Quality Assurance Specialist at Afro-Reach Clinical Research Organization

Job Description

• The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of Afro-REACH Research Organization’s clinical teams.
• This full-time position partners and collaborates with core members of the clinical trial teams from the sponsor and across research staff at site level to address findings, provide solutions for improvement, and ensure compliance within their area of expertise.
• The Quality Assurance Specialist will oversee audits and inspections and work cross-functionally to support continuous quality enhancement across ARO.

Responsibilities

• Travel to sponsor sites to QA reviews of clinical trials and processes for adherence to SOPs, policies, and NHREC and NAFDAC guidelines
• Prepare reports and discuss non-compliance and quality findings with sponsors and within ARO to identify solutions and action plans
• Provide guidance and root-cause analysis to mitigate identified challenges and gaps in processes
• Work closely with clinical teams and Principal Investigator as needed to identify gaps and ensure continuous process improvement
• Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate
• Implements quality management plans including risk identification and assessment through data review and quality control processes
• Provides consultation and corrective action plans in a timely manner and identifies preventative actions for site staff and clinical trial operations.
• Provides guidance on relevant updates to assist with the improvement and updates in relevant SOPs, policies, and training as needed
• Conducts Quality Assurance training for employees and new hires when needed
• Conducts review of training records and identified SOPs to ensure assigned sites are maintaining compliance with training curriculum
• Stay up to date on relevant clinical trial requirements, NAFDAC, NHREC, GCP, ICH, and other relevant guidelines within Sub-Saharan Africa and other regions relevant for ARO
• Identify and escalate significant compliance issues as according to SOPs
• Identify training gaps and ensure periodic training for ARO employees
• Assist with quality incident and compliance investigations as required.

Qualifications

• Bachelor’s Degree or equivalent related experience
• Strong working knowledge of medical terminology, SOPs, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), applicable regulatory requirements, and quality management processes
• 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role
• Direct experience in the conduct and reporting of internal and external audits preferred
• Excellent interpersonal, verbal, and written communication skills
• Client and patient-focused approach
• Thrives in a fast-paced environment with the ability to work independently, be proactive, and have a nimble approach with respect to day-to-day activities
• Ability to multi-task and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively with cross-functional teams to foster teamwork within the group as well as across ARO
• Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams.
• Maintains a strong level of integrity and good judgement at all times
• Experience of inspection management
• Fundamental knowledge of in-country and international regulatory standards and guidelines for the conduct of clinical trials
• Knowledge of data integrity controls and systems quality for clinical area
• Strong analytical skills and report writing skills
• Ability to demonstrate tact as a representative of the CQA Department
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
• Ability to Travel (approximately 25%)

Preferred Qualifications:

• Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits also preferred
• Clinical Research or Quality Certification preferred.