Senior Clinical Research Associate (level dependent on experience)

CTI Clinical Trial and Consulting Services•Covington, KY

12d•Hybrid

About The Position

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

Requirements

At least 1 year 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 an 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 a hospital setting, a pharmaceutical company, or a CRO
Demonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred

Responsibilities

Serve as the 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 the Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCP
Assist with 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
Create and implement subject enrollment strategies for assigned study sites
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 the Clinical Project Manager
Conduct remote monitoring and complete the related activities in accordance with study study-specific Monitoring Plan
Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP
Assist with project-specific activities as a member of the Project Team
May support in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.)
May support in the 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 the 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 on the evaluation process until approval is available. Provide regular updates to the Sponsor/ Client
Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary
Liaise with Clinical Data Management for data cleaning activities
Identify site issues and implement corrective actions or escalate as appropriate
Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
Where applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site payments