Regional Clinical Research Associate

Houston, TX
Full-Time
Part-Time
Internship
First Some Stuff on Us:

We recognize that employees look and feel different in every company, so it’s important to first describe the principles that will drive success in the role prior to talking about the specific responsibilities and tasks. These are: 
1. An obsessive focus on the customer 
2. Being accountable to the customer as if we were their own employee
3. Understanding that strategy is only as good as the execution - and vice versa 
4. Placing a high value on teamwork
5. People are at the heart of the product

In short, we want to build a big but small company.

PERKS:
Amazing culture: Happy, Helpful, Humble, Hungry.
Get to work in one of the fastest growing industries in TX – Life Sciences
Part of an amazing team
Flexible time off with pay
Opportunity for growth!

We know that diversity makes for the best problem-solving and creative thinking. We are dedicated to adding new perspectives to the team and encourage everyone to apply if your experience is close to what we are looking for.  

Equal
 Opportunity Employer: Proxima is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

job DESCRIPTION

As a Regional Clinical Research Associate, you will manage and monitor clinical sites to assure compliance with applicable regulatory requirements & Good Clinical Practices (GCPs).

A Day In the life
  • ‍Overnight travel 50%-90%, anywhere in the U.S.
  • Conduct site training, as needed
  • Conduct or attend site initiation visits
  • Perform on-site monitoring of clinical studies
  • Validate and collect study data
  • Manage enrollment issues, resolution of data queries, and site performance issues
  • Assist with collection of study metrics
  • Audit, manage and collect clinical regulatory documents
  • Ensure site compliance with regulatory requirements, Good Clinical Practices (GCPs), and with Proxima's client policies and procedures
  • Prepare clinical sites for FDA audits
  • Manage accountability of investigational product and documentation
  • Conduct study site close-out visits
  • Attendance at company meetings, and completion and proper submission of timesheets and training documentation
  • Adherence to Proxima or client Standard Operating Procedures (as applicable)
  • Professionally represent Proxima in business interactions
Must Have Knowledge and Skills
  • Must have strong interpersonal skills.  
  • Excellent oral and written communication skills.  
  • Ability to articulate issues.  
  • Self-management skills, including ability to multi-task.  
  • Attention to detail and accuracy in work.  
  • Strong problem solving and interpersonal skills.  
  • Keyboarding, word processing, and computer skills (proficiency using Microsoft Office).  
  • Ability to maintain confidentiality.

Nice to Have Knowledge and Skills
  • ‍BA, BS or Associate’s degree or equivalent in a scientific or healthcare field with a minimum of 12 months on-site monitoring experience.  
  • Must have thorough understanding of current GCPs and FDA regulations pertaining to clinical research.  
  • Familiarity with common medical terminology is required.
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