Clinical Research Coordinator

CenExel•Decatur, GA

19d•Onsite

About The Position

The Clinical Research Coordinator coordinates clinical trial activities in accordance with ICH, GCP, study protocols, and company guidelines, regulations, and policies. Under supervision, the role coordinates patient involvement in complex or multiple studies from initiation through completion, organizes research information, supports data collection and analysis, and monitors research data for quality and compliance. The coordinator also handles study-related administrative and regulatory duties and may participate in protocol development activities. The role educates potential participants and caregivers about study requirements and performs protocol-specific safety and efficacy assessments, including vital signs, EKGs, and blood draws. It assists the Clinical Trial Manager with vendor oversight, accounting, regulatory matters, client satisfaction, recruitment, quality, trial outcomes, and staff planning, processes, training, and development. Other duties may be assigned. The position is based in an indoor office environment. Work may involve shift schedules depending on location, and overnight travel may be required for training or investigator meetings. The work includes sitting, typing, standing, and walking, with occasional lifting of up to 20 pounds. Reporting to work as scheduled is essential.

Requirements

Proper experience and demonstrated mastery of the Clinical Research Coordinator I position.
High school graduate or equivalent.
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 across 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.
CCRC certification.
2–3 years of experience in the medical field.

Responsibilities

Coordinate patient involvement for complex and/or multiple studies from study initiation through study completion under supervision.
Organize research information for clinical trials.
Observe subjects and assist with data analysis and reporting.
Schedule data collection.
Review and appropriately report adverse events, protocol deviations, and other unanticipated problems.
Monitor and report research data to maintain quality and compliance.
Perform administrative and regulatory duties related to studies as appropriate.
Participate in 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 about protocol-specific details and expectations.
Perform protocol-specific safety and efficacy assessments, 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 with planning, process creation, training, and staff development.
Assume other duties and responsibilities as assigned.