Clinical Research Nurse enhancing pediatric oncology care at Monash Children's Hospital. Collaborating with medical staff and managing patient flow for effective cancer treatment.
About the role
- Clinical Scientist in cell therapy responsible for design and execution of clinical trials. Collaborating with cross-functional teams and external partners to ensure study success.
Responsibilities
- Responsible for design and execution of assigned clinical trial activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Develop Protocol and ICF documents/amendments and present these to governance committee
- Conduct literature review and submit clinical documents to TMF
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- Monitor clinical data for specific trends
- Ensure CRF design aligns with data collection in collaboration with Data Management/Programming
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents
Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- 5 to 10 years of appropriate alternative experience (new entrance to pharma)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills (develop short range plans that are realistic and effective)
Benefits
- Wide variety of competitive benefits
- Services and programs that provide resources to pursue goals
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Senior Clinical Trial Manager overseeing site management and monitoring for biopharmaceutical solutions organization. Responsible for clinical monitoring, patient safety, and regulatory compliance in South Africa.
Associate HR Partner supporting employee operations at CPS Clinical Research Units. Providing HR guidance and managing employee relations in a clinical environment with on - site presence.
Clinical Research Study Assistant involved in Alzheimer's disease research collecting samples and data. Participating in study protocols and maintaining participant interactions.
Oncology Clinical Research Coordinator at WVU managing clinical trials and ensuring protocol compliance. Collaborating with research staff and healthcare providers while advocating for ethical participant care.
Clinical Research Coordinator supporting clinical research for pediatric care at Shriners Children’s. Ensuring compliance with research protocols and collaborating with clinical teams in Pasadena.
Clinical Research Coordinator managing aspects of clinical trials at Winship Cancer Institute. Handling data management, participant interface, and overseeing trial compliance in Atlanta.
Feasibility Manager at Novo Nordisk optimizing clinical trials through data analysis and strategic partnerships across South Africa. Driving site selection and operational readiness for impactful clinical development.
Clinical Research Coordinator managing overall coordination and implementation of clinical trials. Collaborating with investigators to ensure compliance with study protocols and maintaining accurate subject records.
Clinical Research Coordinator independently managing key aspects of clinical trials. Overseeing data management and ensuring compliance with study protocols and regulations.