Senior Clinical Res Data Coord

SUMMARY

The role of The CIBMTR Senior Data Coordinator plays a critical role in abstracting and reporting complex clinical data for both malignant and non-malignant diseases utilizing specialized CIBMTR FormsNet applications. This position requires exceptional clinical accuracy and an acute attention to detail when reviewing electronic health records, pathology, and laboratory data to ensure error-free data entry into comprehensive pre- and post-transplant forms. Additionally, the ideal candidate will ensure absolute compliance with continuous CIBMTR reporting trimesters and strict form submission deadlines, while actively participating in internal and external FACT and CIBMTR audits to maintain our center's accreditation and high standards of data integrity

The Clinical Research Data Coordinator Senior 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.

SHIFT

Bone Marrow Transfusion

Monday - Friday

7:30 a.m. - 4:30 p.m.

This is an outpatient-based role with flexibility for a hybrid remote/in-person schedule based on demonstrated performance, role responsibilities, and the ability to work effectively and independently.

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. 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.
2. Reviews team members' data work to ensure accuracy and completion. May assign, review and train other team members on various data responsibilities.
3. 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.
4. Obtains safety reports from sponsor/external database, confirms Principal Investigator's (PI's) acknowledgment, and processes safety reports prior to continuing review for submission.
5. 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.
6. Directly abstracts patient data from the EMR and responsible for requesting patient records from outside institutions.
7. Creates CRFs to maintain accurate research and compliance records; transfers source documentation into CRF.
8. Works with study team members to facilitate preparation for monitor visits, supporting monitor visits, data audits and data locks.
9. 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.
10. Requests and uploads scans to sponsors for review at disease assessment time points.
11. Plans, organizes, and assists with patient study eligibility, registration and enrollment.
12. Recognizes when others need to be included in conversations and escalates appropriately.
13. 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.

MINIMUM QUALIFICATIONS

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.

Certification(s): None

Licensure(s): None

PREFERRED QUALIFICATIONS

• CIBMTR Expertise: 3+ years of direct experience with CIBMTR FormsNet data abstraction, including complete familiarity with continuous reporting trimesters and the managing of strict form submission timelines.

• Audit Experience: Proven track record of actively participating in or leading preparation for external FACT (Foundation for the Accreditation of Cellular Therapy) audits and CIBMTR data audits.
• Clinical Knowledge: Strong clinical background in oncology, hematology, or cell therapy, with specific experience abstracting data for both malignant (e.g., leukemias, lymphomas) and non-malignant (e.g., sickle cell disease, bone marrow failure syndromes) diagnoses.
• Systems Proficiency: Experience navigating complex Electronic Health Records (Epic Systems preferred) to synthesize pathology, laboratory, and clinical outcomes into highly accurate registry records.
  

Salary Information
Pay is dependent on applicant's relevant experience.

Hourly Range: $32.17 to $48.26

Benefits 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.

EEO Statement
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.

#LI-JW1