Clinical Research Coordinator Sr.

Job Summary

Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Essential Responsibilities And Duties

• Captures and organizes research information for clinical trials.
• Observes subjects and assists with data analysis and reporting.
• Manages, monitors, and reports research data to maintain quality and compliance.
• Performs administrative and regulatory duties related to the study as appropriate.
• Participates in other protocol development activities.
• Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.
• Sets up and coordinates study logistics, including scheduling and collecting data.
• Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
• Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.).
• Edits and educates potential participants and caregivers on protocol specific details and expectations.
• Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
• Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities.
• Affirms and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness.
• Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators.
• Assumes other duties and responsibilities as assigned.

Qualifications

• Mastery of Clinical Research Coordinator II position.
• Bachelor's degree, preferred.
• CCRC certification preferred.
• 5 years of experience in the medical field or Masters Degree, preferred.
• Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
• Strong leadership and mentorship skills.
• Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
• Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
• Must be able to effectively communicate verbally and in writing.

Pay

$35-$41/hr depending on education, experience, and skillset.

Schedule

Shift work, depending on location.

Benefits

• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Ins
• 401k

Company Information

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.