Clinical Research RN (Open Rank)

University Staff

Description

University of Colorado Anschutz Medical Campus

Department : Cancer Center

Working Title : Clinical Research RN (Open Rank)

Position # : 748446 - Requisition # : 34387

Job Summary :

The Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center is seeking to employ a full time

Clinical Research Nurse (RN) . Depending on qualifications and department needs, appointments may be made at the RN I, RN II or RN III level.

As a member of the research team this position is responsible for conducting key aspects of research for Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH / GCP Guidelines.

In addition to acting as a clinical research coordinator, the RN is also responsible for drug administration, phlebotomy and pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures specifically related to clinical research studies as well as other clinical duties such as EKGs and Holter monitors as assigned based on appropriate licensure and / or completion of competency documentation and team needs.

The incumbent coordinates study subject appointments throughout the study and is responsible for data entry, study subject advocacy, and possible management of studies at the local level.

Examples of Work Performed by the Clinical Research Nurse (all levels)

• Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies.
• Relays timely information to Regulatory Affairs Coordinator in regard to protocols (e.g. addition of investigators, amendments, serious adverse events, consent form changes, monitoring visits, correspondence, continuing review and study termination reports) to ensure quality study flow and ensure that all governing regulations are being adhered to.
• Obtains medical history and current medications, reviews protocol inclusion / exclusion criteria, and confirms eligibility of subject.

Ensures that the informed consent process has occurred, is properly documented and filed as required.

• Recruits and interviews prospective subjects for multiple clinical studies. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews.
• Schedules subject participation in research, coordinating availability of necessary space, laboratory and physician support.

Coordinates with pharmacy staff dispensing of study medication under the direction of the Principal Investigator and / or Sub-investigators.

Assures compliance with protocol details, completes necessary records, and coordinates scheduling of subject and monitoring visits.

Accurately transfers source documentation into Case Report Form (CRF) within 10 working days. Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy.

Maintains patient clinical research files.

• Submits and / or manages treatment plans through the UCHealth Beacon process and works with assigned staff for completion of the treatment plan.
• Recognizes adverse events and serious events and promptly notifies appropriate parties; e.g. Principal Investigator, Study Sponsor, FDA, Data Safety and Monitoring Committee (DSMC), Regulatory Affairs Coordinator.
• Serves as a contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of study records.
• Participates in DSMC audits.

Patient Care Responsibilities

Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented.

These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG's, drug administration, Infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures.

May be called upon to perform the following specific tests and procedures specifically related to the research study : a) consenting, b) electrocardiogram, c)

blood pressure, pulse, height, weight, pulse oximetry, and temperature measurements, d)

phlebotomy and specimen processing and shipping

• Collaborates with the clinical team in developing all aspects of patient care.
• Assesses patient's pertinent health history.
• Develops protocol specific source documents (e.g. data collection tools, study visit checklists, pharmacokinetic sample collection worksheets).
• Assists team manager and / or financial team by processing bills and / or answering billing questions related to procedure performed for subjects enrolled to clinical trials.
• Rotates through department PK (blood draw) schedule as necessary
• Develop and review trial specific treatment (protocol)orders for accuracy and completeness prior to implementation in electronic medical record

Examples of Work Performed by Clinical Research Nurse (Level II)

• Serves as primary coordinator for clinical trials
• May be called upon for other department specific RN duties as needed
• Teach, precept, and mentor new employees, as directed by team manager
• Develop policy, procedure, patient education materials, and / or study tools as they relate to conduct of clinical research

Examples of Work Performed by Clinical Research Nurse (Level III)

• Serves on internal CCTO committee
• May be called upon for other department specific RN duties as needed
• Teach, precept, and mentor new employees, as directed by team manager

Works on proces s improvement projects within the department

Work Location :

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

Why Join Us :

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control.

Our guiding vision is clear : "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments.

Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

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 / year (maximum accrual 352 hours)
• Sick Days : 15 / year (unlimited maximum accrual)
• Holiday Days : 10 / year
• Tuition Benefit : Employees have access to this benefit on all CU campuses
• ECO Pass : Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage .

To see what benefits are available, please visit : https : / / www.cu.edu / employee-services / benefits-wellness

Diversity and Equity :

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations.

We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace.

We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center.

If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process.

Please contact the Human Resources ADA Coordinator at [email protected] to request an accommodation in accordance with the Americans with Disability Act.

Qualifications :

Minimum Qualifications :

Clinical Research Nurse - RN I Level (Intermediate)

• A bachelor's degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field from an accredited institution
• RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact)
• One (1) year of RN experience

Clinical Research Nurse - RN II Level (Intermediate)

• A bachelor's degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field from an accredited institution
• RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact)
• Two (2) years of medical / surgical or oncology nursing experience, which must include at least one (1) year of clinical research experience.

Clinical Research Nurse - RN III Level (Senior)

• A bachelor's degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field from an accredited institution
• RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact)
• Three (3) years of medical / surgical or oncology nursing experience, which must include two (2) years of clinical research experience

Substitution (for all levels) : Education (i.e. Associate's degree) and

professional level RN experience can substitute for the Bachelor's degree on a year for year basis

Condition of Employment - Clinical Research Nurse Level III Only

Additional certification is required for RN III at time of application

• One of the following certifications : OCN - Oncology Certified Nurse (obtained through ONS), CCRP - Certified Clinical Research Professional (obtained through SoCRA), or CCRC - Certified Clinical Research Coordinator (obtained through ACRP)
• Bachelor of Science in Nursing (BSN)

NECESSARY SPECIAL QUALIFICATION - ALL LEVELS

Candidate must have an active RN license Candidate must have an active Colorado nursing license or ability to obtain their Colorado license prior to start date.

Please include a copy of your current RN license with your submission.

• Preferred Qualifications
• CCRP - Certified Clinical Research Professional (obtained through SoCRA)
• CCRC - Certified Clinical Research Coordinator (obtained through ACRP)
• OCN - Oncology Certified Nurse (obtained through ONS)

Knowledge, Skills and Abilities

Knowledge of common pharmaceutical terminology.

Attention to Detail - Ability to interpret and master complex research protocol information; work is accurate and details are not overlooked.

Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.

Interpersonal Skills - Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner;

models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.

Customer Service - Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.

Complex Problem Solving - Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.

Adaptability - Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner;

is open to new ideas and methods.

• Planning and Organizing - Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
• Technical Skills - Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel);

ability to learn new technology.

Applicants must meet minimum qualifications at the time of application.

How to Apply :

For 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 : [email protected]

Screening of Applications Begins :

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by August 16, 2024.

Those who do not apply by this date may or may not be considered. Hiring department will need to notify their Talent Acquisition Consultant when they want to have the advertisements removed for the posting.

Anticipated Pay Range :

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

$56,556 - $77,848

If you have prior state-classified service in the same class series as this position, your pay may be set at a higher amount per the state Step Pay Program implemented on July 1, 2024.

For more information about the Step Pay Program, please visit the 2024 Step Pay Program for State of Colorado Employees DHR .

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 hr.

[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 .

Application Materials Required : Cover Letter, Resume / CV, List of References, Additional Attachments - Refer to Application Materials Instructions Below Application Materials Instructions : Candidate must have an active RN license Candidate must have an active Colorado nursing license or ability to obtain their Colorado license prior to start date.

Please include a copy of your current RN license with your submission.

Job Category

Health Care

Primary Location

Aurora

Department : U0001 Anschutz Med Campus or Denver - 20066 - SOM-U of Colo Cancer Center

Schedule

Full-time

Posting Date

Jul 30, 2024

Unposting Date

Ongoing

Posting Contact Name : Kristen Califano

Posting Contact Email : [email protected]

Position Number : 00748446