Alliance Clinical Network · 4 months ago
Clinical Research Compliance Specialist
Zenos/Dallas, Dallas, TX, US
Full-time
Onsite
Entry, Mid Level
2+ years expAlliance Clinical Network is seeking a Clinical Research Compliance Specialist to support clinical research studies by ensuring protocol and regulatory compliance. The role involves monitoring research data accuracy, managing documentation, conducting audits, and developing risk monitoring plans.
Hospital & Health Care
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
Required
At least two (2) years of clinical research experience as a Clinical Research Coordinator (CRC) or one (1) year of experience as a Clinical Research Associate (CRA) is required
Proficient in Microsoft Word, Excel and Adobe Acrobat
Working knowledge of medical and/or clinical trial terminology
Working knowledge in relevant scientific fields
Strong attention to detail
Must be able to prioritize competing demands
Must possess excellent verbal and written communication skills
A proven ability to multi-task in a rapidly changing environment
Maintain GCP certification and other on-the-job certifications as required
Preferred
An associate degree in healthcare or a related field is preferred
Company
Alliance Clinical Network
For more than a decade, Alliance Clinical Network's fully integrated, wholly owned and operated clinical research sites have helped advance human health by delivering exceptional clinical trial data gathered from a proprietary, ready-to-tap, group of >250,000 diverse participants.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Jason Cunio
Chief Financial Officer
Janice Shock, MBA, PHR
Chief Human Resources Officer
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