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CTI Clinical Trial and Consulting Services · 21 hours ago

Senior Clinical Research Associate (level dependent on experience)

Covington, KY

Full-time

Hybrid

Mid, Senior Level

1+ years exp

CTI Clinical Trial and Consulting Services is focused on advancing medicine through clinical research. The Senior Clinical Research Associate will manage project activities associated with monitoring clinical research studies, ensuring adherence to regulatory guidelines and Standard Operating Procedures while serving as the main contact for assigned study sites.

BiotechnologyConsultingPharmaceutical

Growth Opportunities

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

Qualification

Clinical trial monitoringClinical Practice (GCP)Regulatory complianceBachelor's Degree in health fieldSite managementCommunication skillsTeam collaborationProblem-solving skills

Required

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