Senior BMT Clinical Research Data Coordinator

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 best of the best pediatric hospitals with #1 rankings in Colorado and the region 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 Data Coordinator is responsible for implementing and coordinating multiple phases of data collection and management for patients treated during phases I-III of clinical trials, federally mandated reporting and internal quality databases in collaboration with a research team. Responsible for direct abstraction of data from Electronic Medical Records (EMRs), recording and reporting of patient data, and data entry into forms, electronic Case Report Forms (CRFs), and sponsor's proprietary Electronic Data Capture (EDC) systems, as well as responding to data queries in a timely fashion and auditing/cleaning database entries. Accountable for acting as a team lead and for providing mentorship to team members.

We are looking for a motivated, highly organized, team-oriented person to join our Bone Marrow Transplant (BMT) Research Team here at Children's Hospital Colorado! The Center for Cancer and Blood Disorders at Children's Hospital Colorado has one of the best pediatric hematology, oncology (cancer care) and bone marrow transplant programs in the country.

We treat kids, adolescents and young adults from birth through mid-20s with cancer and non-malignant blood disorders. The BMT program is one of the most experienced pediatric bone marrow transplant programs in the country. Our team is the region's most experienced pediatric blood and marrow transplant and cellular therapy (BMT) program. We have performed more than 1,100 bone marrow transplants and have a growing cellular therapy program offering new, effective and less toxic therapies for a variety of diseases. We're using it to pioneer treatments with the hope of eradicating childhood disease and changing pediatric medicine - giving all kids a chance at a healthier future.

Our extraordinary team at Children's Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

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

*This is a hybrid position.

• Education: Associate's degree is required.
• Experience: Minimum of three (3) years of related experience is required.
• Equivalency: Combination of education and related experience equivalent to five (5) years may be considered in lieu of minimum requirements.
• Previous healthcare experience
  • Oncology. Hematology, Laboratory, Pathology experience is a plus
• Previous experience navigating EPIC

POPULATION SPECIFIC CARE

No direct patient care.

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.

• Meets with representatives from sponsoring organizations or in-house staff for initial orientation to studies and for review of study records to ensure adherence to study protocol and to comply with Good Clinical Practices. Serves as a contact person for ongoing clinical research studies.
• Reviews team members' data work to ensure accuracy and completion. May assign, review and train other team members on various data responsibilities.
• Assists in the ongoing improvement of procedures for data reporting processes as well as other systems that support data aspects of clinical research efforts. Continuously assesses and optimizes departmental work flow and tools for the research teams as it relates to data submission and queries.
• Obtains safety reports from sponsor/external database, confirms Principal Investigator's (PI's) acknowledgment, and processes safety reports prior to continuing review for submission.
• Responsible for the accurate submission of study data to sponsors, federally mandated data reporting and/or data entry and maintenance of internal quality database for program evaluation.
• Directly abstracts patient data from the EMR and responsible for requesting patient records from outside institutions.
• Creates CRFs to maintain accurate research and compliance records; transfers source documentation into CRF.
• Works with study team members to facilitate preparation for monitor visits, supporting monitor visits, data audits and data locks.
• Maintains good communication and works closely with sponsors and outside agencies; submits data to them in a timely manner, meeting deadlines. Responsible for following up on any pending data and/or sponsor queries post submission and facilitating responses/resolution. Accurately documents all submissions and correspondence in a timely manner.
• Requests and uploads scans to sponsors for review at disease assessment time points.
• Plans, organizes, and assists with patient study eligibility, registration and enrollment.
• Recognizes when others need to be included in conversations and escalates appropriately.
• Accountable for serious adverse event reporting to sponsors including initial and follow up reports. Creates source binders for enrolled patients to retain study records/source documentation and maintains/organizes for data verification.

SCOPE & LEVEL

Guidelines: Possesses knowledge of and applies the fundamental concepts, practices and procedures within a particular field of specialization.

Complexity: Duties and tasks are varied and somewhat complex, but usually involve limited responsibility. Procedures, methods and techniques to carry out work may not be well defined, requiring greater analysis.

Decision Making: Has some discretion in making some decisions. Decisions and recommendations are made after contemplative analysis and with independent judgment and ingenuity. May escalate the most complex and important decisions to a higher level employee, supervisor and/or manager.

Communication: Communicates explanatory and/or interpretive information relative to the organization and/or own function with team members, peers, management, clients and in limited cases, the public. Uses some discretion and independent judgment when information is exchanged, gathered and/or presented. Defers to higher level team members and/or management in many situations.

Supervision Received: Works under some supervision, conferring with higher level employees, supervisor and/or manager as needed.

PHYSICAL REQUIREMENTS

Vision - Near: Clear vision at 20 inches or less
Weight Lifted/Force Exerted: Up to 10 pounds/4.5 kilos, up to 1/3 of time
Hearing: Able to clearly hear details
Sit: 2/3 or more of time
Talk: Able to communicate verbally
Mental/Emotional: Able to work in close proximity to others and/or in a distracting environment
Mental/Emotional: Able to cope with stress effectively
Mental/Emotional: Able to prioritize effectively

WORK ENVIRONMENT

Mental/Emotional: Able to tolerate ambiguity
Mental/Emotional: Able to prioritize effectively
Mental/Emotional: May be subject to many interruptions
Bloodborne Pathogen Category 2: Occasional exposure to blood/body fluid

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.