Clinical Research Associate

AnalitiQ Consultancy Tıbbi Danışmanlık A.Ş

QUALIFICATIONS AND JOB DESCRIPTION

QUALIFICATIONS AND JOB DESCRIPTION

 We are looking for Experienced and Qualified Clinical Research Associates (CRA) with the following qualifications to take part in AC's international projects.

Job Description:

• Performs clinical study site management/monitoring activities in compliance with Good Clinical Practice and associated documents & regulations.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Following the country strategy defined by managers, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
• Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
• Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.

Qualifications

• Minimum of one year of relevant experience within a pharmaceutical company or a CRO with phase I-III studies.
• Fluent in English
• Residing in Istanbul or İzmir
• Be flexible with the ability to travel nationwide.
• Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
• Ability to perform all clinical monitoring activities independently.
• Strong interpersonal, written, and verbal communication skills. 
• Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
• A client-focused approach to work and flexible attitude with respect to assignments/new learning.
• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines.