Clinical Research Coordinator II

CenExel • Atlanta, GA

7d

About The Position

The Clinical Research Coordinator II coordinates aspects of complex and/or multiple clinical trials, from study initiation through completion, under supervision. The role requires strict adherence to ICH, GCP, study protocols, and company guidelines, regulations, and policies. The coordinator organizes research information, observes subjects, supports data analysis and reporting, schedules data collection, and monitors research data for quality and compliance. The role also includes administrative and regulatory duties, participant education, safety and efficacy assessments, and support for the Clinical Trial Manager with trial operations and staff development.

The position is based in an indoor office environment and may involve shift work depending on location. Essential physical activities include sitting, typing, standing, and walking, with occasional lifting of up to 20 pounds. Reporting to work as scheduled is essential. Overnight travel may be required for training and/or investigative meetings.

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 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 perform essential physical activities including sitting, typing, standing, and walking, with occasional lifting of up to 20 pounds.
• Ability to report to work as scheduled.
• Willingness to travel overnight for training and/or investigative meetings, as required.

Nice To Haves

• Bachelor's degree preferred.
• 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 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 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 as appropriate.
• Participate in other 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 in planning and creating processes and trainings, and in staff development.
• Assume other duties and responsibilities as assigned.

Benefits

• Competitive compensation.
• Benefits package for full-time employees after 30 days, including health insurance, dental insurance, vision insurance, LTD, STD, life insurance, and 401(k).
• Work environment emphasizing teamwork, positive leadership, and work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED