Job Information
University of Colorado Research and Regulatory Coordinator (Entry Senior Level) in Aurora, Colorado
Research and Regulatory Coordinator (Entry – Senior Level) - 33673 University Staff
Description
University of Colorado Anschutz Medical Campus
School of Medicine | Department of Medicine | Division of Pulmonary Sciences and Critical Care
Job Title: Research and Regulatory Coordinator (Entry – Senior Level)
Position: #00822947 – Requisition: #33673
Job Summary:
Research and Regulatory Coordinator
Note: This position is not anticipated to have any patient contact.
Key Responsibilities:
Independently prepare, develop, and submit Institutional Review Board (IRB), Biosafety, and Research and Development Committee documents such as protocols for initial submissions, protocol amendments, and continuing reviews for both human subject research protocols and bench studies.
Route Data Use Agreements, Material Transfer Agreements, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
Responsible for preparing, maintaining, and updating regulatory binders for review by internal or external monitoring/auditing groups.
Maintain current and accurate records of all applicable training and associated documents (CITI GCP, GLP, CVs, Licenses, etc.) for all research staff.
Serve as CAMM point of contact and coordinator for the development of new clinical protocols as well as point of contact for clinical trial sites and study sponsors to develop laboratory manuals, training materials, Standard Operating Procedures (SOP), and other material related to the collection, processing, storage, and intake of CAMM related biomarker samples collected in these studies.
Conduct training on sample collection methods, processing, and storage for clinical trial sites.
Work Location:
Hybrid
Why Join Us:
About the Division of Pulmonary Sciences and Critical Care Medicine
About the University of Colorado Anschutz Medical Campus
Position: # 00822947 – Requisition: #33673
Job Summary:
Research and Regulatory Coordinator
Note: This position is not anticipated to have any patient contact.
Key Responsibilities:
Independently prepare, develop, and submit Institutional Review Board (IRB), Biosafety, and Research and Development Committee documents such as protocols for initial submissions, protocol amendments, and continuing reviews for both human subject research protocols and bench studies.
Route Data Use Agreements, Material Transfer Agreements, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
Responsible for preparing, maintaining, and updating regulatory binders for review by internal or external monitoring/auditing groups.
Maintain current and accurate records of all applicable training and associated documents (CITI GCP, GLP, CVs, Licenses, etc.) for all research staff.
Serve as CAMM point of contact and coordinator for the development of new clinical protocols as well as point of contact for clinical trial sites and study sponsors to develop laboratory manuals, training materials, Standard Operating Procedures (SOP), and other material related to the collection, processing, storage, and intake of CAMM related biomarker samples collected in these studies.
Conduct training on sample collection methods, processing, and storage for clinical trial sites.
Work Location:
Hybrid
Why Join Us:
About the Division of Pulmonary Sciences and Critical Care Medicine
About the University of Colorado Anschutz Medical Campus
Job Summary:
Research and Regulatory Coordinator
Note: This position is not anticipated to have any patient contact.
Key Responsibilities:
Independently prepare, develop, and submit Institutional Review Board (IRB), Biosafety, and Research and Development Committee documents such as protocols for initial submissions, protocol amendments, and continuing reviews for both human subject research protocols and bench studies.
Route Data Use Agreements, Material Transfer Agreements, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
Responsible for preparing, maintaining, and updating regulatory binders for review by internal or external monitoring/auditing groups.
Maintain current and accurate records of all applicable training and associated documents (CITI GCP, GLP, CVs, Licenses, etc.) for all research staff.
Serve as CAMM point of contact and coordinator for the development of new clinical protocols as well as point of contact for clinical trial sites and study sponsors to develop laboratory manuals, training materials, Standard Operating Procedures (SOP), and other material related to the collection, processing, storage, and intake of CAMM related biomarker samples collected in these studies.
Conduct training on sample collection methods, processing, and storage for clinical trial sites.
Work Location:
Hybrid
Why Join Us:
About the Division of Pulmonary Sciences and Critical Care Medicine
About the University of Colorado Anschutz Medical Campus
Research and Regulatory Coordinator
Note: This position is not anticipated to have any patient contact.
Key Responsibilities:
Independently prepare, develop, and submit Institutional Review Board (IRB), Biosafety, and Research and Development Committee documents such as protocols for initial submissions, protocol amendments, and continuing reviews for both human subject research protocols and bench studies.
Route Data Use Agreements, Material Transfer Agreements, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
Responsible for preparing, maintaining, and updating regulatory binders for review by internal or external monitoring/auditing groups.
Maintain current and accurate records of all applicable training and associated documents (CITI GCP, GLP, CVs, Licenses, etc.) for all research staff.
Serve as CAMM point of contact and coordinator for the development of new clinical protocols as well as point of contact for clinical trial sites and study sponsors to develop laboratory manuals, training materials, Standard Operating Procedures (SOP), and other material related to the collection, processing, storage, and intake of CAMM related biomarker samples collected in these studies.
Conduct training on sample collection methods, processing, and storage for clinical trial sites.
Work Location:
Hybrid
Why Join Us:
About the Division of Pulmonary Sciences and Critical Care Medicine
About the University of Colorado Anschutz Medical Campus
Why work for the University?
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 (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://www.cu.edu/cu-careers/perks/cu-system)
Diversity and Equity:
Qualifications:
Minimum Qualifications:
Entry Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Intermediate Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
One (1) year clinical research or related experience.
Senior Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Two (2) years clinical research or related experience.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
Bachelor's degree in science or health related field.
One (1) to three (3) years of clinical research or related experience.
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Experience with Phase II-III clinical trials.
One (1) year of research regulatory compliance experience.
Knowledge, Skills, and Abilities:
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
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.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Knowledge of basic human anatomy, physiology, and medical terminology.
Demonstration of strong analytical and problem-solving skills.
Ability to function independently in a responsible and timely manner.
How to Apply:
Screening of Applications Begins:
June 15 th , 2024
Anticipated Pay Range:
or hiring range
Entry Level:
Intermediate Level:
Senior Level:
ADA Statement:
Background Check Statement:
Vaccination Statement:
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The Consortium for Applied Microbial Metrics (microbialmetrics.org) is a multi-institutional collaboration of investigators with a shared goal: to develop new pharmacodynamic (PD) markers that will accelerate pre-clinical drug development and human trials in mycobacterial diseases, including tuberculosis (TB) and non-tuberculosis lung disease. As a platform for cross-disciplinary collaborative innovation, the Consortium is developing practical new solutions to accelerate drug and regimen development for tuberculosis and other mycobacterial diseases. The Consortium is committed to the highest standards in research reproducibility and transparency. The Consortium is in a phase of rapid growth as key not-for-profit, federal and pharma stakeholders seek to utilize our novel drug-evaluation tools. The CAMM Molecular Core, under the guidance of PI Dr. Nichoals Walter and Associate Director for Operations is seeking a full-time whose primary responsibility is to serve as the primary point of contact for the CAMM Molecular Core to interface with clinical trial sites and manage the regulatory process of the CAMM Molecular Core lab for clinical protocols.
– this role is eligible for a hybrid schedule and as needed for in-person meetings; onsite location is at the Anschutz Medical Campus in Aurora, Colorado and schedule will be coordinated with supervisor.
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. 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 - https://apptrkr.com/get_redirect.php?id=5268247&targetURL=Research and Regulatory Coordinator (Entry – Senior Level)
The Consortium for Applied Microbial Metrics (microbialmetrics.org) is a multi-institutional collaboration of investigators with a shared goal: to develop new pharmacodynamic (PD) markers that will accelerate pre-clinical drug development and human trials in mycobacterial diseases, including tuberculosis (TB) and non-tuberculosis lung disease. As a platform for cross-disciplinary collaborative innovation, the Consortium is developing practical new solutions to accelerate drug and regimen development for tuberculosis and other mycobacterial diseases. The Consortium is committed to the highest standards in research reproducibility and transparency. The Consortium is in a phase of rapid growth as key not-for-profit, federal and pharma stakeholders seek to utilize our novel drug-evaluation tools. The CAMM Molecular Core, under the guidance of PI Dr. Nichoals Walter and Associate Director for Operations is seeking a full-time whose primary responsibility is to serve as the primary point of contact for the CAMM Molecular Core to interface with clinical trial sites and manage the regulatory process of the CAMM Molecular Core lab for clinical protocols.
– this role is eligible for a hybrid schedule and as needed for in-person meetings; onsite location is at the Anschutz Medical Campus in Aurora, Colorado and schedule will be coordinated with supervisor.
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. 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 - https://apptrkr.com/get_redirect.php?id=5268247&targetURL=00822947 – Requisition: #33673
The Consortium for Applied Microbial Metrics (microbialmetrics.org) is a multi-institutional collaboration of investigators with a shared goal: to develop new pharmacodynamic (PD) markers that will accelerate pre-clinical drug development and human trials in mycobacterial diseases, including tuberculosis (TB) and non-tuberculosis lung disease. As a platform for cross-disciplinary collaborative innovation, the Consortium is developing practical new solutions to accelerate drug and regimen development for tuberculosis and other mycobacterial diseases. The Consortium is committed to the highest standards in research reproducibility and transparency. The Consortium is in a phase of rapid growth as key not-for-profit, federal and pharma stakeholders seek to utilize our novel drug-evaluation tools. The CAMM Molecular Core, under the guidance of PI Dr. Nichoals Walter and Associate Director for Operations is seeking a full-time whose primary responsibility is to serve as the primary point of contact for the CAMM Molecular Core to interface with clinical trial sites and manage the regulatory process of the CAMM Molecular Core lab for clinical protocols.
– this role is eligible for a hybrid schedule and as needed for in-person meetings; onsite location is at the Anschutz Medical Campus in Aurora, Colorado and schedule will be coordinated with supervisor.
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. 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 - https://apptrkr.com/get_redirect.php?id=5268247&targetURL=whose primary responsibility is to serve as the primary point of contact for the CAMM Molecular Core to interface with clinical trial sites and manage the regulatory process of the CAMM Molecular Core lab for clinical protocols.
– this role is eligible for a hybrid schedule and as needed for in-person meetings; onsite location is at the Anschutz Medical Campus in Aurora, Colorado and schedule will be coordinated with supervisor.
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. 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 (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://www.uchealth.org/locations/uchealth-university-of-colorado-hospital-uch/) and Children's Hospital Colorado (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://www.childrenscolorado.org/locations/anschutz-medical-campus-aurora/) - 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 (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://www.cuanschutz.edu/) . We have AMAZING Benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including: To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://www.cu.edu/employee-services/benefits-wellness)
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.
For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position. 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address. Questions should be directed to: Chantal Underkofler, chantal.underkofler@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=chantal.underkofler@cuanschutz.edu)
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by . Those who do not apply by this date may or may not be considered.
The starting salary range () for this position has been established as: $47,743 - $60,729 $51,956 - $66,088 $56,169 - $71,447 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 (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=http://www.cu.edu/node/153125)
The University will provide reasonable accommodation 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 hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=hr.adacoordinator@cuanschutz.edu) .
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.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .
Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20219 - SOM-MED-PUL GENERAL OPERATIONS : Full-time : May 17, 2024 : Ongoing Posting Contact Name: Chantal Underkofler Posting Contact Email: chantal.underkofler@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5268247&targetURL=chantal.underkofler@cuanschutz.edu) Position Number: 00822947jeid-59575a522962514781e5600328304b51
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.