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Clinical Research Associate II

Pharma UniverseTR

12 gün önce

İş tipi

İş tanımı

Clinical Research Associate II (Türkiye)

Responsibilities :

Conduct site visits, including site selection, initiation, routine monitoring, and close-out visits , ensuring compliance with ICH-GCP, study protocols, and regulatory requirements.
Monitor patient safety, data integrity, and protocol adherence , identifying and resolving issues proactively.
Ensure that investigational sites maintain accurate study documentation and adhere to Good Documentation Practices (GDP).
Work across sponsor-dedicated and multi-sponsor studies , managing multiple protocols and therapeutic areas.
Provide training and support to site staff on study procedures and protocol compliance.
Review and verify case report forms (CRFs) and electronic data capture (EDC) systems for data accuracy and completeness.
Maintain effective communication with investigators, site staff, sponsors, and internal teams to ensure study timelines are met.
Assist in the resolution of site-specific issues, queries, and deviations , escalating as necessary.
Support in ethics submissions, regulatory documentation, and site feasibility assessments where required.
Contribute to continuous process improvement and ensure adherence to SOPs and company policies .

Requirements :

Minimum of 2 years’ independent monitoring experience in clinical research.

Strong understanding of ICH-GCP, regulatory guidelines, and clinical trial operations .

Experience in both sponsor-dedicated and multi-sponsor settings is preferred.

Ability to manage multiple sites and protocols across different therapeutic areas.

Excellent communication, problem-solving, and relationship-building skills.

Ability to travel as required for site monitoring visits.

Degree in Life Sciences, Pharmacy, Nursing, or a related field .