Clinical Quality Assurance Specialist

Location
Burlingame, California, United States
Posted
Jul 26, 2021
Ref
4488356003
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Inflammatix is seeking a Clinical Quality Assurance Specialist to support Clinical Operations. The Clinical Quality Assurance Specialist will be responsible for overseeing clinical activities for new and existing products to ensure compliance with regulatory requirements for the execution of clinical studies.
  • The primary responsibility of the Clinical Quality Assurance Specialist is to oversee the establishment and maintenance of Clinical Operations SOPs
  • This person is also primarily responsible for the management of all audits (vendor & site) required for the Inflammatix clinical studies, and the conduct of internal and external GCP system and process audits
  • Management and support of quality-related tasks and systems related to clinical studies (i.e., fulfil the responsibilities of the Clinical representative on assigned Project and/or Clinical Study Team/s)
  • Support other Clinical Affairs activities, e.g., policies for advisory panel meetings, KOL interactions, etc
  • Management and support of GCP/BIMO inspections and audits by Regulatory Authorities and Third-Party Contractors
  • Assists Clinical Affairs and Clinical Operations with department SOP lifecycle (author, revisions, etc). May perform periodic GAP assessment on department quality documents and make recommendations
  • To support and comply with the organization's duty of care obligations, in relation to GCP requirements
  • To act as Subject Matter Expert (SME) and as the primary point of contact with clinical affairs and clinical operations teams to provide GCP and process related guidance and support; works with teams to investigate and resolve clinical study related GCP compliance, deviations, and process-related issues, providing recommendations for solutions and CAPAs as needed
  • Maintains up-to-date working knowledge of regulatory standards and guidelines related to Clinical Quality programs. Promotes understanding, communication and coordination of Clinical Quality/compliance initiatives and standards

PRIMARY RESPONSIBILITIES:
  • Comply with all corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice
  • Independently conduct external & internal audits
  • Monitor audit responses and corrective actions to ensure efficacy and completeness
  • Act as CQA Auditing representative in designated study team/s (and back-up as required) and provide internal guidance and consulting for trial GCP issues
  • Act as CQA Auditing representative (and back-up as required) for study documents compliance verification (e.g., product specific/trial specific ICF, protocol, CSR, IB, CRF etc.)
  • Involvement in audit CAPA management (tracking, oversight, follow-up)
  • Audit documentation management and maintenance (including audit logs)
  • Generate and provide metrics, status, and other information in relation with GCP, as required by management
  • Perform other duties as assigned, e.g., GCP training, CQA Auditing, and provide support during Regulatory Authority inspections
  • Provide GCP training to staff as needed
  • Write and contribute to the review of clinical procedural documents, as well as monitor and assess global safety and clinical processes and procedural documents for consistency and with global laws, regulatory requirements, company policies and procedures

MINIMUM QUALIFICATIONS:
  • Bachelor's degree ( preferably in a life or health sciences, nursing, pharmacy, or related field)
  • Prior Clinical Quality Assurance experience required
  • Minimum of 2 years' experience in GCP auditing with FDA/EMA/Global regulatory requirements and ICH guidelines (monitoring and/or device safety or clinical operations experience are acceptable)
  • Experience in regulated environment, preferably medical device industry
  • Ability to travel 10% -15% to clinical trial sites as needed

KNOWLEDGE, SKILLS, AND ABILITIES:
  • High ethical standards and integrity.
  • Ability to work well independently and in a team environment, interact productively, and effectively with peers, management and third parties
  • Proficiency with MS Office including Word, Excel, and PowerPoint
  • Ability to maintain a high level of confidentiality
  • Use resources effectively and reasonably
  • Excellent oral and written communication skills
  • Strong interpersonal and organizational skills
  • Flexibility, recognition of occasional unusual working hours due to international nature of operations

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time position
  • Compensation: Competitive and commensurate with experience; equity package
  • Benefits: Medical, dental, and vision; 401(k) and more

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic pa rtner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.