Research Associate

SoTalent

Fatih

On-site

TRY 350,000 - 500,000

Full time

38 hours ago
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Job summary

Sotalent in Istanbul seeks an experienced Site Monitoring Specialist to manage all on-site activities for clinical trials. You will ensure adherence to study protocols, ICH-GCP guidelines, and local regulations while coordinating sponsor-site communications.

You will perform site visits, monitor data quality, train site personnel, and support regulatory submissions. A life sciences degree and at least one year of on-site monitoring experience are required, with strong English and MS Office

Qualifications

  • Bachelor's degree in life sciences or healthcare field is required.
  • Minimum 1 year of direct on-site monitoring experience.
  • Strong knowledge of GCP/ICH guidelines and trial methodology.
  • Professional English with excellent written and spoken communication.

Responsibilities

  • Conduct site visits to verify data integrity and protocol compliance.
  • Maintain site master files and documentation in line with regulatory standards.
  • Coordinate sponsor-site communications and training.
  • Monitor enrollment, query resolution, and data quality in the TMF.
  • Support regulatory submissions and local approvals as needed.

Skills

On-site monitoring
Multitasking
Communication skills
Team collaboration

Education

Bachelor's degree in life sciences or healthcare

Tools

MS Office
CTMS

Job description

I am currently recruiting for a global leader in healthcare intelligence and clinical development who is seeking an experienced professional to join their monitoring team in Istanbul. This is an excellent opportunity for a clinical research professional to take ownership of site management activities and ensure the highest standards of trial execution.

In this role, you will be responsible for the full lifecycle of site activities, including selection, initiation, routine monitoring, and close out procedures. You will serve as the primary link between the sponsor and the clinical site, ensuring that all operations adhere strictly to study protocols, ICH GCP guidelines, and local regulatory requirements.

Key Responsibilities

Conduct all phases of site visits to verify data integrity and protocol compliance.

Collaborate with sites to establish and maintain effective patient recruitment strategies.

Deliver study specific training to investigators and site personnel.

Monitor site performance and escalation any quality or safety concerns promptly.

Oversee the maintenance of the Trial Master File and Investigator Site Files.

Manage data flow by tracking enrollment, CRF completion, and query resolution.

Produce detailed monitoring reports and follow up correspondence within required timelines.

Support site financial management and local regulatory submission processes as needed.

Candidate Requirements

A university degree in a life sciences or healthcare related field.

At least one year of direct experience performing on site monitoring visits.

Thorough understanding of GCP and ICH frameworks and clinical trial methodology.

Professional fluency in English with strong written and verbal communication skills.

Strong technical proficiency in Microsoft Office and clinical trial management software.

Proven ability to manage multiple priorities and meet tight deadlines.

Strong interpersonal skills with the ability to build rapport with site staff and internal teams.

This organization is dedicated to accelerating medical innovation and improving patient health outcomes worldwide. If you are a motivated professional looking to advance your career with a premier clinical research provider,

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