Role Overview
As a CRA II - Sponsor Dedicated, you will play a key role in managing clinical trial operations across Oncology and Neurology studies. This home-based position requires regular travel—up to 75%—to investigator sites, where you will conduct monitoring visits and support end-to-end trial execution from site qualification through close-out.
Key Responsibilities
- Conduct site qualification, initiation, interim, and close-out visits, either on-site or remotely
- Ensure adherence to regulatory standards, including ICH-GCP, GPP, and applicable local guidelines
- Evaluate site performance and recommend actions to maintain protocol compliance
- Escalate critical issues promptly and contribute to corrective action planning
- Verify informed consent procedures and protect patient confidentiality
- Review source documents and medical records to confirm data accuracy in case report forms
- Apply query resolution techniques to resolve discrepancies within established timelines
- Support electronic data capture compliance and maintain data tracking systems
- Monitor investigational product handling, including storage, dispensing, and accountability
- Assess risks related to randomization and blinded study components
- Ensure proper labeling, importation, and return of investigational products per protocol
- Review and reconcile Investigator Site Files with the Trial Master File
- Confirm sites archive essential documents in line with local regulations
- Document monitoring activities through trip reports, letters, and communication logs
- Support patient recruitment and retention initiatives using local insights
- Track study progress, action items, and site-level deliverables
- Collaborate with central monitoring teams and act as a liaison with site staff
- Train site personnel and junior staff on compliance and study requirements
- Attend investigator meetings, sponsor sessions, and global team huddles
- Prepare for audits and support follow-up activities to maintain readiness
- Stay current with ICH/GCP standards, company processes, and project-specific training
- For late-phase real-world studies, serve as a Site Management Associate II and support chart abstraction and data collection
- Identify potential new sites based on regional treatment patterns and HCP networks
- Flag out-of-scope activities to project leadership
Qualifications
Candidates should hold a Bachelor’s degree or RN in a related discipline, or an equivalent combination of education and experience. Familiarity with Good Clinical Practice and regulatory frameworks is essential. Strong computer literacy and adaptability to new technologies are required. Excellent interpersonal and communication skills are critical for success. The role demands up to 75% travel, so candidates must be flexible and organized.
Work Environment
This is a hybrid, home-based position based in the Orlando, FL area, with frequent travel to clinical sites. You will work within a global network of professionals, supported by structured training and career development resources.
Compensation & Benefits
The salary range for this role is $70,100 to $126,100, with additional opportunities for performance-based bonuses and commissions. Benefits include a 401(k) company match, eligibility for the Employee Stock Purchase Plan, comprehensive health coverage (medical, dental, vision), and flexible paid time off. A company car or allowance is provided to support travel needs.
Company Culture
The organization values inclusion, innovation, and impact. Team members are encouraged to contribute ideas, collaborate globally, and drive solutions for complex healthcare challenges. With a focus on professional growth and authentic engagement, the culture supports individuals in making meaningful contributions to patient outcomes.
