Clinical Research Coordinator II

CenExel•Atlanta, GA

7d•Onsite

About The Position

The Clinical Research Coordinator II coordinates all aspects of clinical trials while adhering to 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 trial information, schedules data collection, observes participants, and assists with data analysis and reporting. The coordinator monitors research data for quality and compliance and reviews and reports adverse events, protocol deviations, and other unanticipated problems. The role also performs study-related administrative and regulatory duties, participates in protocol development activities, and ensures the site receives accurate information and supplies from sponsors. The coordinator educates potential participants and caregivers about protocol-specific details and expectations and conducts safety and efficacy assessments as assigned. The position assists the Clinical Trial Manager with vendor oversight, accounting, regulatory matters, client satisfaction, recruitment, quality, trial outcomes, planning, process development, training, and staff development. Other duties may be assigned. The work is performed indoors in an office environment. Shift work may depend on location, and overnight travel may be required for training or investigative meetings. Physical demands include sitting, typing, standing, walking, and 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 graduation 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 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.
CCRC certification.
Two to three years of experience in the medical field.

Responsibilities

Coordinate aspects of 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 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 about protocol-specific details and expectations.
Perform safety and efficacy assessments per protocol, such as 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.

Benefits

Competitive compensation.
Health insurance.
Dental insurance.
Vision insurance.
Long-term disability insurance.
Short-term disability insurance.
Life insurance.
401(k).
Benefits are available to full-time employees after 30 days of employment.
Work environment promoting teamwork, positive leadership, and work-life balance.