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Location: Remote Position
Pay Range: $20.78 - $36.53
Job Description Summary:
The Research Document Control Specialist is responsible for managing, organizing, and maintaining essential research documents across multiple clinical trials. This position ensures compliance with regulatory requirements, internal SOPs, and study protocols by supporting accurate documentation, version control, and timely dissemination of essential documents. The specialist plays a critical role in ensuring inspection-readiness and smooth audit processes. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.
Primary Key Performance Area:
KPA - Maintains central regulatory files in accordance with site SOP.
Adhere to and maintain working knowledge of AON policies, the Federal regulations, ICH, and GCP guidelines. In compliance with the Code of Federal Regulations under the Health Insurance Portability and Accountability Act (HIPAA), assure that patient records will be kept confidential and secure. Maintain and manage electronic and physical Trial Master File (TMF) or Investigator Site File (ISF) documents in accordance with ICH-GCP, FDA regulations, and sponsor requirements. Coordinate collection, review, and filing of essential regulatory documents during study start-up, conduct, and close-out phases. Perform document quality control to ensure accuracy, completeness, and consistency across all study documentation. Track document versions and maintain audit trails for regulatory and sponsor audits. Collaborate with Clinical Research Coordinators, Regulatory Specialists, and Sponsors/CROs to resolve document queries and obtain missing documents. Ensure timely archiving and destruction of documents in accordance with company policies and regulatory guidelines. Support inspection-readiness initiatives by maintaining accurate documentation logs and compliance with internal document control SOPs. Assist in implementation of document management systems and participate in system validation and updates. Maintain credible documentation by using ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete). Support GCP and protocol specific training for staff and investigators by:
Upload and archive protocol specific training modules for all studies. According to site SOP, distribute training module assignments and maintain documentation GCP training for all research staff and investigators. Performs other duties and projects as assigned.
Position Qualifications/Requirements:
Education:
High school education required Associates or Bachelors' degree in Biological Science, Social Sciences, English, or other related field preferred
Certifications/Licenses:
Previous Experience:
Core Capabilities:
Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment. Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback. Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations. Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites. Computer Skills:
Travel: 0% <25% Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM. #AONA
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American Oncology Management Company
$20.78 - $36.53
Oct 22, 2025