Research Data & Reporting Analyst

Location
Monrovia, California
Salary
Competitive
Posted
May 21 2021
Ref
10010722
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

Reporting to the Operations Manager, Clinical Research Protections, the Research Data and Reporting Analyst is responsible for ensuring compliance with the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP) reporting requirements. The Analyst will be responsible for registering appropriate trials to CTRP and ensuring ongoing reporting requirements are met for updates to trial status. To fulfill reporting requirements, the Analyst will be required to collaborate with many teams across City of Hope's Cancer Center including but not limited to clinical research teams, investigators, Research Applications & Data Management (RADM) team members, and regulatory staff.

Key Responsibilities include:

Submission to NCI CTRP
  • CTRP related information entry and management:
    • Update and manage CTRP Data Table 4
    • Perform data verification for clinical trials in CTRP
    • Update Primary Completion Date & Completion Date in CTRP. Communicate with RADM team for update of these fields in CT.gov to ensure alignment.
    • Maintain existing clinical trials in CTRP including trial status updates and amendments
    • Ensure timely registration of applicable clinical trials to CTRP for initial study registration and amendments
  • Aggregate and review clinical data including research protocols, regulatory documents and other documents related to CTRP from a variety of sources ensuring accuracy, timeliness, confidentiality, and security of data
  • Review CTRP's trial summary reports (TSRs) and ensure the quality of abstractions by cross-checking data and verifying content from source documents for accuracy. Once NCI CTRO approves TSR, notify RADM that record is available to upload to CT.gov (applicable for both initial study registration and amendments).
  • Track unresolved submissions to ensure compliance with regulatory requirements, including identifying and resolving problems that could interfere with meeting submission requirements, including prompt recognition and appropriate escalation of issues that require resolution.
  • Maintain data sources that are used to verify CTRP current and historical entries for accuracy and completeness. Collaborate with stakeholders to resolve discrepancies as needed.
  • CTMS Related Activities:
    • Update CTMS with NCI Number
    • Track submission status of required clinical trials to CTRP in CTMS and other relevant tools (e.g. database, dashboard, or spreadsheet) to provide transparency of current registration status for COH investigators and research teams
    • Monitor notifications and reports from CTMS to track new trials, amendments, and manage trial status changes for CTRP
  • Respond to inquiries from NIH, COH, sub-organizations, and external organizations or agencies regarding CTRP trial registration and status.
  • Collaborate with RADM team for coordinated effort for CTRP (managed by CRP) and CT.gov (managed by RADM) related activities.
  • Collaborate with Clinical Research team members across the enterprise to ensure needed regulatory data required for study registration is collected accurately and in a timely manner. Collaborate with stakeholders to resolve discrepancies as needed.
  • Follow establish COH and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan
  • Practice a high level of integrity and honestly in maintaining confidentiality and proprietary information

Training, Document Development and Maintenance, and Support
  • Develop and maintain standard operation procedures, education materials, tip sheets and other documents as required related to the Analyst's work.
  • Monitor and respond to questions and requests received by the CTRP@coh.org support email as well as other requests related to CTRP trial registration and status.
  • Maintain up-to-date knowledge of regulatory requirements for submission and maintenance of clinical trials registration and accrual reporting.
  • Provide training and education to study teams and staff at COH regarding updated regulations and requirements for clinical trials registration.
  • Participate in research team meetings to identify and implement ways to improve data reporting practices, procedures, and workflow.
  • Prepare related reports as requested by the Operations Manager of Clinical Research Protections.

Support CRP Operations Team (as needed)
  • Finalize activation of protocols and support document management in the CTMS.
  • Provides coverage support for Committee Management and Intake Coordination for the IRB and Scientific Review committees as needed. This could include assistance in managing the committee central email account and office central phone line, evaluating email requests and triaging messages to appropriate persons for response. This could also include meeting scheduling and attendance confirmation, reviewer assignments, general submission pre-review and coordination of protocol submissions in the electronic submission system, CITI training questions, and facilitating translations.

Other responsibilities
  • Perform additional related duties and projects as assigned or requested


Basic education, experience and skills required for consideration:
  • Bachelor's Degree in life sciences, information technology, business administration, or related fields.
    • Or 6 years of related experience may substitute for minimum education requirements.
  • 3 years relevant business experience.
    • Or Master's Degree + 1 year relevant business experience.

Preferred education experience and skills:
  • Experience in clinical research environment.
  • Previous experience with ClinicalTrials.gov and the requirements of FDAAA and FDAMA.
  • Experience with a CTMS, CTRP database, and CTRP registration site.
  • Experience with data management and quality assurance.
  • Proficiency with Microsoft Word, Excel, Outlook.

Skills/Abilities:
  • Knowledge of basic human anatomy, physiology, oncology, clinical research, and medical terminology
  • Strong written and verbal communication skills, attention to details, customer service, and intellectual curiosity
  • Proven ability to work accurately and efficiently and outstanding organization skills to simultaneously manage multiple projects and complex data sets
  • Demonstrated ability to work independently and with a team
  • Excellent organizational and analytic skills, with the proven ability to multi-task, trouble shoot, problem-solve, and prioritize work.
  • Knowledge of the regulations governing clinical trials registration and ability to handle time sensitive documents and maintain strict deadlines

Additional Information:

To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability. #LI-GD

  • Posting Date: Sep 20, 2021
  • Job Field: Research Administration
  • Employee Status: Regular
  • Shift: Day Job

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