Principal Clinical Research Associate

CTI Clinical Trial Services; São Paulo; On-site; BRL 180,000 - 300,000; Full time

Job summary

CTI Clinical Trial Services in Sao Paulo, Brazil, is seeking a Principal Clinical Research Associate. You will be the primary CTI contact for assigned study sites, conduct site visits (PSV, SIV, IMV, COV) and ensure regulatory deliverables meet ICH-GCP standards.

You will also help with start-up activities and site payments. Ideal candidates bring 8 years of monitoring experience and a Bachelor’s degree in allied health or equivalent, with prior CRO/hospital or pharma exposure.

Qualifications

• 8 years of clinical trial monitoring experience or equivalent
• Bachelor's Degree or higher in allied health field such as nursing, pharmacy, health/natural science
• Experience in hospital, pharmaceutical company, or CRO settings

Responsibilities

• Serve as main CTI contact for assigned study sites
• Conduct PSV, SIV, IMV, and COV site visits and deliverables
• Collect, review and track essential/regulatory documents
• Participate in investigator, client and project team meetings
• Create enrollment strategies and oversee IP storage and accountability
• Manage ISF and TMF per SOPs and Monitoring Plans
• Mentor/train CRAs and act as Lead CRA when required
• Identify and propose process improvements and provide therapeutic area expertise

Skills

Site monitoring

Regulatory knowledge

ICH-GCP/compliance

Study coordination

Vendor/stakeholder liaison

Education

Bachelor's degree in allied health

Nursing diploma/degree alternative

Healthcare/clinical background

Job description

Position: Principal Clinical Research Associate

Location: Sao Paulo, Brazil

Job Id:156-22; 313-22

# of Openings:4

Principal Clinical Research Associate

Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.

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 or oversee 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 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
• 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 or oversee the 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 and anticipate site issues and implement corrective and preventive 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 project(s)
• Identify and propose process improvements
• Provide therapeutic area expertise to team members

What You Bring

• 8 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

Why CTI?

• 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 from 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