Corbus Pharmaceuticals

QA Engineer

• The Director, Clinical Quality Assurance, reporting directly to the Senior Director, Head of Quality, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities
• Manage the GCP Quality interface and support for all Clinical Project Teams
• Identify and access compliance risk and develop and implement risk mitigation measures
• Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents
• Review and approve Clinical SOPs
• Develop and Implement Clinical QA SOPs
• Develop and implement detailed audit plans and yearly GCP audit schedules
• Ensure the timely and effective follow up of all identified or assigned quality issues
• Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested
• Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans
• Direct and/or deliver yearly GCP training for internal staff as needed
• Work closely with Clinical Development, Clinical Operations, and other clinical functions/departments to ensure compliance readiness
• Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies
• Provide management reports on audit strategy, plans, and findings
• Support process improvement initiatives; lead continuous improvements within Quality
• Maintain knowledge of GCP regulations, guidelines, company standards and procedures
• Preferred experience in providing oversight and supporting GLP related studies

Director, Clinical Quality Assurance – GCP

Clinical Research

• This role reports through the Clinical function which provides scientific expertise necessary to design, implement and interpret data from clinical studies.
• The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies in collaboration with Clinical Operations and Chief Medical Officer.
• This role will be responsible for the scientific aspects global clinical trial delivery including protocol design and writing, analysis of data, management and reporting of trials in accordance with company plans/objectives, ICH-GCP, country requirements and company standard operating procedures.
• Specifically, this includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, supporting site selection, data review and writing/reviewing the clinical study report, for one or more clinical trials.
• Other important tasks will be supporting the Chief Medical Officer and Chief Operating Officer planning, publication strategy and other tasks.

Director, Clinical Quality Assurance – GCP

Temporary Clinical Scientist