Site Coordinator - Samsun (Experienced)

Medex Smo; İlkadım; On-site; TRY 240,000 - 380,000; Full time

Job summary

Medex Smo is seeking a Site Coordinator to oversee the daily conduct of clinical trials under the PI. You will plan activities, ensure protocols and GCP compliance, and safeguard volunteer safety while coordinating data collection and communications with sponsors and stakeholders.

Responsibilities include screening volunteers with PI supervision, organizing visits, assisting with procedures, processing samples to labs, and maintaining accurate study records.

Qualifications

• Bachelor's degree and knowledge of regulatory requirements and GCP.
• At least intermediate level English.
• Ability to manage time effectively and handle multiple tasks.
• Ability to handle sensitive information ethically and professionally.
• At least 2 years of experience in clinical studies.

Responsibilities

• Plan daily activities and coordinate study conduct under PI supervision.
• Ensure compliance with study protocols, regulatory requirements, and GCP.
• Facilitate communication between sponsor and stakeholders; ensure data collection and volunteer safety.
• Review hospital files for preliminary volunteer screening under supervision.
• Organize and monitor appointments and volunteer visits in a timely manner.
• Prepare procedures lists and remind investigators during visits.
• Coordinate sending blood samples to labs and monitor reports.
• Record volunteer information in hospital study files.
• Ensure study materials and diaries are available throughout the study.
• Notify sponsor and monitorings of serious adverse events.

Skills

Time management

Ethical conduct

Clinical studies

English communication

Education

Bachelor's degree

Health sciences degree

Master's degree

Job description

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.

Key Responsibilities

If required, reviewing hospital files under supervisionof principal investigator in order to help preliminary volunteer screeningprocedures in the recruitment period, should all necessary permits areobtained, and making efforts to find eligible volunteers,

Providing help to the study personnel who isassigned in the trial in screening volunteers who are deemed eligible to thetrial protocol by the principal investigator (appointment organization ofvolunteers, helping the study personnel assigned in the trial in noninvasiveprocedures which are authorized by the principal investigator),

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

Making necessary preparations in order to helpthe principal investigator perform procedures in accordance with the trialprotocol during visits (for example, making list of procedures to be performedand reminding them to the principal investigator or other investigators),

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

Providing help in recording information ofvolunteers completely to reference documents (patient file, study file) of thehospital,

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

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

Relevant form for safety notifications which fulfilldefinition of serious adverse event reported by the volunteers is filled in bythe investigator and it is immediately notified to the sponsor and monitoringsuch events (for example, discharge reports of patients, hospitalizationrecords or supplying death reports),

Must Have

• A minimum of a bachelor's degree
  
• Informationabout 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 2year of experience in clinical studies
  

Nice to Have

• 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
  

What's great in the job?

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