Clinical Trials Lead Consultant - SME

IBM; Durham (NC); Remote; USD 80,000 - 120,000; Full time

Job summary

A forward-thinking company is seeking a Clinical Trials Lead Consultant to drive impactful oncology research initiatives. In this role, you'll manage research studies, ensuring compliance with GCP and HIPAA regulations while collaborating with stakeholders to enhance processes. Your expertise in clinical trials management will be pivotal in advancing oncology care for veterans. This position offers a unique opportunity to contribute to meaningful change in the healthcare landscape. Join a culture that values innovation and long-term career growth, where your contributions can lead to groundbreaking advancements in clinical research.

Qualifications

• Proven experience in clinical trials management or research coordination.
• Strong knowledge of GCP and HIPAA regulations.

Responsibilities

• Manage initiation of research studies, including contracting and study setup.
• Develop recruitment materials to support enrollment efforts.

Skills

Clinical Trials Management

GCP Regulations

HIPAA Compliance

Organizational Skills

Problem-Solving Skills

Communication Skills

Education

Doctorate Degree

Job description

Join to apply for the Clinical Trials Lead Consultant - SME role at IBM

Introduction
A career in IBM Consulting is rooted in long-term relationships and close collaboration with clients across the globe.
You'll work with visionaries across multiple industries to improve the hybrid cloud and AI journey for the most innovative and valuable companies in the world. Your ability to accelerate impact and make meaningful change for your clients is enabled by our strategic partner ecosystem and our robust technology platforms across the IBM portfolio, including Software and Red Hat.
Curiosity and a constant quest for knowledge serve as the foundation to success in IBM Consulting. In your role, you'll be encouraged to challenge the norm, investigate ideas outside of your role, and come up with creative solutions resulting in groundbreaking impact for a wide network of clients. Our culture of evolution and empathy centers on long-term career growth and development opportunities in an environment that embraces innovation.

Your Unique Skills And Experience
Your role and responsibilities
We are seeking a Clinical Trials Lead Consultant to support the VA National Oncology Program by providing subject matter expertise and driving clinical trial initiatives on a key contract. This role plays a critical part in ensuring the successful execution of research studies and advancing oncology care for veterans.

Key Responsibilities

1. Study Preparation: Manage the initiation of research studies, including contracting and study setup. Prepare and submit Institutional Review Board (IRB) applications and other relevant documentation.
2. Patient Screening and Recruitment: Identify and screen eligible study participants, and develop recruitment materials to support enrollment efforts.
3. Data Management and Compliance: Assist with study data collection and ensure proper documentation in adherence to Good Clinical Practices (GCP) and HIPAA regulations.
4. Workflow and Process Development: Create and implement study execution workflows and Standard Operating Procedures (SOPs). Identify process gaps within VA operations and documentation and propose solutions for improvement.
5. Stakeholder Collaboration: Facilitate communication with stakeholders, provide regular progress reports, and ensure alignment across teams to achieve study objectives.

Qualifications

• Proven experience in clinical trials management or research coordination.
• Strong knowledge of GCP and HIPAA regulations.
• Experience with IRB submissions and contracting processes.
• Exceptional organizational and problem-solving skills to identify and address gaps in workflows and documentation.
• Effective communication and collaboration skills to engage stakeholders and report on progress.

This role offers the opportunity to contribute to impactful oncology research while improving processes and workflows within the VA system. If you are passionate about clinical research and thrive in a leadership role, we encourage you to apply!

This Job can be performed from anywhere in the US

Preferred Education
Doctorate Degree

Required Technical And Professional Expertise
Clinical Trials Lead Consultant - SME for this requirement must demonstrate the following:

• Experience as a clinical trials physician or nurse (advanced degree candidates considered)
• Experience conducting oncology or related clinical trials (5 years minimum)
• Experience serving as an expert for a research team
• Experience working on multi-institutional or national level projects
• Experience working virtually or leading projects using innovative technology i.e. telehealth.
• Experience in clinical research including regulatory, data management, coordination, fiscal, project management
• Comprehensive understanding of oncology or clinical continuum of care
• Ability to obtain and maintain a Federal security clearance with the US government

Preferred Technical And Professional Experience

• Highly motivated, with clear evidence of drive and significant achievements
• Drive to overcome challenging or difficult obstacles and look for ways to improve results
• Ability to handle multiple tasks concurrently and meet deadlines, while maintaining focus in an environment with conflicting demands

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• IT Services and IT Consulting

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