Compliance Specialist, QA Clinical Studies

Job description

  Job facts

POSITION SUMMARY:

Responsible for activities related to the quality oversight of clinical studies. Ensures studies are recorded and reported in accordance with protocol, standard operating procedures, Good Clinical Practices (e.g., ICH E6) and other applicable regulatory requirements (e.g., CAP CLIA). This position will work closely with the Regulatory Compliance Manager to increase study/process quality and organizational efficiency. Performs internal and external audits ensuring compliance with all Food and Drug Administration, World Health Organization and Biological Licensing Agreements guidelines for regulatory standards, as well as company policies/procedures.Assists with the development of and coordinateswith Clinical Standard Operating Procedures and Clinical Operating Procedures to ensure compliance with the Food and Drug Administration and global regulatory organizations. Maintains clinical quality database of observations, as required by clinical quality management, for quality analysis and assessment and identifies compliance risk.Assists with the conductofpre- and post-study document reviews and takes corrective action. Performs technical document review and other good manufacturing practices activities in support of clinicalquality activities.Assists clinical quality management with creation of audit reports.

ESSENTIAL FUNCTIONS:

·  Acts as the Quality Subject Matter Expert ensuring that clinical studies, under regulatory compliance quality oversight, are conducted in compliance with Good Clinical Practices and Good Laboratory Practices where appropriate.
·  Actively monitors and controls study documentation to ensure compliance on a study level. Guides study managers and monitors in assuring documentation compliance.
·  Educates staff (study managers, study coordinators/monitors) on quality standards, documentation guidelines and corrective actions.
·  Liaisons with other departments and organizations on quality standards, documentation guidelines and study start-up activities.
·  Participates in the preparation of internal and external audits. Supports the site during an audit by providing documentation, documenting findings and report of findings.
·  Assists in study setup and documentation toward rapid, compliant and where applicable paperless documentation.
·  Reviews regulated study protocols, reports, Adverse Events, study data, investigator files, and related study documentation.
·  Reviews and approves quality system document changes.
·  Performs tracking and trending of quality metrics as applicable.
·  May perform other duties as required or assigned.

MINIMUM QUALIFICATIONS:

Formal Training/Education:

·  Bachelor's Degree or equivalent combination of education and experience.

Experience:

·  Minimum of 5 years' experience in the Medical Device/Pharmaceutical Industry, preferably with IVDs.
·  1 year previous experience with clinical studies is preferred.
·  Knowledge of clinical research activities and/or good clinical practice requirements is preferred.

Knowledge, Skills, and Abilities:

·  Knowledge of Clinical Study regulations, guidance documents, and requirements.
·  Understanding of quality principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, leadership, training, improvement systems, and professional ethics.
·  Ability to develop, implement, and take limited responsibility for quality programs, including the tracking, analyzing, reporting and problem solving associated with system improvements.
·  Ability to plan, control, and assure quality in accordance with quality principles which include change control, data control, and planning processes.
·  Basic knowledge of regulated quality systems.
·  Understanding of relevant ISO, CAP/CLIA, GCP, and US FDA regulations and guidelines.
·  Ability to plan and organize work.
·  High degree of accuracy and quality.
·  Ability to communicate and represent the quality position and requirements to peers & others.
·  Computer literate (Word, Excel, Access, PowerPoint).
·  Impeccable record keeping and filing skills.
·  Excellent time management skills.

·  Who we are

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.