Quality Systems Document Analyst

Cynet Systems
Cincinnati, OH
$24,89-$29,89 an hour
Full-time

Job Description :

Pay Range $24.89hr - $29.89hr

Responsibilities :

  • Administer the approval process of research protocols using PUBSTRAT, including basic quality control, according to standardize procedures.
  • Administer the approval process of scientific publication submissions using PUBSTRAT, including basic quality control, according to standardized procedures
  • Maintain entries into research process trackers and summarization of information for reporting to senior leadership.
  • Assist in the development and updating / maintenance of PUBSTRAT administrators process guidelines.
  • Serve as the main point of contact with the vendor of the PUBSTRAT platform.
  • Document Preparation : memorandums, correspondence, and / or presentations as needed.
  • File management (e.g., Microsoft 365 Teams, SharePoint, Word, Adobe).
  • Assist in the critical review and proofread of standardize process documents.
  • Assemble relevant data, generate reports, compile statistics or information as directed (as needed).
  • Conduct debarment / exclusion checks.
  • Assist in the development and maintenance of training curricula in ComplianceWire
  • Flexibility to accommodate a changing work schedule and sensitivity to international time zones is required.
  • Develop in-depth knowledge of the department’s research processes, policies, and procedures.
  • Acquire knowledge of department organizational structure.
  • Collaborate with administrative staff colleagues to ensure office efficiencies.
  • Maintain client Credo objectives.
  • Assist with Purchase Order requests and processing.
  • Provide other administrative support as assigned by the Associate Director.

Qualifications :

  • A minimum of an associate degree is required. A bachelor’s degree is preferred.
  • Experience with publication management systems (e.g., PUBSRAT, PubPro) is highly preferred.
  • Basic understanding of research methodologies (in clinical / health preferred)
  • Knowledge in regulatory and / or compliance in health care industry (e.g., clinical research, trials, health outcomes research) is highly preferred.
  • Basic understanding of scientific publication methodologies is preferred.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe) is required
  • Ability to learn specialized computer (or Web-based) software used for document approval processes, training curricula, and other applications.
  • Prior experience with creating standardized operating procedures is preferred
  • Must have excellent time management skills.
  • Must have good verbal and written communication and interpersonal skills.
  • Must have strong organizational skills, along with excellent judgment and reasoning abilities.
  • Must be a strong team player with the ability to coordinate with other HEMA associates and research partners.
  • Ability to multi-task and work under minimal supervision, in a dynamic, fast-paced, multicultural, international environment is required.
  • 30+ days ago
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