What are the responsibilities and job description for the Clinical Research Coordinator position at Elevate Clinical Research?
We are seeking a detail-oriented and proactive Clinical Research Coordinator to support the execution of clinical trials at our Waxahachie, TX site. The CRC will play a key role in ensuring the integrity of study data, participant safety, and compliance with regulatory requirements.
Key Responsibilities
Study Coordination
Support daily operations of clinical trials, including scheduling visits and preparing study materials.
Ensure adherence to study protocols and regulatory guidelines.
Participant Recruitment and Screening
Identify and recruit eligible participants.
Conduct pre-screening interviews and maintain sponsor-provided prescreening logs.
Update Elevate portals with relevant participant information.
Data Collection and Management
Accurately collect and enter study data into databases.
Ensure data integrity and compliance with ALCOA principles.
Patient Care and Communication
Serve as a primary contact for study participants.
Conduct informed consent discussions and review medical histories.
Perform delegated study procedures in accordance with local and state regulations.
Coordination with Healthcare Professionals
Collaborate with physicians, nurses, and other staff to ensure smooth study execution.
Documentation and Reporting
Maintain timely and accurate documentation in both sponsor and site systems.
Quality Control and Audits
Conduct quality control checks and maintain investigational product accountability.
Assist with audit responses and implementation of corrective actions.
Communication and Collaboration
Maintain clear communication with the research team, sponsors, monitors, and participants.
Follow site Standard Operating Procedures (SOPs) and policies.
Participant Interaction
Ensure ethical and regulatory compliance in the informed consent process.
Monitor participant safety and manage adverse events and protocol deviations.
Quality Assurance
Conduct regular data audits to ensure accuracy and completeness.
Monitor protocol adherence and address deviations promptly.
Qualifications
Bachelor’s degree in a health-related field or equivalent experience.
2-5 Years Of Clinical Research Experience Preferred.
Strong organizational and communication skills.
Proficiency in Microsoft Office and clinical data systems.
Certification (e.g., CCRC or CCRP) is a plus.
Why Join Elevate Clinical Research?
Competitive Compensation And Benefits.
Opportunities for professional development.
A collaborative and mission-driven work environment.
Key Responsibilities
Study Coordination
Support daily operations of clinical trials, including scheduling visits and preparing study materials.
Ensure adherence to study protocols and regulatory guidelines.
Participant Recruitment and Screening
Identify and recruit eligible participants.
Conduct pre-screening interviews and maintain sponsor-provided prescreening logs.
Update Elevate portals with relevant participant information.
Data Collection and Management
Accurately collect and enter study data into databases.
Ensure data integrity and compliance with ALCOA principles.
Patient Care and Communication
Serve as a primary contact for study participants.
Conduct informed consent discussions and review medical histories.
Perform delegated study procedures in accordance with local and state regulations.
Coordination with Healthcare Professionals
Collaborate with physicians, nurses, and other staff to ensure smooth study execution.
Documentation and Reporting
Maintain timely and accurate documentation in both sponsor and site systems.
Quality Control and Audits
Conduct quality control checks and maintain investigational product accountability.
Assist with audit responses and implementation of corrective actions.
Communication and Collaboration
Maintain clear communication with the research team, sponsors, monitors, and participants.
Follow site Standard Operating Procedures (SOPs) and policies.
Participant Interaction
Ensure ethical and regulatory compliance in the informed consent process.
Monitor participant safety and manage adverse events and protocol deviations.
Quality Assurance
Conduct regular data audits to ensure accuracy and completeness.
Monitor protocol adherence and address deviations promptly.
Qualifications
Bachelor’s degree in a health-related field or equivalent experience.
2-5 Years Of Clinical Research Experience Preferred.
Strong organizational and communication skills.
Proficiency in Microsoft Office and clinical data systems.
Certification (e.g., CCRC or CCRP) is a plus.
Why Join Elevate Clinical Research?
Competitive Compensation And Benefits.
Opportunities for professional development.
A collaborative and mission-driven work environment.