Company Info for bloodworksnw.org | IcebreakerMembers
Accomplished Clinical Reseach and Trial Specialist with more than ten years' of Apheresis and Immunology experience managing, conducting, consulting and coordinating on clinical trials (drugs and devices) with hospitals as well as pharmaceutical and CRO companies. Adept at managing clinical studies, data, sponsors, organization collaboration, staff training, and protocols for diverse medical areas. A strong leader able to handle complex projects with large teams and participant groups. Armed with certifications in CRC, GCP, Biomedical Research, Human Research, Clinical Research and Information Privacy Security in addition to the doctorate in medicine. Multilingual United States Citizen fluent in English, Hindi, Punjabi, and with knowledge of French and German. Available to take up a challenging assignment which is clinically and academically motivating in an ideal clinical research organization.
10+ years Experience
Doctor of Medicine, Sr. Consultant Apheresis, and Nephrology
Clinical Research, Clinical Trial, Clinical Data Management
Clinical Immunology
Consultant - Project Management, IT
Specialties:
Apheresis, Nephrology, Internal Medicine
Oncology
CVS
CNS
Hospital & Healthcare
Medical Liaison
Medical Education
IT
SKILLS:
Clinical Research
Clinical Trials: Drugs and Devices
CDM
Project Management
Planning
FDA, ICH, GCP, GXP Compliance
Negotiating
Conducting
Monitoring: SQV, SIV, IMV, RMV, COVs
Risk-Based Monitoring
Reporting on trials: MVR on TMF and CTMS
Protocol development and SOP Development
Preparing informed consent materials
Contracting
Training and Recruiting
Healthcare Management
Quality assurance
Study document management
Collaboration with CPA, CTMA, CPMS
Surveillance + evaluation
Assisting regulatory submissions
Clinical + Technical Support
Supporting publication work
Interface with Team
Word, PowerPoint, Excel
