Clinical Compliance Specialist

Koç Üniversitesi Hastanesi

Koç Healthcare is the healthcare organization group of the Vehbi Koç Foundation in Turkey. As of March 2022, there are 3 hospitals and a medical center affiliated to Koç Healthcare which are American Hospital, Koç University Hospital, Bodrum American Hospital and American Outpatient Medical Center.  

In 2021, 80.280 International Patients from more than major 25 countries had medical services from Koç Healthcare institutions covering the entire surgical spectrum. Koç Healthcare combines 100 years of accumulated knowledge and experience with the latest technology to provide quality-focused health services in all medical and surgical disciplines to its International Patients.

As Koç Healthcare, we have determined a clinical road map, guidance and algorithms to provide transparent and integrated healthcare services at a standardized level of quality to all of our patients. Our medical and administrative systems are constantly measured and evaluated in order to ensure continuous development.

Key Responsibilities:

• Acting as the GCP Subject Matter Authority; establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key business associates.
• Lead and support process improvement efforts, assessment and alignment to the international standards, local country regulations and guidelines, and review of procedural updates as needed. Participate in departmental initiatives across Clinical organization sought at improving process and efficiency, in particular for the improvement of local processes.
• Support audit-related activities and respond to internal audits includingCorrective and Preventive Action (CAPA) plans, training, and procedure modification and implementation. Some of the audit support activities such as, but not restricted to, acting as a liaison between internal auditors and Clinical Research personnel (CRP), collaborating with CRP to ensure appropriate remediation activities are identified, and supervising the progress of all CAPA and audit deliverables to ensure timely completion. Also, participate in regulatory and notified body audits.
• Conduct quality control activities which include, but not limited to, quality review of clinical trial protocols and associated documents (including, but not limited to, Informed Consent Documents, CRFs, Clinical Study Reports, etc.), as appropriate, to ensure compliance with relevant procedures, standards, and regulations.
• Coordinate and ensure quality of the trial files are performed ensuring compliance with regulations for inspection by health authorities and work in collaboration with the study team to ensure file readiness and provide technical support in preparation for site and incoming audits.
• Perform other work-related duties as assigned by management.

Qualifications

Required:

• A Bachelor’s Degree or equivalent is required, preferably in a scientific or technical concentration.
• 3 years, or more, of Quality Assurance experience and/or 3 years in the Clinical Trials (e.g CRA) environment is required.
• Sophisticated knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g.ICH E6) is required
• Experience in supporting regulatory or notified body audits is required
• Advanced English

Preferred:

• Supervisory experience of at least two (2) years is preferred
• A minimum of 2 years of healthcare compliance field experience is preferred
• Strong understanding of related aspects of Clinical Compliance processes and/or systems.
• Understanding of regulations and standards related to requirements for medical devices.
• Solid understanding of clinical trials and quality systems
• Excellent written and oral communication skills, interpersonal skills, strong negotiating skills, and the ability to empower in a collaborative environment with outstanding service orientation.