Research Regulatory Specialist

Description

The UCHealth Research Administration Program in Southern Colorado is seeking a Research Regulatory Specialist. This position will primarily support Cardiac, Vascular, Trauma and Neurology research efforts in Colorado Springs, CO. As an administrative role typical work days are 8 hours, Monday-Friday, at Memorial Hospital Central, which means no weekends, no major holidays, no nights, and no on-call requirements. Some remote work possible with prior management approval.

Successful candidates will be detail-oriented critical thinkers with a high-level of personal integrity, be adept at learning new technologies, and have excellent communication, interpersonal and collaboration skills. Must be able to work in a fast-paced environment and take appropriate action with minimal supervision. Candidates should possess at least a basic understanding of FDA and OHRP regulation and guidance and ICH guidelines.

• Minimum Required Education: Bachelor's degree.
  
• Minimum Experience: 3 years of relevant experience.

Summary:

Develops and submits Study Institutional Review Board (IRB) documents for initial submissions, protocol amendments, and continuing reviews.

Responsibilities:

• Prepares, maintains and updates regulatory binders for review by internal or external monitoring/auditing groups. Works with auditors and monitors to discuss regulatory issues at each visit.
• Maintains FDA and GCP required regulatory documentation for individual site, studies, and sponsors.
• Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements. Works closely with sponsors and study teams on the preparation of regulatory documents and relevant regulatory issues
• Ensures all regulatory documentation is compliant with Standard Operating Procedures (SOP's) for format and content.

Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action.

Requirements:

• Minimum Required Education: Bachelor's degree.
  
• Minimum Experience: 3 years of relevant experience.

The pay range for this position is: $22.80 - $29.64 / hour. Pay is dependent on applicant's relevant experience.

UCHealth offers a Five Year Incentive Bonus to recognize employee's contributions to our success in quality, patient experience, organizational growth, financial goals, and tenure with UCHealth. The bonus accumulates annually each October and is paid out in October following completion of five years' employment.

UCHealth offers their employees a competitive and comprehensive total rewards package:

• Full medical, dental and vision coverage
• Retirement plans to include pension plan and 403(b) matching
• Paid time off.  Start your employment at UCHealth with PTO in your bank
• Employer-paid life and disability insurance with additional buy-up coverage options
• Tuition and continuing education reimbursement
• Wellness benefits
• 5 year incentive bonus
• Full suite of voluntary benefits such as identity theft protection and pet insurance
• Education benefits for employees, including the opportunity to be eligible for 100% of tuition, books and fees paid for by UCHealth for specific educational degrees. Other programs may also qualify for up to $5,250 pre-paid by UCHealth or in the form of tuition reimbursement each calendar year
  

Loan Repayment:

UCHealth provides employees with free assistance navigating the PSLF program to submit their federal student loans for forgiveness through Savi.

At UCHealth, we do things differently

We believe in something different: a focus on the individuality of every person. In big ways and small, we exist to improve the extraordinary lives of all those we serve. As Colorado's largest and most innovative health care system, we as a team deliver on the commitment to provide the best possible experience for our patients and their families. We foster a true human connection and give people the freedom to live extraordinary lives. A career at UCHealth is more than a job, it's a passion.

Going beyond quality requires the perfect balance of talent, integrity, drive and intellectual curiosity. We are looking for individuals who recognize, like us, that the world of medicine is ever-changing and are motivated to do what is right, not what is easy. We support creativity and curiosity so that each of us can find the extraordinary qualities within ourselves. At UCHealth, we'll do everything in our power to make sure you grow and have a meaningful career. There's no limits to your potential here.

Be Extraordinary. Join Us Today!

UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an affirmative action/equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individual's race, creed, color, religion, gender, national origin or ancestry, age, mental or physical disability, sexual orientation, gender identity, transgender status, genetic information or veteran status. UCHealth does not discriminate against any "qualified applicant with a disability" as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization.