McKesson is looking for a Clinical Research Assistant II to provide essential support for clinical trial operations. You will work closely with the Clinical Research Nurse, Clinical Research Coordinator, and Data/Regulatory Coordinator to advance our mission-driven focus on transforming care through clinical excellence.
What You'll Do
- Assist in screening, enrolling, and following study subjects, ensuring protocol compliance and close monitoring.
- Perform data collection, manage regulatory requirements, complete study-specific case report forms, and submit adverse experience reports.
- Schedule patient consultations, diagnostic tests, and future appointments with physicians.
- Collect and process specimens for research purposes.
- Maintain accurate records including signed informed consent forms, source documentation, and regulatory documents.
- Enter and resolve queries for data in electronic data capture systems for assigned clinical trials.
- Investigate and report protocol deviations, and assist in SAE reporting and tracking.
- Create and maintain patient visit tracking spreadsheets and manage imaging requests per guidelines.
- Report required metrics to the leadership team and work to meet industry trial data deadlines.
- Establish a positive relationship with Clinical Research Associates (CRAs) and assist in managing monitor visits.
- Maintain FDA and GCP required regulatory documentation, ensuring compliance with local Standard Operating Procedures (SOPs).
- Triage site requests for regulatory support and provide site-level regulatory support for study start-up and maintenance.
- Assist other colleagues as needed and help maintain document management for regulatory files.
What We're Looking For
- Knowledge of GCP and GMP.
- Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, Microsoft Office (Outlook, Word, Excel, and PowerPoint) and SharePoint.
Nice to Have
- Knowledge of scientific, medical, and regulatory terms.
- One year of clinical experience.
- One year of research and/or oncology experience.
- SOCRA or ACRP certification.
Technical Stack
- Clinical trial databases
- Electronic data capture systems
- Microsoft Office (Outlook, Word, Excel, PowerPoint)
- SharePoint
Team & Environment
You will provide daily support to the Clinical Research Nurse, Clinical Research Coordinator (CRC), and Data/Regulatory Coordinator.
Benefits & Compensation
- A Total Rewards package with comprehensive benefits to support physical, mental, and financial well-being.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
