Research Data & Reporting Analyst

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 Manager of Clinical Research Data Quality & Reporting, the Research Data and Reporting Analyst is responsible for ensuring compliance with the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP) and the FDA's ClinicalTrials.gov reporting requirements. The candidate will be responsible for registering appropriate trials to CTRP and clinicaltrials.gov, and ensuring ongoing reporting requirements are met for trial status and accrual. To fulfill reporting requirements, the analyst will be required to collaborate with many teams across City of Hope Cancer Center including clinical research teams, investigators, and regulatory team members.

Key Responsibilities include:

• Submission to NCI CTRP and NIH ClinicalTrials.gov
  • Ensure timely registration of investigator initiated clinical trials to CTRP and ClinicalTrials.gov
  • Aggregate and review clinical data including research protocols, regulatory documents and other documents related to CTRP and ClinicalTrials.gov from a variety of sources ensuring accuracy, timeliness, confidentiality, and security of data
  • Track outstanding submissions to ensure compliance with regulatory requirements, including identifying and resolving problems that could interfere with meeting submission requirements. This also includes prompt recognition and appropriate referral of problems that require escalation
  • 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
  • Maintain existing clinical trials in CTRP and ClinicalTrials.gov including trial status updates and amendments
  • Timely submission of quarterly accruals into CTRP on all applicable trials
  • Collaborate with Clinical Research team members across the City of Hope enterprise to ensure needed regulatory data and subject enrollment data is collected accurately and in a timely manner
  • Monitor notifications and reports from OnCore to track new trials and manage trial status changes for CTRP and Clinicaltrials.gov
  • Maintain data sources that are used to verify CTRP and ClinicalTrials.gov current and historical entries for accuracy and completeness
  • Maintain oversight of all City of Hope records to ensure timely updates by study teams and timely entry of results data as required by the regulations
  • 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
  • In collaboration with the Manager of Clinical Research Data Quality & Reporting, develop and maintain standard operation procedures, education materials, tip sheets and other documents as required
  • Monitor and respond to questions and requests received by CTRP@coh.org support email
  • 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 and accrual reporting
  • 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 Manager of Clinical Research Data Quality & Reporting
• Other responsibilities
  • Perform additional related duties and projects as assigned or requested, and workshops.
  • Attends meetings as required.

Follows established City of Hope 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. Practices a high level of integrity and honesty in maintaining confidentiality. Performs other related duties 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, CTRP registration and accrual site, and ClinicalTrials.gov 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.

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: Jun 25, 2021
• Job Field: Research Administration
• Employee Status: Regular
• Shift: Day Job