessments.
Assist the Clinical Trial Manager with oversight of vendors, accounting, regulatory matters, client satisfaction, recruitment, quality, and trial outcomes.
Assist the Clinical Trial Manager in planning and creating processes and trainings, and in staff development.
Assume other duties and responsibilities as assigned.