Electronic Data Capture Clinical Analyst - EDC ( Electronic Data Capture Clinical Analyst)

    • Duarte, CA

Thanks you for your interest. Please note the purpose of this posting is to recruit for on-going and future positions.


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
The Electronic Data Capture Clinical Analyst supports the Electronic Data Capture (EDC) team through the development of custom electronic Case Report Forms (eCRFs) specific to City of Hope’s investigator initiated therapeutic trial portfolio. The service provided by the larger EDC group is designed to supply clinical investigators with eCRFs via both Medidata Rave and Forte EDC platforms, which in turn allow for efficient data capture and corresponding analysis following the completion of each clinical trial.

The Electronic Data Capture Clinical Analyst is responsible for leading the form development process through collaboration with existing EDC team members, clinical team representatives, biostatisticians, data monitoring/analysis staff, and other staff scientists. He/she will endeavor to capture the necessary specifications required to build a given clinical trial’s case report forms based on information presented in each IRB-approved and COH endorsed protocol. This specification document will then be delivered to a corresponding EDC Analyst for true form development. Following this stage, the Clinical Analyst is also responsible for verifying that each form has been developed appropriately through User Acceptance Testing whereby findings are documented and addressed before any approval is granted. Furthermore, he/she will play a pivotal role in drafting help text or instructional details for each required data entry field that will ultimately create a consistent and efficient data entry process.
The Clinical Analyst will also hold similar responsibilities when considering protocol amendments, meaning testing, documenting changes, approving, and updating help text are likely to occur multiple times throughout a trial’s lifecycle.

Key Responsibilities include:

  • Provides best-in-class delivery of informatics data capture tools, such as Medidata Rave and/or Forte EDC, to support City of Hope clinical investigators and their locally written trial portfolio.
  • Works closely with clinical researchers to analyze their business requirements and translate them into functional requirements.
  • Repeats these essential functions as needed to support both new trial form development as well as maintenance of existing forms based on updated protocol information.
  • Provide insight and support to clinical teams, biostatisticians, staff scientists, data quality / monitoring, and EDC development staff through the management of the case report form specification documentation process. This includes drafting specifications for all trials requiring data capture elements that will be managed by COH (typically these are representative of therapeutic internally initiated clinical trials).Use expertise in the clinical setting, as well as in-depth understanding of a given trial’s requirements through the specification document development process, to adequately test form function and usefulness (User Acceptance Testing). This is supplemented by the provision of detailed documentation specific to changes required prior to approval.
  • Provide approval for all case report forms and assist in the development of help text specific to each data capture element that has been created in a given clinical trial’s form set.
  • As needed, provide training to end user staff on appropriate data capture techniques. Act as a point person for the EDC team specific to studies where COH behaves as the data coordinating center (multi-center trial operations).
  • Assist with the establishment and implementation of policies and procedures governing EDC service delivery operations, including but not limited to system assessments, form library revisions, and workflow redesign. Assist with case report form development as needed to supplement the work provided by the Clinical Analyst’s counterparts on the EDC team.


Qualifications

Basic education, experience and skills required for consideration:
  • Bachelor’s degree in Biology, Chemistry, Physics, Public Health, Engineering, or Business; or equivalent combination of education and experience.
  • 5 years experience in Academic Medical Centers or Health Research Organizations, focusing on clinical trials management, coordination, and/or data capture. Candidates should be well-versed in the complexities of the clinical trial landscape, key players, and expectations surrounding data capture and data use.
  • Experience working closely with data capture tools such as Medidate Rave or Forte EDC


Preferred education experience and skill:
  • Medidata Rave Study Builder Training, Forte EDC Study Builder Training
  • Masters degree or higher preferred.
  • Oncology clinical research experience a plus.
  • Ability to analyze complex clinical trial protocols and refine language into an external system.
  • Must have the ability to work closely and effectively with a diverse group of administrators.


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.


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