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Senior Clinical Research Associate (Level dependent on experience)

What You’ll Do

- Serve as main CTI contact for assigned study sites.
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP.
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection.
- Collect, review and track essential/regulatory documents.
- Participate in and complete all general and study specific training as required.
- Participate in investigator, client and project team meetings; may include presentations.
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials.
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager.
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan.
- Assist with project-specific activities as member of Project Team.
- Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures.
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ Client.
- Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments.




- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
- Identify and anticipate site issues and implement corrective and preventive actions or elevate as appropriate.
- Liaise with Clinical Data Management for data cleaning activities.
- Serve as mentor / trainer for CRAs; may include conducting training/assessment visits.
- Function in the role of Lead CRA for assigned project(s).

What You Bring

- 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.
- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources.
- Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO.

Benefits

- Support for career progression – Promote from within, structured mentoring program and program for recent graduates to provide the support employees need to move forward.
- Education and training – Tuition assistance, partnership with universities and colleges to create programs in our field, and a dedicated training department.
- People-focused – No layoffs in our three-decade history; guaranteed full pay during COVID-19 shut-down regardless of hours worked; generous vacation time, hybrid work-from-home schedule, and paid parental leave.
- Unparalleled culture – Multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area and one of the top CROs in the industry.
- Integral reach with local action – Employees across 60 countries; maintaining culture and connections to local communities worldwide; CTI Cares Committees translate culture and values globally.
- Future-oriented growth – Consistent double-digit growth rate over the last decade; investing in cutting-edge technology.

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Postúlate en Kit Empleo: kitempleo.cl/empleo/1djsgm

📌 Senior Clinical Research Associate (Level Dependent On Experience) (Santiago)
🏢 CTI Clinical Trial Services
📍 Santiago