Clinical Science Research Coordinator Perinatal Pediatric Team - 24773 University Staff

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, Department of Pediatrics, Section of Infectious Disease, Children's Hospital Immunodeficiency Program (CHIP)

Official Title: Research Services Clinical Science Professional (Open Rank)

Working Title: Clinical Science Research Coordinator Perinatal Pediatric Team (Open Rank: Entry-Senior Level)

Position #00794179 – Requisition #24773

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

Anschutz Campus – Accommodations may be granted for medical or religious reasons. Denver Campus - - Exemptions may potentially be approved for medical, religious, or personal reasons. Consolidated/Central Services Administration – Accommodations may be granted for medical or religious reasons.

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

The Department of Pediatrics' Section of Infectious Disease has an opening for a full-time University Staff (unclassified) Clinical Science Research Coordinator Perinatal Pediatric Team (Open Rank: Entry-Senior Level) for the Children's Hospital Immunodeficiency Program (CHIP).

Jobs in the Research Services career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal, and training.

Professionals at all levels are responsible for exercising discretion, analytical skill, personal accountability, and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying, and sharing knowledge directly related to a professional field. At the entry level, duties are limited in scope and are performed with guidance and direction from other professionals and are performed in a training and development capacity. At the intermediate level, duties are less limited in scope and are performed independently with occasional guidance and direction from other professionals. Work at the senior level is performed fully independently.

Nature of Work

Clinical Science Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.

At Children's Hospital Immunodeficiency Program (CHIP) we have a clear vision to be a place where a diverse mix of talented people want to come and stay and do their best work. We pride ourselves on bringing the best medical care and research to the patients we serve to improve the health of individuals. We endeavor to demonstrate CHIP's dedication to promoting diversity, multiculturalism, and inclusion in all our care. CHIP is a study site for multi-center clinical trials from the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT), the Pediatric AIDS Cohort Study (PHACS) and the Adolescent Trials Network (ATN) and Covid Prevention Network (CoVPN).

Examples of Duties Performed

Entry Level:

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• Adhere to research regulatory standards
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order

Intermediate Level, all above and:

• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members

Senior Level, all above and:

• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
• Serve as a resource and participate in study initiation and close out duties

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Salary and Benefits

The salary range for this position has been established at:

Entry: $44,403 - 56,481

Intermediate: $48,321 – 61,464

Senior: $52,239 – 66,448

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty, and training.

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 is not eligible for overtime compensation.

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.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity

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 hr.adacoordinator@ucdenver.edu​.

The University of Colorado Denver | 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 and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | 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.


Qualifications
Minimum Qualifications

Entry Level

• Bachelor's degree in psychology, neuroscience, life sciences, physiology, or other related 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 psychology, neuroscience, life sciences, physiology, or other related 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 psychology, neuroscience, life sciences, physiology, or other related 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)
• Familiarity with multi-center trials
• Experience with Institutional Review Board (IRB) Submissions

Competencies, 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
• Ability to work independently within a strong team environment
• Outstanding customer service skills
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information
• Proficiency with MS Office including Excel, Word, and PowerPoint
• Ability to manage multiple responsibilities, often under time constraints
• Attention to detail and ability to accurately prioritize workflow

Conditions of Employment

• Must successfully pass a drug test through Children's Hospital Colorado
• Must be willing and able to pass a national criminal background check

Special Instructions to Applicants: Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Questions should be directed to: Carrie Chambers at Carrie.Chambers@cuanschutz.edu Application Materials Required: Cover Letter, Resume/CV, List of References Application Materials Instructions: Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin immediately and will continue until the position is filled PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 21016 - SOM-PEDS ID-GenOps

Schedule: Full-time

Posting Date: Aug 15, 2022

Unposting Date: Ongoing Posting Contact Name: Carrie Chambers Posting Contact Email: Carrie.Chambers@cuanschutz.edu Position Number: 00794179





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