Description
University of Colorado | CU Anschutz Medical Campus

Linda Crnic Institute for Down Syndrome

Research Services Professional (Open Rank)/Clinical Research Coordinator

Position # 00785062 – Requisition #21665

 

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

 

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.

 

Linda Crnic Institute for Down Syndrome has an opening for a full-time University Staff (unclassified) Research Services Professional (Open Rank)/Clinical Research Coordinator position.

 

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 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.

 

Nature of Work

The Linda Crnic Institute for Down Syndrome is seeking to employ a full time Clinical Research Coordinator (CRC). Depending on qualifications and department needs, appointments may be made at the CRC I, CRC II, or CRC III level.

As an important member of the research team, the Clinical Research Coordinator works with 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.  This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs.  This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits.  The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level.  This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.

 

Jobs in this 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 in this career family 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 may be more limited in scope and are performed with guidance and direction from other professionals.

 

At the senior level, work is performed fully independently.

 

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

• Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial. Performs 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
• Interviews prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
• Schedules subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy) 
• Familiar with protocol and all study documents and reviews documents after each study subject visit for completeness and accuracy
• Abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into the Cancer Center clinical trials database in an accurate and timely fashion
• Ensures complete source documentation is compiled for each study subject record
• Provides review of patient eligibility determination by:
• Gathering source documentation
• Ensuring the most current and approved version(s) of the study informed consent forms are completed and that the informed consent process is properly documented and consent form filed
• Reviewing study subject Medical History to determine eligibility status

Obtains oncology grading levels for study product toxicities, including assessment of clinical significance of all lab and test results and relatedness of adverse reactions to study product according to protocol guidelines

Schedules and tracks submission of Prescreening, Screening and Enrollment Logs, as required by Sponsor

Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)

Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor

Works on multiple research studies simultaneously

Serves as a liaison with Sponsors and with study subjects for ongoing clinical research studies 

Independently coordinates and manages data entry, queries, and monitor visits

Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses

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)

May be trained to perform the following on study subjects:  

Electrocardiograms

Measurement of blood pressure, pulse, height, weight, and temperature 

Phlebotomy (direct venipuncture) 

Research specimen collection, processing and shipping, develops protocol-specific source documents (e.g., data collection tools, study visit checklists, pharmacokinetic sample collection worksheets, etc.)

Assists Team Manager and/or Financial Team by processing bills and/or answering billing questions related to procedure performed for subjects enrolled in clinical trials

Serves as Primary Coordinator for clinical trials

Examples of Work Performed by Clinical Research Coordinator (Level II):

• Assists Team Supervisors with creation and conduct of process and quality improvement projects
• Trains, assesses, and mentors new Clinical Research Coordinators, as directed by Supervisor/Manager
• Serves as role model to all Clinical Research Coordinators – remains in compliance with all training requirements, meets established deadlines for data submission, possesses a strong understanding of clinical research history, regulations, and ethics

Examples of Work Performed by Clinical Research Coordinator (Level III):

• Assists Team Supervisor with creation of training process documents and tools
• Trains, assesses, and mentors new Clinical Research Coordinators, as directed by Supervisor/Manager
• Performs additional duties as assigned by team supervisor and manager
• Assists with study start-up tasks
• Serves as role model to all Clinical Research Coordinators – remains in compliance with all training requirements, meets established deadlines for data submission, possesses a strong understanding of clinical research history, regulations, and ethics

 

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 (or hiring range) for this position has been established at $38,000 to $43,000  

 

CRC I:  $42,830-$54,480

CRC II:  $46,609-$59,287

CRC III:  $50,388 -$64,094

 

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.

 

 

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:

Clinical Research Coordinator – CRC I Level

• Bachelor’s degree in any field.

Substitution: Any equivalent combination of Education and Experience can substitute for the degree on a year-for-year basis.

 

Clinical Research Coordinator - CRC II Level

• Bachelor’s degree in any field.
• One (1) year of clinical research experience and one (1) year of clinical and/or research experience. 

Substitution: Any equivalent combination of Education and Experience can substitute for the degree on a year-for-year basis.

 

Clinical Research Coordinator - CRC III Level

• Bachelor’s degree in any field.
• Two (2) years of clinical research experience and one (1) year of clinical and/or research experience. 

Substitution: Any equivalent combination of Education and Experience can substitute for the degree on a year-for-year basis.

 

Conditions of Employment – Clinical Research Coordinator Level III Only:

Additional certification is required for CRC III at the time of application (one of the below):

• CCRC – Certified Clinical Research Coordinator
• CCRP – Certified Clinical Research Professional
• CCRA – Certified Clinical Research Associate 

 

Required: Applicants must meet minimum qualifications at the time of hire.

 

PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

 

Preferred Qualifications:

• Oncology Clinical Research experience (any clinical research experience for CRC I level)
• Experience with electronic data capture systems
• Bachelor’s degree in science or health related field

 

 

Knowledge, Skills and Abilities:

• Knowledge of basic human anatomy, physiology medical terminology.
• Analytical Skills - Ability to interpret and master complex research protocol information.
• Attention to Detail – 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; is able to work independently and as part of a team.
• 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.

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jun 14, 2021
Unposting Date: Ongoing