RJankowich Consulting, LLC
Empowering Clinical Trial Success
Why hire an expert Clinical Trial Consultant?
CROs often don't focus on the things that matter for efficient results.
Diligent site and vendor management are key to study success. Relationships matter!
Rachael is a highly skilled and dedicated professional with extensive experience in clinical trial development and operations. Rachael provides strategic guidance and operational support for small to mid-sized pharmaceutical and biotechnology companies. With years of proven results, Rachael helps clients navigate the complexities of clinical research and achieve fast results.
Ready to Elevate Your Clinical Trials?
Contact
RJankowich Consulting, LLC
Today
Whether you need assistance with clinical trial operations, protocol development, vendor management, or SOP and process development, I am here to help. Schedule a consultation to discuss your specific needs and discover how I can ensure your success.
Welcome to RJankowich Consulting, LLC
Your Partner in Clinical Trial Excellence
Rachael Jankowich, RN, MSN is an expert in effectively managing complex and innovative global clinical trials across multiple therapeutic areas. She has over 20 years of experience assisting in the planning and implementation of clinical research programs to drive successful drug development.
About
RJankowich Consulting, LLC specializes in providing comprehensive Clinical Operations and Development services for small to mid-sized pharmaceutical and biotechnology companies. With a wealth of experience and expertise in the field, Rachael is committed to helping her clients achieve success in the development and management of clinical trials.
Therapeutic Experience:
Rachael has a broad range of experience with small molecule and biologics
- Autoimmune Diseases (Dermatomyositis, NIU)
- Cardiovascular (CHF, CLI, HTN, LVSD)
- CNS (Pain, TBI, Epilepsy, Stroke)
- GI (Liver disease, Neoplasic polyps)
- Hematology (Anemia)
- Infectious Diseases (HBV, HCV)
- Oncology (CINV, Hem/Onc)
- Ophthalmology (AMD, NIU)
- Pediatrics (Epilepsy, LSD, NDO)
- Rare Diseases (DM, Inborn Errors of Metabolism, Lysosomal Storage Diseases, NIU)
- Respiratory (Asthma)
- Urology (BPH, OAB)
20+
Years of Experience
Proven
Results
Phase I to IV
Global Experience
Clinical Trial Operations Consulting
Providing strategic guidance and operational support to optimize the execution of clinical trials.
- A roll up my sleeves and get it done mentality
- A highly proactive thinker, anticipating and overcoming obstacles by implementing practical and timely solutions
- Expert in vendor oversight and ensuring compliance with study plans
- Deep experience across multiple functional areas with a collaborative, team-oriented mindset
- Exceptional organizational and problem-solving skills
- Strong skill base and knowledge of GCP and clinical research regulations
- Excellent written and verbal communication skills with an ability to express complex concepts
- Skillfully presents highly engaging study-specific training
Accelerated Study Start-Up
Assisting in the planning and implementation of clinical research programs to drive successful drug development.
- Identification, selection and management of quality sites
- Overall study timeline and budget management
- Timely site budget & contract review and negotiation
- Develop site relationships and support to ensure early productive screening/enrollment
- Provide individualized and study-specific best practices and lessons learned to ensure quality and reduce avoidable screen-failures
- Maintaining and developing KOL relationships
- Protocol development
- Vendor staff and site training
- Study plan review and finalization
- Vendor selection and oversight management
Clinical Trials Management
Overseeing all aspects of clinical trial management, ensuring efficient and compliant operations.
- Ensure efficient communication and clear expectations of sites and vendors
- Establish, review, and track key performance indicators (KPIs) and milestones
- Assure compliance with study timelines, scope, and budget
- Provide oversight and vendor feedback to ensure continued compliance with study plans, SOPs, and GCP
- Timely reviews of clinical data via eCRFs and listings to identify trends, outliers and to ensure high quality, completeness and study integrity
- Proactive reviews of deviations to ensure protocol compliance, identify issues, and implement swift solutions
Ensure Inspection Readiness with High Quality GCP Processes and SOPs
Experience creating and implementing robust and practical processes and standard operating procedures (SOPs) for Clinical Research.
©Copyright. All rights reserved.
We need your consent to load the translations
We use a third-party service to translate the website content that may collect data about your activity. Please review the details and accept the service to view the translations.