Research Instructor

Job Summary:

The Research Instructor in the iC42 Clinical Research and Development group is a hands-on individual responsible for the group's clinical trials strategic initiatives. Such responsibilities include developing program/project goals and communicating goals, progress, and outcomes with a variety of stakeholders; participating in tactical and strategic program/project development and planning, including managing strategic infrastructure and resource, strategic collaborations, organization of collaboration among sites, site training and education, quality control, risk assessment, developing milestone, deliverables, managing scope, and delivering the scope on-time and on budget.

The Research Instructor will coordinate, administer, organize and document all of iC42 Clinical Research and Development's clinical trials operations and therefore manage all relevant communications with the Clinical Investigators, Laboratory Director, Administration, Quality Assurance, IRB, University of Colorado Regulatory Affairs and Compliance, the Colorado Clinical Translational Sciences Institute including its clinical trials services and Regulatory Knowledge and Support group, software programmers, IT, database managers, clinical sites and sponsors.

The Research Instructor will manage and supervise all aspects of the day-to-day operations of iC42 Clinical Research and Developments clinical trials operations. The individual will also carry out these processes. Given their oversight of clinical and laboratory research staff, the position is responsible for the development and maintenance of standard operating procedures, and training of personnel, and implementation. Moreover, this position is also responsible for the recruitment of personnel in collaboration with the Department of Anesthesiology's Administration and Human Resources.

Key Responsibilities:

• Contribute to clinical trial design and protocol writing which will also include Site visits, inspections, CRF, database audits, resolution of queries and corrective actions
• Communication with the regulatory team and assistance in FDA IND and IRB submissions
• Clinical trials advertisement and recruiting as well as registration, maintenance and update of ClinicalTrial.gov entries
• Communicating with participants regarding study objectives through obtaining written consent/ assent
• Collecting data obtained from research, coding and analyzing it. This includes the design and setup of eCRFs, data entry and review in electronic clinical trials system such as REDCap
• Design, oversight over the preparation, documentation and quality control of sample collection kits as well as making sure that all equipment and supplies needed for the study are in-stock and in good working order
• Sample collection (e.g. blood draws), sample processing and analysis

Work Location:

Onsite - this role is expected to work onsite and is located in Aurora, Colorado.

Why Join Us:

iC42 Clinical Research & Development is a cutting-edge bioanalytical resource and Service Center at the University of Colorado as well as a CU Medicine site of clinical practice. iC42 Clinical Research and Development provides clinical toxicology and therapeutic drug monitoring and carries out its own clinical trials, in collaboration with the biotech/ pharmaceutics industry and academic collaborators. iC42 Clinical Research and Development has a CAP/CLIA accredited laboratory with 17 LC-MS/MS systems, a pharmacokinetics/ pharmacokinetic modeling group, quality assurance unit and a clinical toxicology laboratory, serves as a central laboratory for multi-center clinical trials and is set up to run clinical trials including design, protocols, coordination and conduct, pharmacokinetics/ toxicokinetics, statistical analysis to reporting.

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:

Applicants must meet minimum qualifications at the time of hire.

• Master's degree in a medical field such as nursing
• 5 years of documented experience in clinical trials management, coordination and/ or as a research nurse
• Certification as phlebotomist

Preferred Qualifications:

• A PhD in a field related to biomedical research
• More than 5 years of relevant experience
• In-depth knowledge and experience in regulatory requirements and drug agency interactions
• Service on an IRB
• Relevant experience in the clinical CRO industry

Knowledge, Skills and Abilities:

• Medical and scientific knowledge: A Research Instructor does not have to be a doctor, pharmacist or scientist, but they do need to have some knowledge of this field. They should understand the basics of biochemistry, pharmacology and chemistry to make decisions without constantly having to check with researchers.
• Analytical mindset: A Research Instructor needs analytical skills to collect and interpret data, taking note of patterns or outcomes that those in charge of the trial need to be aware of.
• Background in research: Being a Research Instructor requires an in-depth knowledge of the research process. A Research Instructor must know how to set up a trial and collect and interpret the data.
• Excellent interpersonal skills: This position often requires interaction with researchers, participants and stakeholders, so the ability to communicate and solve problems is essential.
• Exceptional written and verbal communication skills: This is needed to actively communicate the requirements of the trial steps to participants and to liaise with laboratory staff and managerial staff.
• Outstanding organizational and managerial skills: Since clinical trials require the coordination of large and complex trials, multiple participants and large amounts of data, a Research Instructor must be very organized and have good managerial skills.

How to Apply:

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. Five professional references including name, address, phone number (mobile number if appropriate), and email address

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

Questions should be directed to: Abigail Jacoba (abigail.jacoba@cuanschutz.edu)

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by October 1, 2024

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as HIRING RANGE:

$76,700

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 unless it is non-exempt.

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 hr.adacoordinator@ucdenver.edu.

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.