Clinical Research Compliance Specialist

Job Description

Job Description

Summary : The Clinical Research Compliance Specialist supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, writing monitoring reports, and developing risk monitoring plans and study-related documents.

Essential Duties and Responsibilities :

• Conduct SOP / GCP / Compliance Training with coordinators at site.
• Ensure sites are adhering to ACN’ s policies and procedures.
• Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity.
• Ensure valid findings from the audit / inspection report are managed effectively by the organization, and in accordance with our procedures. Escalate significant findings to CTNx Management.
• Coach and Support CRCs and PIs on a continuous basis based upon audit findings.
• Monitor the protocol and regulatory compliance of clinical research studies (with low —to high-risk research designs) in multiple treatment areas.
• Review research data from source documentation for accuracy, completeness, and timeliness.
• Collaborate with the offshore compliance team and the onsite study team to effectively address critical findings.
• Strictly adhere to confidentiality and compliance standards.
• Collect, review, maintain, and audit essential documents
• Assist with developing documents and implementing study-specific risk monitoring plans.
• Support ongoing communication with study teams regarding trial qualification, initiation, monitoring, remote monitoring, and close-out activities.
• Serves as the main point of contact in compliance audits and interim monitoring visits.
• Read and comprehend new research protocols as well as amended protocols.
• Meet assigned targets, goals, and completion deadlines.
• Utilize analytical, problem-solving, and critical thinking.
• Utilize precise attention to detail.
• Perform other duties as assigned to meet the goals and objectives of the department and institution
• Comply with all company policies, procedures, and conduct.

Qualification Requirements : To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Education and Experience :

Special Skills, Knowledge, and Abilities :

Certificates, Licenses, Registrations : Maintain GCP certification and other on-the-job certifications as required.

Travel Required : 5-10%

Physical Demands and Working Conditions : The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job.

While every attempt has been made to outline the basic job responsibilities, adjustments in the process may change and expand the job duties. In addition, employees may be asked to perform duties outside of this description at the discretion of the Executive Management Team.

BENEFITS :

WORK LOCATION : Lewisville, Texas