Consulting, Inc.
Senior Clinical Research Associate - Sr CRA
Consulting, Inc., Cincinnati, Ohio, United States, 45208
Senior Clinical Research Associate - Sr CRA
Job Category : Clinical Monitoring
Requisition Number : SENIO001585
Posted : October 15, 2025
Full-Time
Remote
Locations Showing 1 location
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit
www.ctifacts.com
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 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
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 Clinical Project Manager
Conduct remote monitoring and complete the related activities in accordance with 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 member of Project Team Monitoring Plan, etc.)
Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
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 in 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 an anticipate site issues and implement corrective 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 projects(s0
What You Bring
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 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
You need to be fully eligible to work in Brazil - (Bahia/Pernambuco/Rio Grande do Sul/Santa Catarina/São Pulo)
Proficiency in Spanish is considered an asset
Why CTI?
We support career progression – We have a structured mentoring program to provide the support you need to move forward
We value education and training – We provide tuition reimbursement, 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 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
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 – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
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 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
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
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an
@ctifacts.com
email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
#J-18808-Ljbffr
Requisition Number : SENIO001585
Posted : October 15, 2025
Full-Time
Remote
Locations Showing 1 location
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit
www.ctifacts.com
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 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
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 Clinical Project Manager
Conduct remote monitoring and complete the related activities in accordance with 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 member of Project Team Monitoring Plan, etc.)
Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
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 in 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 an anticipate site issues and implement corrective 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 projects(s0
What You Bring
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 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
You need to be fully eligible to work in Brazil - (Bahia/Pernambuco/Rio Grande do Sul/Santa Catarina/São Pulo)
Proficiency in Spanish is considered an asset
Why CTI?
We support career progression – We have a structured mentoring program to provide the support you need to move forward
We value education and training – We provide tuition reimbursement, 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 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
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 – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
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 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
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
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an
@ctifacts.com
email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
#J-18808-Ljbffr