Senior CF CRA Consultant

4 weeks ago


San Jose, United States Cedent Consulting Full time
Summary:

We are seeking an experienced Senior Clinical Research Associate Consultant to support the clinical operations strategy for a CF program. As a proactive team player with strong expertise in clinical operations, you will work closely with Clinical Operations and cross-functional teams to drive the next wave of genetic medicines. This role requires substantial experience in rare diseases or genetic medicines, such as mRNA, gene therapy, or gene editing.

Key Responsibilities:
  1. Support the Clinical Operations Study team in ensuring timely and efficient trial initiation and completion.
  2. Assist with CRO activities, including site feasibility, qualification, initiation, and interim monitoring.
  3. Develop or assist in the creation of trial materials and activities for identifying rare disease patients.
  4. Collaborate with the Clinical Operations Program Lead, providing training to CRO and site staff.
  5. Track, monitor, and present key study performance metrics to the cross-functional team.
  6. Manage delegated trial processes from the Clinical Operations Study team.
  7. Review data listings for accuracy, oversee data discrepancy management, and provide training/retraining to site staff and CRAs as needed.
  8. Coordinate with CRO and vendors on start-up activities, including ethics submissions.
  9. Escalate issues promptly to the Clinical Operations Program Lead and Head of Clinical Operations.
  10. Foster strong working relationships with the study team and clinical trial sites.
  11. Travel as needed for site initiation and co-monitoring visits.
Qualifications:
  1. BS/BA with 4+ years of Clinical Operations experience in biotech/pharma across Phase 1-3 trials.
  2. Preferred experience in rare diseases or orphan drugs.
  3. Knowledge of ICH GCP guidelines and clinical monitoring procedures.
  4. Experience with clinical trial vendors, including CROs, imaging, home health, and patient recruitment.
  5. Highly responsive and proactive team player with a growth mindset for problem-solving.
  6. Strong organizational skills and the ability to manage multiple projects simultaneously.
  7. Excellent communication and interpersonal skills, effective in cross-functional and fast-paced environments.
  8. Creative problem-solving abilities, especially for rare disease programs.
  9. Ability to champion change in a dynamic, growing environment.

Department: Direct Clients
This is a full time position

#J-18808-Ljbffr

  • San Jose, United States Cedent Consulting Inc Full time

    We are seeking an experienced Senior Clinical Research Associate Consultant to support the clinical operations strategy for a CF program. As a proactive team player with strong expertise in clinical operations, you will work closely with Clinical Operations and cross-functional teams to drive the next wave of genetic medicines. This role requires substantial...


  • San Jose, California, United States Cedent Consulting Inc Full time

    Cedent Consulting Inc. is seeking a highly experienced Senior Clinical Research Associate Consultant to support the clinical operations strategy for our CF program.About UsWe are a leading consulting firm dedicated to providing expert guidance in clinical operations and rare diseases.Job DescriptionThis role requires substantial experience in rare diseases...


  • San Francisco, CA, United States Boston Consulting Group Full time

    Who We AreBoston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation-inspiring complex change, enabling organizations to grow, building...


  • San Jose, United States BSI Companies Full time

    Senior Physical Safety Consultant page is loaded Senior Physical Safety Consultant Apply locations San Jose Alameda time type Full time posted on Posted 30+ Days Ago job requisition id JR0013664 Great that you're thinking about a career with BSI!BSI Consulting Services is a trusted and agenda-shaping partner providing...


  • San Jose, California, United States True Partners Consulting Full time

    About the RoleWe are seeking a highly motivated and experienced Senior Tax Consultant to join our Research & Development team. As a key member of our team, you will be responsible for leading and managing multiple client service teams within your service line, providing outstanding client service, and achieving team goals.Key ResponsibilitiesAdvise clients...


  • San Jose, California, United States Aequor Allied Full time

    Job OverviewAequor Allied is seeking a Senior Occupational Therapist Consultant for a challenging travel assignment in San Jose, California.Key Responsibilities:Develop and implement effective occupational therapy programs for patients with diverse needs.Collaborate with interdisciplinary teams to ensure comprehensive care and optimal patient...


  • San Jose, United States BSI Full time

    Great that you're thinking about a career with BSI! BSI Consulting Services is a trusted and agenda-shaping partner providing ‘best practice’ technical, regulatory, and business expertise and intelligence for our clients’ most critical EHS, Supply Chain, and Digital risks and opportunities to achieve greater resilience, impact, and...

  • Tax Consultant

    4 days ago


    San Jose, California, United States Gpac Full time

    Tax Senior Role at GpacA reputable Public Accounting firm, Gpac, in the area is seeking a skilled Tax Senior to join their team. This stable and growing firm offers clients valuable knowledge and expertise in taxes and tax resolution. Due to recent growth, there is an opportunity for a Tax Senior to collaborate with a team of highly motivated staff.Key...


  • San Antonio, Texas, United States Talent Consultant Group Full time

    About Talent Consultant GroupTalent Consultant Group is a leading provider of innovative solutions for architectural projects. Our clients value our expertise and commitment to delivering high-quality results.Job OverviewWe are seeking an experienced Senior Architectural Project Manager to join our team in San Antonio, TX. This is a challenging opportunity...


  • San Jose, United States Xyant Services Full time

    Job Title: Senior Product Manager – Strategic ConsultingLocation: San Jose, CA-Locals PreferredLong term ContractKey Responsibilities:Product Management Mindset, Standards, and Methodologies: Develop, implement, and promote product management standards and best practices, such as defining product requirements, crafting product visions, and establishing key...


  • San Jose, California, United States COMERIT Full time

    Job DescriptionAt COMERIT, we are seeking a highly skilled Senior SAP Logistics Consultant to join our team. As an integral part of our organization, this role will play a crucial part in the dynamic and evolving needs of the SAP Logistics program.The ideal candidate will possess extensive knowledge of the Procure to Pay business process, Materials...


  • San Jose, United States Saxon Global Full time

    Role : DevOps/DevSecOps Senior Consultant Location : San Jose, CA Long term Contract role Job Description & Skill Requirement: Job Duties • Contribute to the development of the Pipeline Security Standard • Collaborate with Development teams to identify security tools to automate scans such as SAST/DAST/IAST. • Enhance existing CI/CD Processes...

  • Senior Consultant

    1 month ago


    San Francisco, United States BlueVoyant Full time

    Senior Consultant, Vendor Risk ManagementLocation: Remote, United States (East Coast Preferred)United States Citizenship RequiredPosition Overview:The Senior Consultant of Vendor Risk Management will spearhead the strategic delivery of comprehensive Vendor Risk Management Services. This role is pivotal in safeguarding our clients‘ supply chains by...


  • San Jose, United States Mindlance Full time

    Position Title: Senior Data Analyst/Data Warehouse Consultant Objective: This Resource will support data engineer and data analysis work for the Integrated Justice System and BI Platform Modernization projects. Typical Deliverables: Required Skills & Abilities: • 3+ years experience of Relational Data Modeling design and development of conceptual, logical,...


  • San Jose, California, United States Adobe Inc. Full time

    Transforming Customer ExperiencesWe are seeking an experienced Senior Technical Solutions Consultant to join our team at Adobe Inc. This role requires a deep understanding of enterprise architecture, proficiency in Adobe cloud solutions, and the ability to integrate and optimize data retention.About the RoleThe ideal candidate will have a proven track record...

  • Principal Consultant

    4 weeks ago


    San Jose, United States HCLTech Full time

    HCLTech is looking for a highly talented and self- motivated Industry Principal - Semiconductor to join in advancing the technological world through innovation and creativity.Job Title: Industry Principal - SemiconductorJob ID: 2532305Position Type: Full-TimeLocation: San Jose, CAResponsibilitiesStay abreast of the latest advancements in semiconductor...


  • San Jose, United States LanceSoft Full time

    Job Title: Senior Data Analyst/Data Warehouse Consultant Enter Job Description... 3+ years experience of Relational Data Modeling design and development of conceptual, logical, and physical data models User Interface to DB field mapping to support development teams •Report writing and Dashboard design, development, and transition. Peer Reviews and...


  • San Jose, United States LanceSoft Full time

    Job Title: Senior Data Analyst/Data Warehouse Consultant Enter Job Description... 3+ years experience of Relational Data Modeling design and development of conceptual, logical, and physical data models User Interface to DB field mapping to support development teams • Report writing and Dashboard design, development, and transition. Peer Reviews and...


  • San Jose, United States IT Shoulders, Inc. Remote Work Freelance Full time

    We are looking for a senior networking engineer for a contract job who will assess the existing Fortinet WiFi implementation at one of client and provide solutions for any issues. This 100% a remote work.Essential Duties & Responsibilities:Asses the existing Fortinet WiFi implementation.Provide complete review and report.Provide solutions & fixes for the...


  • San Francisco, California, United States Turner & Townsend Group Full time

    Senior Cost Consultant Job Description at Turner & TownsendWe are seeking an experienced Senior Cost Consultant to join our San Francisco Bay area team. As a Senior Cost Consultant, you will be responsible for managing the financial aspects of construction projects, ensuring accurate and timely cost reporting, and negotiating change orders.Key...