Independent Contractor - Clinical Research Regulatory and Ops Admin

Cardiovascular Associates of America; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

Join a pioneering organization transforming cardiovascular care as an Independent Contractor for Clinical Research Regulatory and Ops Admin. In this role, you will ensure compliance, train staff, and set up new processes across trial locations, playing a key role in the organization’s pioneering efforts. This exciting remote position offers potential career growth and the opportunity to impact cardiovascular research significantly.

Qualifications

• Extensive experience in clinical trial management and regulatory compliance required.
• Knowledgeable in ICH and GCP standards.
• Experience training and mentoring staff.

Responsibilities

• Lead regulatory compliance for clinical trials across multiple sites.
• Train and develop new clinical trial staff.
• Manage study start-up processes and regulatory submissions.

Skills

Regulatory Compliance

Clinical Trial Management

Staff Training

Communication

Organizational Skills

Problem Solving

Education

Bachelor's degree in Life Sciences

Certification in Clinical Research

Tools

Regulatory Affairs Software

Trial Management Systems

Job description

Independent 1099 Contractor - Clinical Research Regulatory and Ops Admin

Contractor – role up to four months or more with the potential for permanent placement,

Position Overview:
Are you an ambitious and innovative professional ready to take on a pioneering role? Experienced and motivated Independent Contractor to work as a Clinical Research – Regulatory and Operations Administrator.

This is a temporary contract position and not an employee role. However, the role may become a contract-to-hire opportunity, with the potential to transition to a full-time W-2 employee based on performance and business needs.

Join CVAUSA as the inaugural Research Regulatory Staff member and be at the forefront of revolutionizing cardiovascular care.

This exciting remote opportunity will see you supporting, training, and overseeing the growth of clinical trial staff across multiple locations and practices. You'll play a key role in setting up new processes and procedures that will help drive the success of our clinical trials while ensuring they comply with the highest regulatory standards, including ICH and GCP guidelines.

As the inaugural incumbent in this position, you’ll be a driving force behind establishing the foundation for our growing network of clinical trial locations. This is your opportunity to make a lasting impact and help shape the future of cardiovascular research.

Key Responsibilities:

• Regulatory Leadership: Be the founding regulatory expert supporting multiple clinical trial locations and practices, ensuring compliance with ICH and GCP standards. You will lead regulatory milestones from the very start, guiding studies from initiation to completion.
  
• Training and Staff Growth: Play an instrumental role in building out and training new staff across various locations. You'll oversee their development and ensure they’re equipped with the tools and knowledge to thrive in a rapidly evolving clinical trial environment.
  
• Study Start-Up Excellence:Lead the study start-up process across multiple sites, preparing, submitting, and managing regulatory documents, including IRB submissions and informed consents. Your proactive approach will ensure all studies are launched smoothly and on time.

• Process Development and Implementation: Set up new processes and procedures that streamline clinical trial operations across locations, ensuring a consistent, compliant, and efficient workflow as the trial network grows.

• Collaborative Communication: Maintain strong communication across internal teams, sponsors, and external partners. Ensure everyone is aligned on regulatory requirements, timelines, and project goals.
  
• Compliance Monitoring and Auditing: Lead internal audits and support external regulatory inspections, ensuring that all trials meet the highest standards for compliance.
  
• Innovative Problem Solving: Address regulatory challenges with a creative, solutions-oriented mindset. You’ll be essential in developing strategies to keep trials progressing smoothly, even when facing obstacles.
  
• Remote Collaboration: Work remotely while collaborating virtually with cross-functional teams, leading the development of a unified approach to clinical trials across locations.

Required Qualifications:

• Bachelor's degree in Life Sciences, Healthcare, Regulatory Affairs, or a related field.
  
• Extensive experience in research administration, clinical trial management, and regulatory management
  
• In-depth knowledge of ICH guidelines, GCP regulations, and applicable regulatory requirements.
  
• Proven track record of leading successful study start-ups, regulatory compliance, and maintaining timelines.
  
• Experience training and mentoring staff to ensure their growth and success.
  
• Exceptional communication skills with the ability to lead teams and work collaboratively with external partners and internal stakeholders.
  
• Strong organizational skills and attention to detail in managing multiple projects and priorities.
  
• A self-starter with a proactive and innovative mindset, eager to shape and drive success in a remote and growing organization.

Preferred Qualifications:

• Experience using regulatory affairs software and trial management systems.
  
• A passion for driving change and contributing to a rapidly growing organization.
  
• Certification in Clinical Research (e.g., CCRA, ACRP, SOCRA).

MUST HAVE:
Clinical Trial Experience

Compensation:
Compensation for this position will be based on project scope, experience, and other factors.

Why CVAUSA?

At CVAUSA, we're transforming the future of cardiovascular care through value-based models. As a physician-led organization, we support and empower our teams to innovate and grow. This is an exciting opportunity to be a foundational part of our expanding network, directly impacting patient outcomes and advancing cardiovascular research across the country. Join us and make your mark as the first Research Regulatory Staff member!