Manager Research Administration QA and Regulatory

Description

Facility: UCHealth Poudre Valley Hospital (Fort Collins, CO)

Department: PVH Oncology Research

- Full-time

- Days

Bachelor’s degree is required

The UCHealth Research Administration Program is seeking an experienced Clinical Research Quality Assurance and Regulatory Compliance Manager. Position will be responsible for oversight of clinical research regulatory operations which include the processing of IRB submissions, IRB reporting, standard operating procedure development and maintenance, and training documentation development and maintenance.

Position will also support internal efforts for audit preparation and quality assurance to ensure that the clinical research executed maintains participant safety, data integrity, and protocol compliance. Position also responsible for process improvement measures, which includes identification of areas of improvement, process mapping, and implementation of new or modified processes. Preferred candidates will have experience in research compliance, processing IRB submission, and IRB reporting as well as the conduct of clinical research.

Successful candidates will be detail-oriented, have excellent written communication skills, be adept at learning new technologies, possess strong collaboration skills across a variety of stakeholders, and be knowledgeable about auditing/monitoring processes involved in the conduct of clinical research. Candidates must also possess knowledge of FDA and OHRP regulations and guidance’s and ICH guidelines.

Summary:

Manages the daily operations of the clinical research department.

Job Duties:

• Assists with developing departmental goals, standards, and objectives which directly support the strategic plan and vision of the organization.
• Manages staff including performance management, staff satisfaction, and conflict management. Performs and oversees scheduling, recruitment, payroll, and student engagements.
• Monitors departmental budgets, regulatory compliance, departmental contracts, and vendor relations. Determines and justifies needs for systems/equipment/supplies purchases, monitors usage, and oversees proper working order and/or stock supplies.
• Assesses the quality of services delivered and coordinates services with staff, the Institutional Review Board (IRB), other departments, and external agencies.
• 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:

• Bachelor’s degree in health or science related field
• 3 years of clinical research experience

The pay range for this position is: $39.32- $62.90 / 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 is a qualifying employer for the federal Public Service Loan Forgiveness (PSLF) program!
• 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.