Site Care Partner I, SrCRA – FSP, Sponsor Dedicated

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Conducts site qualification, initiation, interim monitoring, site management, and close-out visits, whether performed on-site or remotely, ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and protocol requirements.

• Utilizes judgment and experience to assess the overall performance of the site and its staff, providing recommendations for site-specific actions; promptly communicates and escalates critical issues to the project team while formulating action plans.

• Maintains up-to-date knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Confirms that the process of obtaining informed consent has been properly executed and documented for each subject or patient as necessary.

• Exhibits diligence in safeguarding the confidentiality of each subject or patient.

• Evaluates factors that may impact the safety of subjects/patients and the integrity of clinical data at an investigator or physician site, including protocol deviations, violations, and pharmacovigilance concerns.

• In accordance with the Clinical Monitoring/Site Management Plan (CMP/SMP), assesses site processes.

• Performs Source Document Review of relevant site documentation and medical records.

• Ensures that clinical data recorded in the case report form (CRF) is accurate and complete through the review of site source documents and medical records.

⛳️ Requirements

• Bachelor's degree or RN in a related field, or a comparable combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Proficient computer skills and the ability to adapt to new technologies.

• Outstanding communication, presentation, and interpersonal abilities.

• Moderate critical thinking skills are expected.

• Willingness to manage travel requirements of up to 75% regularly.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and progression, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.

• Driven to Deliver, capturing our colleagues' passion to show up daily and create solutions that can significantly impact someone's life.

• We are continually working to build the company we aspire to work for, and that our customers wish to partner with.