Site Coordinator - İstanbul; Experienced

Title :
Site Coordinator

Department :
Site Operations Management

Reporting Position :
Team Lead (Site Management)

Location : İstanbul (Onsite)

The Site Coordinator is responsible for the effective management and conduct of clinical trials under the supervision of the Principal Investigator. This role includes planning daily activities, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP). The Site Coordinator facilitates communication between the sponsor, internal and external stakeholders, and ensures the secure collection of study data, the protection of volunteer safety, and compliance with regulatory requirements.

If required, reviewing hospital files under supervision of principal investigator in order to help preliminary volunteer screening procedures in the recruitment period, should all necessary permits are obtained, and making efforts to find eligible volunteers,

Providing help to the study personnel who is assigned in the trial in screening volunteers who are deemed eligible to the trial protocol by the principal investigator (appointment organization of volunteers, helping the study personnel assigned in the trial in noninvasive procedures which are authorized by the principal investigator),

Organizing and monitoring appointments in order to make volunteer visits are performed intimely manner,

Making necessary preparations in order to help the principal investigator perform procedures in accordance with the trial protocol during visits (for example, making list of procedures to be performed and reminding them to the principal investigator or other investigators),

Sending blood samples drawn from volunteers to central or local laboratory as per the trial protocol, organization, tracking of courier procedures, monitoring laboratory reports, making the investigator examine reports, filing reports, informing those concerned for taking immediate measure if there is a remarkable or labeled abnormal finding in the report,

Providing help in recording information of volunteers completely to reference documents (patient file, study file) of the hospital,

Making the investigator evaluate and undersign documents such as laboratory results, ECG examinations, IVRS confirmation faxes and scales, which are amended specifically for the study, in a complete and timely manner and if required, making them filed

Taking necessary measures in order to ensure adequate amount of study materials, patient diaries, laboratory kits, patient identification cards and is available throughout the study,

Relevant form for safety notifications which fulfill definition of serious adverse event reported by the volunteers is filled in by the investigator and it is immediately notified to the sponsor and monitoring such events (for example, discharge reports of patients, hospitalization records or supplying death reports),

• A minimum of a bachelor’s degree
• Information about regulatory requirements and Good Clinical Practice (GCP) guidelines.
• At least intermediate level English.
• Ability to manage time effectively and handle multiple tasks simultaneously.
• Ability to handle sensitive information ethically and professionally.
• At least 1 year of experience in clinical studies

• Master’s or PhD Degree
• Preferably a graduate in health sciences or related fields
• Ability to identify problems, develop solutions, and effectively implement corrective actions.
• Excellent verbal and written communication skills.
  
  Strong teamwork and ability to establish effective collaboration with stakeholders.
• Flexibility and ability to quickly adapt to changing conditions.
• Strong analytical skills

• Meaningful Contribution to Healthcare
• Great team of smart people, in a friendly and open culture
• Collaboration with Professionals (Investigators, sponsors, CROs and other stakeholders)