Senior Clinical Research Associate

hace 5 días

Partido de Vicente López, Argentina CTI Clinical Trial Services, Inc A tiempo completo
About the Role

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at CTI Clinical Trial Services, Inc. As a Senior Clinical Research Associate, you will play a critical role in the success of our clinical trials by ensuring the highest level of quality and compliance.

Key Responsibilities
  • Site Management: Serve as the primary point of contact for assigned study sites, ensuring seamless communication and collaboration.
  • Monitoring and Quality Assurance: Conduct site visits, complete site visit deliverables, and ensure adherence to regulatory requirements, SOPs, and ICH GCP.
  • Study Start-Up: Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection.
  • Document Management: Collect, review, and track essential and regulatory documents.
  • Training and Development: Participate in and complete all general and study-specific training as required.
  • Communication and Collaboration: Participate in investigator, client, and project team meetings, and may include presentations.
  • Subject Enrollment Strategies: Create and implement subject enrollment strategies for assigned study sites.
  • Investigational Product Management: Ensure proper storage, dispensation, and accountability of all Investigational Product and trial-related materials.
  • Site Management Activities: Perform site management activities and provide ongoing updates of site status to Clinical Project Manager.
  • Remote Monitoring: Conduct remote monitoring and complete related activities in accordance with study-specific Monitoring Plan.
  • System Utilization: Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP.
  • Project-Specific Activities: Assist with project-specific activities as a member of the Project Team.
  • Document Development: Participate in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.).
  • Translation and Customization: Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures.
  • Regulatory Support: 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.
  • Contract Negotiation: Where applicable, support or oversee contract negotiation with study sites, Investigator payments, and tracking of site payments.
  • ISF and TMF Management: Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
  • Site Issue Identification and Resolution: Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate.
  • Data Management: Liaise with Clinical Data Management for data cleaning activities.
  • Mentorship and Training: Serve as mentor/trainer for CRAs; may include conducting training/assessment visits.
  • Lead CRA: Function in the role of Lead CRA for assigned project(s).
Requirements
  • Experience: 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.
  • Education: Bachelor's Degree or higher in an 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.
  • Background: Previous experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO.
About CTI Clinical Trial Services, Inc.

At CTI Clinical Trial Services, Inc., we recognize that our people are what make our company successful. Our work moves medicine forward. We treat our team members with the respect they deserve, and our numbers show it:

  • We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward.
  • We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department.
  • We value our people - We have never had a layoff in our three-decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work-from-home schedule, and paid parental leave.
  • Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry.
  • We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
  • We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs.
  • Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market.

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