School of Medicine | Department of Medicine | Division of Pulmonary Sciences and Critical Care
Job Title: CLIA General Supervisor (Research Services Regulatory Compliance Program Manager)
Position: #00824474 – Requisition: #34137
Job Summary:
This position will fulfill the role of General Supervisor under CLIA. Under the general direction of the Principal Investigator and the Laboratory Director, the General Supervisor will be responsible for the day-to-day supervision and oversight of the laboratory operation and personnel performing testing and reporting test results in accordance with the CAMM Molecular Core laboratory’s CLIA quality management system. The General Supervisor will be part of a dynamic, multi-disciplinary team responsible for quality assurance, client services, data management and regulatory matters. The candidate must be willing to roll up their sleeves, collaborate and have fun.
Key Responsibilities:
Responsible for providing the day-to-day supervision of high complexity test performance by testing personnel in the laboratory per 42 CFR 493.1461.
Identifies the need for policies, procedures and educational materials as they relate to laboratory and research activities and regulations.
Monitor, report, and track all non-conforming events and protocol deviations and ensure that remedial actions are taken whenever test systems deviate from performance specifications and all applicable events are reported to the appropriate body per regulatory and sponsor requirements.
Provides standardize education and training to staff across CAMM Molecular Core staff.
Monitor, report, and track all non-conforming events and protocol deviations and ensure that remedial actions are taken whenever test systems deviate from performance specifications and all applicable events are reported to the appropriate body per regulatory and sponsor requirements.
Develops corrective and preventative action plans (CAPA) in response to audits and internal quality control reviews.
Helps guide managers and employees on problem solving, workflow resolution, and regulatory compliance.
Work Location:
Onsite – this role is expected to work onsite at the Anschutz Medical Campus in Aurora, Colorado.
Why Join Us:
About the Division of Pulmonary Sciences and Critical Care Medicine
Thank you for your interest in the Division of Pulmonary Sciences and Critical Care Medicine at the University of Colorado! Our over 140 faculty are located across four sites: the University of Colorado Anschutz Medical Campus, National Jewish Health, Denver Health, and the VA Eastern Colorado Health Care System.
We are very proud of our long and illustrious history. Many seminal discoveries in pulmonary and critical care medicine occurred here in Denver, including advances in tuberculosis, interstitial lung disease, airway disease, cancer, and critical care. Many of our former trainees have taken leadership roles in academic medicine, including Division and Department Chairs, Deans, and American Thoracic Society Presidents.
We continue to enhance all aspects of our division and training program, and as a result, we have seen tremendous and sustained growth. The clinical practice sites have built new hospitals, and there are multiple new research buildings across the campuses. We have been fortunate to recruit tremendous new faculty members while retaining many of our former trainees.
About The University Of Colorado Anschutz Medical Campus
The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu.
Why work for the University?
We have AMAZING Benefits and offer exceptional amounts of holiday, vacation, and sick leave!
The University of Colorado offers an excellent benefits package including:
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22 (maximum accrual 352 hours)
Sick Days: 15 (unlimited maximum accrual)
Holiday Days: 10
Tuition Benefit: Employees have access to this the benefit on all CU campuses
ECO Pass: RTD Bus and light rail service
Additional Perks & Programs: Click here to access a few more Perks and Programs
To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.
Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum Qualifications:
A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis, but not for the specific experience.
Four (4) years of experience working with clinical research.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
A master’s degree in chemical, physical or biological sciences from an accredited institution, and subsequent to graduation, have the years of training/experience in high complexity testing commensurate with degree and associated CLIA requirements.
Three (3) or more years of experience in high complexity molecular testing in a CLIA lab.
Five (5) or more years of experience in a molecular testing lab.
Previous experience as a General Supervisor under CLIA.
Previous management experience.
Prior experience with molecular diagnostics (amplification-based assays).
Experience with CLIA and CO State regulatory requirements.
Knowledge, Skills, and Abilities:
Solid understanding of IRB (Western IRB and COMIRB) processes, ICH/GCP, CFR, and other regulatory requirements related to the conduct of clinical trials.
Ability to work with a great attention to detail within a larger team and work with colleagues in a confidential and professional manner.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Ability to be meticulous and detail oriented.
Strong written and oral communication skills.
Must be enthusiastic to work in a startup environment, with a positive attitude and a high tolerance for ambiguity.
How to Apply:
or full consideration, please submit the following document(s):
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
Curriculum vitae / Resume
Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.
Questions should be directed to: Chantal Underkofler, [email protected]
Screening of Applications Begins:
Immediately and continues until July 13th, 2024.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as $71,995 – $91,577.
The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator: http://www.cu.edu/node/153125
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected] .
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.