Senior Clinical Research Associate

2 weeks ago

Covington, United States CTI Full time
About the Role

We are seeking a highly skilled and experienced Clinical Research Associate to join our team at CTI. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials across various regions.

Key Responsibilities
  • Serve as the primary point of contact for assigned study sites, providing support and guidance as needed.
  • Conduct site visits, including pre-study, site initiation, interim monitoring, and close-out visits, to ensure compliance with regulatory requirements and study protocols.
  • Assist with study start-up activities, including feasibility assessments, pre-study activities, and site selection.
  • Collect, review, and track essential and regulatory documents, ensuring accuracy and completeness.
  • Participate in investigator, client, and project team meetings, providing updates and insights as required.
  • Develop and implement subject enrollment strategies for assigned study sites, ensuring timely and efficient recruitment.
  • Ensure proper storage, dispensation, and accountability of Investigational Product (IP) and trial-related materials.
  • Perform site management activities, providing ongoing updates on site status to Clinical Project Managers.
  • Conduct remote monitoring and complete related activities in accordance with study-specific Monitoring Plans.
  • Utilize systems and reports to track subject status, case report form (CRF) retrieval, and regulatory documents.
  • Assist with project-specific activities as a member of the Project Team.
  • Participate in the development of CRFs and other study-related documents.
  • Provide support to the Regulatory Affairs Study Start-up Team in the preparation and revision of documentation for submission to regulatory authorities.
  • Manage the Investigator Site File (ISF) and Trial Master File (TMF) for assigned study sites, ensuring compliance with SOPs and study-specific Monitoring Plans.
  • Identify and anticipate site issues, implementing corrective and preventive actions as needed.
  • Liaise with Clinical Data Management for data cleaning activities.
  • Serve as a mentor and trainer for CRAs, conducting training and assessment visits as required.
  • Function as a Lead CRA for assigned projects, providing guidance and support to team members.
Requirements
  • Excellent verbal and written communication skills.
  • Excellent organizational and time management skills.
  • Excellent critical thinking and decision-making skills, with the ability to identify challenges and potential risks.
  • Excellent collaboration, customer service, and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficient in the use of laptop computers and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), and electronic Data Capture (EDC).
  • Ability to understand complex medical terminology and procedures.
  • Ability to monitor complex indications.
  • Expert knowledge of ICH/GCP and all applicable regulatory requirements.
  • Ability to mentor and provide constructive feedback to lesser-experienced CRAs.
  • At least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.
  • 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 of clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources.
  • Previous experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO.

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