Child Health Research Senior Coordinator - 32877 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Clinical Research Operations and Services – OVCR

Job Title: Child Health Research Senior Coordinator

Position #820513 – Requisition #32877

Job Summary:

Key Responsibilities:

• Acts as primary contact and/or liaison for investigators, sponsor representatives, and study teams for relevant research studies for Preaward and startup activities. Relays timely information to and between appropriate stakeholders for child health research.

• Establishes bi-directional communication and feedback channels with CU and CHCO partners as well as CU schools/depts conducting clinical child health research at CHCO.

• Serves as a reference point within CROS for questions and guidance related to the processes involved in clinical trial pre-award and startup activities as well as activities occurring after the award.

• Assists with tactical work for specific projects.

• Acts as a subject matter expert for clinical trial startup activities needed to successfully open trials at CHCO and CU.

• Develops relationships with key groups within the CHRE, ORC, CROS, Office of Grants and Contracts, Dept of Pediatrics, and other relevant groups.

• Independently reviews study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies to assist investigators and teams working to open clinical trials at CHCO.

• Actively consults in pre-award and study startup meetings, as appropriate. May serve as a resource and assist with study initiation and close out activities.

• Works with appropriate monitoring and auditing teams to support compliance with applicable regulations (FDA; OHRP, etc.), external and internal policies (NIH; CU and hospital affiliates, IRBs, etc.) departmental Standard Operating Procedures (SOPs), and research standards and best practices (ICH Good Clinical Practice (GCP), and Good Documentation Practices (GDP), etc.)

• Supports research teams to manage regulatory submissions to local and central IRBs, FDA, and other regulatory agencies via established processes. Fields questions and provides study-specific updates related to regulatory submissions and progress.

• Supports research teams to develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs) to facilitate trial opening with CU investigators at CHCO.

• Partners with and escalates systemic issues and patterns to appropriate leaders to ensure timely problem solving for any issues, barriers or decisions that may be required.

• Is involved in special projects in collaboration with teams, supervisors and/or leadership in creating and implementing processes and procedures and quality improvement initiatives related to operational efficiency.

• Accurately tracks metrics and performance indicators for study start up. Provides feedback data and reports to CU and CHCO leadership on processes, obstacles, and issues.

• Provides excellent customer service to both internal and external stakeholders by presenting a positive image of the OVCR, CHCO and CU

• Exercises independent critical thinking and decision making to ensure the successful setup and implementation of assigned studies.

Work Location:

Hybrid

Why Join Us:

Diversity and Equity:

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

• 2 years of professional level related experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Prior experience with clinical trial startup at an academic institution, pediatric hospital, or other clinical trial site

• One or more years of clinical research or related experience working at CU Anschutz or CHCO

• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)

• Clinical research drug and/or device study coordination experience

• Research training: CITI, GCP, IATA, blood borne pathogens.

• Experience completing routine clinical research tasks and documentation, such as conducting informed consent or assessing eligibility.

• ACRP or SOCRA certification

• Experience with EMR (electronic medical record system) and CTMS systems (Oncore)

• Experience with RedCap, eCRF databases.

• Experience administering questionnaires or assessments (e.g., cognitive assessments)

• Bilingual (Spanish & English)

Competencies:

• Working understanding of clinical trial pre-award and financial setup activities

• Working understanding of clinical research operations and post award finance management

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)

• Knowledge and familiarity with clinical research study conduct

• Project management skills

• Basic statistical skills

• Ability to interpret and master complex research protocol information.

• Respect for patient rights and dedication to patient safety and protections; excellent patient rapport.

• Empathetic to patients with chronic illnesses

• Great attention to detail and quality

• Ability to work with colleagues and patients in a confidential and professional manner.

• Ability to follow and execute a study protocol and proactively prevent deviations.

• Ability to follow direction of institutional leadership, follow all department SOPs and department policies.

• Critical thinking and sound judgment

• Outstanding organizational and time management skills

• 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.

How to Apply:

Screening of Applications Begins:

Anticipated Pay Range:

or hiring range $56,169 - $71,447.

or hiring range

ADA Statement:

Background Check Statement:

Vaccination Statement:

Job Category

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The Office of Clinical Research Operations and Services (CROS) is part of Office of the Vice Chancellor of Research (OVCR). This office provides operational support to clinical research investigators and teams on campus. CROS has an opening for a full-time Senior Clinical Research Coordinator to provide start up and pre-award guidance and support to investigators on the Anschutz Medical Campus who are setting up clinical pediatric studies at Children's Hospital Colorado (CHCO). This position may act as a navigator or consultant to help investigators, study teams and research programs engage and complete all required processes in order to successfully open new clinical research studies. This position will work independently with guidance and training from the Child Health Research Enterprise (CHRE) at CHCO and direct oversight and supervision from the Assistant Vice Chancellor for Clinical Research Operations and the Clinical Trial Operations Program Director in CROS. Knowledge and communication of CHCO and CU processes and teams are critical for the success of this position. Good Clinical Practice and Good Documentation Practices in the context of clinical research is also essential. We are seeking an individual who is collaborative, communicative, caring, detail oriented and organized, proactive, able to think critically, focused on quality, passionate about research,

– this role is eligible for a hybrid schedule of 1 day per week on campus and as needed for in-person meetings.

We are committed to a diverse, team-based culture. We engage and collaborate with the research community to provide expertise, support, and guidance for the advancement of science. Together, we make tomorrow's research happen. 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=5081135&targetURL=https://www.uchealth.org/locations/uchealth-university-of-colorado-hospital-uch/) and Children's Hospital Colorado (https://apptrkr.com/get_redirect.php?id=5081135&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=5081135&targetURL=https://www.cuanschutz.edu/) . 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 (https://apptrkr.com/get_redirect.php?id=5081135&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.

A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

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: Ben Echalier; Benjamin.Echalier@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5081135&targetURL=Benjamin.Echalier@cuanschutz.edu)

Immediately and continues until position is filled. For best consideration, apply by March 19, 2024.

The starting salary range () for this position has been established as The above salary 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=5081135&targetURL=http://www.cu.edu/node/153125)

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@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5081135&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=5081135&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=5081135&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 21976 - ADM AVC Clinical Res Operation : Full-time : Apr 16, 2024 : Ongoing Posting Contact Name: Ben Echalier Posting Contact Email: Benjamin.Echalier@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5081135&targetURL=Benjamin.Echalier@cuanschutz.edu) Position Number: 00820513jeid-1bdac8afcf02cb4cb2762702a5af8ec0

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.