Highlands Ranch Clinical Research - Aurora, United States - University of Colorado

Description

University of Colorado Anschutz Medical Campus


Department:
Cancer Center - CCTO


Job Title:
Highlands Ranch Clinical Research Coordinator (Open Rank- Level I, II, III)

Position # Requisition #32895


Job Summary:

The Cancer Center is looking to hire a full-time Clinical Research Coordinator (CRC) to work at our Highlands Ranch, CO location.

Examples of Duties Performed


Entry Level or CRC I:

• 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)
• Collaborates with hospital staff to ensure tests and procedures, required by research protocols, are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures)
• Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
• 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
• Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
• 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 or CRC II, all the 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 or CRC III, all the 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
• 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.

Work Location:
Onsite - this is 100% on-site at Highlands Ranch Hospital.


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.

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:

Diversity and Equity:
DIVERSITY, EQUITY, INCULSION AND ACCESS

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 to request an accommodation in accordance with the Americans with Disability Act.

Qualifications:
Minimum

Qualifications:
Entry Level or CRC I

• 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 or CRC II

• 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 experience or one (1) year of clinical (or related) experience

Senior Level or CRC III

• 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 experience and/or one (1) year of clinical research experience and one (1) year of clinical (or related) experience

Preferred Qualifications

• Bachelor's degree in science or health related field
• Three (3) years of clinical research or related experience
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• Additional certification (one of the following):
• CCRC - Certified Clinical Research Coordinator
• CCRP - Certified Clinical Research Professional
• CCRA - Certified Clinical Research Associate

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
• 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

Please be advised that this position is not eligible now or in the future for visa sponsorship.


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


Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by April 24, 2024.

Those who do not apply by this date may or may not be considered.


Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as

Level I (Entry) $47,084

Level II (Intermediate) $51,239

Level III (Senior) $55,393

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.


Total Compensation Calculator:

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


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.