Clinical Research Coordinator

CenExel•Decatur, GA

18d

About The Position

The Clinical Research Coordinator coordinates all aspects of clinical trials while adhering to ICH, GCP, study protocols, and company guidelines, regulations, and policies. Under supervision, the coordinator supports patient involvement in complex and/or multiple studies from initiation through completion, organizes trial information, schedules data collection, observes subjects, and assists with data analysis and reporting. The role also supports study safety, efficacy, quality, and compliance, and performs administrative, regulatory, and protocol-development activities as appropriate. The coordinator works with potential participants and caregivers to explain protocol-specific details and expectations, performs protocol-required assessments, and helps ensure the site receives accurate study information and supplies from sponsors. The position also assists the Clinical Trial Manager with vendor oversight and other trial operations, including accounting, regulatory matters, client satisfaction, recruitment, quality, outcomes, processes, training, and staff development. Work takes place in an indoor office environment; shift work depends on location, and overnight travel may be required for training or investigative meetings.

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 organizational levels, 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 essential physical requirements, including sitting, typing, standing, walking, and occasional lifting of up to 20 pounds.
Ability to report to work as scheduled.
Ability to travel overnight for training and/or investigative meetings if required.

Nice To Haves

CCRC certification preferred.
Two to three years of experience in the medical field preferred.

Responsibilities

Coordinate aspects of patient involvement for complex and/or multiple studies from study initiation through completion, under supervision.
Organize research information for clinical trials.
Observe subjects and assist with data analysis and reporting.
Schedule the collection of data.
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 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.
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.
Perform other assigned duties and responsibilities.