Senior Clinical Research Coordinator CCBD

Here, it's different. Come join us.

Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years.

Here, the nation's brightest nurses, physicians, scientists, researchers, therapists, and care providers are creating the future of child health. With an optimist's outlook, a trailblazing spirit, and a celebrated history, we're making new strides every day.

We've been Magnet-designated four times by the American Nurses Credentialing Center and are consistently recognized among the nation's top 10 pediatric hospitals by U.S. News & World Report.

As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 11 specialty care centers, 1,300+ outreach clinics and more than 10,000 healthcare professionals representing the full spectrum of pediatric care specialties.

Here, we know it takes all of us, every role, to deliver the best possible care to each child and family we treat.

That's why we build our teams toward a foundation of equity in access, advancement, and opportunity. We know teams of individuals with different identities and backgrounds can nurture creativity and innovation. We know we can see, treat, and heal children better when our team reflects the diversity of our patient population. We strive to attract and retain diverse talent because we know a truly inclusive and equitable workforce will help us one day realize our most basic calling: to heal every child who comes through our doors.

A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it's different.

The Senior Clinical Research Coordinator is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Facilitates the accomplishment of research programs and/or study goals. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under minimal supervision.

This position specifically supports the ETP (Experimental Therapeutics program) in the CCBD (Center for Cancer and Blood Disorders) early phase (phase I/II) clinical trial program. ETP offers investigational treatments for children, adolescents, and young adults with recurrent/refractory illness or with a diagnosis that has no reasonable cure. This program works with cooperative groups, consortiums, pharmaceutical (industry) studies, and PI initiated studies. The team member in this position is key to the completion of chart abstraction with heavy emphasis on AEs, CRF completion and submission, patient work up of eligibility and enrollment, specimen processing, storage and shipment, audit preparation and monitoring visits along with other administrative tasks and job essential functions. This role does not perform any data analysis, but is responsible for submitting all clinical data to sponsors. This position works closely with all ETP team members, inclusive of but not limited to colleagues, Regulatory Specialists, Nurses, APPs, and Physicians, but does not involve any direct patient care. The successful applicant will have a strong background as a CRC that compliments the needs of the ETP team.

Department: CCHRI-CCBD Clinical Research
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am to 4:30pm. Work hours may vary due to department needs.

*This position may allow for the occasional opportunity to work from home. This is dependent upon the successful completion of department on-boarding/training, offsite workload and job performance/competence.

• Education: Bachelor's degree in a related field is required.
• Experience: Minimum of three (3) years of clinical, clinical support, and or clinical research related experience is required.
• Equivalency: Associate degree in a related field with (5) five years of clinical related experience may be considered in lieu of minimum education requirement.
• Previous data entry and CRC pediatric oncology clinical trial experience (2+ years) preferred.
• Experience working with Phase I clinical trials, consortiums and industry are preferred.
• Previous experience with EDC systems, completion and maintenance of CRFs and study binders, reporting of AE's and SAE's (initial and follow-up) are preferred.

POPULATION SPECIFIC CARE

• Neonate - <30 days
• Infancy - >30 days to 1yr
• Toddlers - >1yr to 3yrs
• Pre-Schoolers - >3yrs to 5yrs
• School age - >5yrs to 13yrs
• Adolescent - >13yrs to 18yrs
• Adult - >18yrs to 65yrs

ESSENTIAL FUNCTIONS
An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

1. Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.
2. Regulatory - Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
3. Study Participation - Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.
4. Protocol - Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements. Assists with the development of proposals or protocols. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
5. Human Subject Research Protection - Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Serves as a resource and trainer for issues related to professional guidelines and code of ethics. Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution.
6. Team Coordination - Leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Provides significant contribution and influence upon research work, activities and/or productivity of study teams. Leads a committee or task force under direction of a supervisor. Leads scientific or programmatic presentations. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. Implements with leadership team on the operational elements needed for the conduct of clinical and translational programs and/or studies.
7. Quality Assurance - Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data and assists management with resolution. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and develops and implements retraining as appropriate. Adheres to and oversees the development and assessment of quality assurance processes. Identifies issues related to operational efficiency and shares results with team members and management. Recognizes when data agreements or special regulatory requirements are necessary and acts as a resource and mentor to determine when special contracts are necessary and escalates to stakeholders. Develops systems and/or frameworks for quality assurance processes in collaboration with leadership.
8. Budgets/Financials - Participates in and provides oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Comprehensive understanding of institutional process for the development of budgets. Proactively identify gap deficits and escalating.
9. Mentoring/Coaching - Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design.

SCOPE & LEVEL

Guidelines: Fully qualified, full performance or journey level. Guidelines are generally but not always clearly applicable, requiring the employee to exercise judgment in selecting the most pertinent guideline, interpret precedents, adapt standard practices to differing situations, and recommend alternative actions in situations without precedent.

Complexity: Duties assigned are generally complex and may be of substantial intricacy. Work assignment is performed within an established framework under general instructions but requires simultaneous coordination of assigned functions or projects in various stages of completion.

Decision Making: Exercises judgment and discretion, and is responsible for determining the time, place and sequence of the work performed.

Communication: Contacts with team members, clients, or the public where explanatory or interpretive information is exchanged, defended, and gathered and discretion and judgment are required within the parameters of the job function.

Supervision Received: Performs work with minimal supervisory oversight. Under general supervision, the employee receives assignments and is expected to carry them through to completion with substantial independence. Work is reviewed for adherence to instructions, accuracy, completeness, and conformance to standard practice or precedent. Recurring work clearly covered by guidelines may or may not be reviewed.

Ability to Perform Essential Functions of the Job

• Audio-Visual: Color Discrimination: Good
• Audio-Visual: Depth Perception: Good
• Audio-Visual: Far Vision: Good
• Audio-Visual: Hearing: Good
• Audio-Visual: Near Vision: Good
• General Activity: Sit: 2-4 hrs. per day
• General Activity: Stand/Walk: 2-4 hrs. per day
• Motion: Bend: Up to 1/3 of time
• Motion: Carry: Up to 1/3 of time
• Use of Hands/Feet: Both Hands - Gross Motor Function
• Use of Hands/Feet: Both Hands - Precise Motor Function (Or Fine Manipulation)
• Weight Lifted/Force Exerted: Up to 25 pounds: Up to 1/3 of time

Work Environment

• Equipment: Telephone, computers, reading reports/graphs
• Exposure: Exposure to blood/body fluid: Regular/Frequent
• Exposure: Exposure to chemicals: Occasional
• Exposure: Exposure to infectious diseases: Occasional
• Exposure: Exposure to radiation: Occasional
• Exposure: Exposure to skin irritations: Occasional
• Mental and Emotional Requirements: Handles multiple priorities effectively
• Mental and Emotional Requirements: Manages stress appropriately
• Mental and Emotional Requirements: Works alone effectively
• Mental and Emotional Requirements: Works in close proximity to others and/or in a distracting environment
• Mental and Emotional Requirements: Works with others effectively
• Mental and Emotional Stress: Managing workload and system issues
• Mental Stress: Multi-tasking, meeting deadlines, prioritizing

It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.

The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.

Here, you matter. As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children's Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.