Senior Clinical Research Associate (Level Dependent

Yel Solutions; Orlando (FL); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Associate to lead clinical trials and ensure compliance with regulatory standards. This role involves managing study sites, conducting monitoring visits, and supporting project teams. The ideal candidate will have a strong background in clinical trial monitoring and a relevant degree. Join a company that values career growth and work-life balance, and be part of a team that is committed to innovation and community engagement. If you are passionate about clinical research and want to make a difference, this opportunity is for you.

Qualifications

• 3+ years of clinical trial monitoring experience required.
• Bachelor's Degree in nursing, pharmacy, or health sciences preferred.

Responsibilities

• Serve as the main contact for assigned study sites and conduct site visits.
• Assist with study start-up activities and ensure compliance with regulations.
• Mentor/train CRAs and manage trial materials.

Skills

Clinical Trial Monitoring

Regulatory Compliance

Site Management

Project Management

Data Management

Education

Bachelor's Degree in Nursing

Bachelor's Degree in Pharmacy

Bachelor's Degree in Health/Natural Sciences

Job description

Senior Clinical Research Associate (Level Dependent)

CTI Clinical Trial Services, Inc

Senior Clinical Research Associate (Level dependent on experience)

Please submit your CV in English for the quickest review process!

Maintaining our company culture across all regions, especially with our remote employees, is incredibly important to our overall success. We hold weekly all-staff meetings where each department provides updates on studies or milestones. Employees can also join our CTI Cares committees, which support our culture and philanthropic efforts.

What You'll Do

1. Serve as the main CTI contact for assigned study sites
2. Conduct site visits (pre-study PSV, site initiation SIV, interim monitoring IMV, close-out COV) and complete site visit deliverables with quality and within timelines, adhering to Monitoring Plan, SOPs, ICH GCP, and regulatory requirements
3. Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection
4. Collect, review, and track essential/regulatory documents
5. Participate in and complete all required training
6. Participate in investigator, client, and project team meetings; may include presentations
7. Ensure proper storage, dispensation, and accountability of Investigational Product (IP) and trial materials
8. Perform site management activities and provide updates to the Clinical Project Manager
9. Conduct remote monitoring activities as per study-specific Monitoring Plan
10. Assist with project-specific activities within the Project Team
11. Translate, customize, and review study documents such as Patient Information Sheets, Informed Consent, and protocols
12. Support regulatory documentation submissions and follow-up until approval
13. Assist with contract negotiations, investigator payments, and tracking
14. Manage ISF and TMF for assigned study sites
15. Identify and address site issues, implementing corrective actions as needed
16. Liaise with Data Management for data cleaning activities
17. Serve as mentor/trainer for CRAs, including conducting training or assessments
18. Lead CRA for assigned projects

What You Bring

• At least 3 years of clinical trial monitoring experience or equivalent
• Bachelor's Degree or higher in nursing, pharmacy, health/natural sciences, or RN with Associate's Degree, or Nursing Diploma with 2+ years clinical nursing experience
• Experience in conducting clinical research in hospitals, pharmaceutical companies, or CROs

Why CTI?

At CTI, we recognize our people as our greatest asset. We support career growth, value education and training, and prioritize work-life balance. Our culture has been recognized with multiple awards, and we operate globally while maintaining local community connections. We are committed to investing in the future with technological advancements and sustained growth.