Key Responsibilities

According to the Guideline on Site Management Organization Principles:

• Visiting reference centers, if there are reference centers which ensure referral of patients meeting study criteria to the study site, visiting physicians of the site and reminding voluntary screening conditions,
• 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),
• Filing the informed consent forms obtained from volunteers, reminding the principal investigator give one copy of the form to the volunteer,
  Organizing and monitoring appointments in order to make volunteer visits are performed in timely 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 who is principal investigator or physician or dentist examine reports, filing reports, informing those concerned for taking immediate measure if there is a remarkable or labeled abnormal finding in the report,
• Assisting the investigator who is principal investigator or physician or dentist in recording all procedures in a complete manner and in filing the documents,
• Providing help in recording information of volunteers completely to reference documents (patient file, study file) of the hospital,
  Within the authorization of the coordinator/participant physician, to help entering data obtained from volunteers completely and truly to printed or electronic case report forms (eCRF), volunteer file and screening cards,
• Making the investigator who is principal investigator or physician or dentist 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 who is principal investigator or physician or dentist and it is immediately notified to the sponsor and monitoring such events (for example, discharge reports of patients, hospitalization records or supplying death reports),
• Making all documents, such as investigator’s brochure amendment, protocol amendment and investigator’s notification received during the study, required to be notified in relation with the study to the ethics committee and Turkey Pharmaceuticals and Medical Device Agency are notified and monitoring the decisions on those notifications,
• Filing all correspondences received from the sponsor and the ethics committee to the principal investigator’s file,
• Ensuring that principal investigator answers, in a timely manner, the questions set forth about issues requiring clarification in relation with information of volunteer,
• Supplying necessary volunteer information requested by the department performing the data analysis or by other assessment committees in interim analysis periods while the study is in progress,
• Ensuring that the letter indicating completion of the study is notified to the ethics committee,
• Providing help in establishing a place where study files will be retained,

Communication and Coordination:

• Regularly monitors communication channels such as telephone and e-mail and takes necessary measures on a daily basis to ensure effective communication and timely response.
• Establishes and manages effective communication channels between the site, sponsor, CROs (Contract Research Organizations), auditors, and all other stakeholders. Coordinates sponsor visits and audit processes throughout the project.

Volunteer Expenses & Reimbursements:

• Documents and submits patient expenses and personal expenses to MEDEX in a timely manner in accordance with the relevant SOP (QM-PR-015) and regulations.

Accurate and Timely Enterprise Resource Planning (ERP) Updates:

• Fills out the timesheet daily with completeness and accuracy, allowing for accurate tracking of field personnel's activities and the time invested.
• Ensures the timely submission of detailed weekly reports on ongoing actions, progress, and key deliverables, assuring accuracy and adherence to established deadlines.
• Records and updates relevant entries in the ERP system efficiently, ensuring that all data reflects the current status of clinical research activities accurately.
• Reviews and assesses the accuracy of data entered into the ERP system, collaborating closely with team leaders, the timesheet auditor, and the site manager (if applicable) to identify and resolve discrepancies as needed.

Training and Compliance with Standard Operating Procedures (SOPs):

• Actively participates in all training sessions to develop knowledge and skills related to clinical research operations and regulatory requirements.
• Ensures strict adherence to Standard Operating Procedures (SOPs) at every stage of site operations and maintains compliance with corporate policies and regulatory standards.
• Promotes a culture of compliance and continuous improvement regarding SOPs and best practices.
• Provides feedback on existing SOPs and training programs, suggesting improvements based on practical experiences to enhance site efficiency and compliance.

Leave Planning and Return from Leave:

• Carries out leave planning in accordance with QM-WF-002.
• Ensures that the automatic reply setting is configured in their email account before going on leave.
• Notifies the site responsible and/or team lead at least 1 month before returning from long-term leaves such as maternity leave or unpaid leave, ensuring that planning begins.

Competencies

Education:

• Preferably a graduate in health sciences or related fields, at a minimum a bachelor's degree.

Skills:

• Information about regulatory requirements and Good Clinical Practice (GCP) guidelines.
• Ability to identify problems, develop solutions, and effectively implement corrective actions.
• At least intermediate level English.
• Good computer skills.
• Excellent verbal and written communication skills.
• Strong teamwork and ability to establish effective collaboration with stakeholders.
• Ability to manage time effectively and handle multiple tasks simultaneously.
• Ability to handle sensitive information ethically and professionally.

• Flexibility and ability to quickly adapt to changing conditions.
  

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