REMOTE Sr Elec Data Capture Analyst
- City of Hope
- Duarte, California, United States
- $40.70 - $63.08 / hour
- Closing date
- Apr 1, 2023
- Life Sciences
- Position Type
- Full Time
- Organization Type
City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope's affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.
City of Hope's commitment to Diversity, Equity and Inclusion
We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.
** This is a Fully Remote Opportunity. You may sit at any of the 48 States **
The Senior EDC Analyst will support a vast portfolio of City of Hope therapeutic investigator-initiated studies that require data capture in a robust database. This includes over 100 clinical trials that have been historically supported by Medidata Rave and will continue to be supported by Forte EDC beginning in 2019. The team behaves as EDC experts and maintains primary responsibility over form design, development, validation, and updates on a recurring basis until study closure.
Key Responsibilities include:
- Work directly with study teams (Principal Investigators, Statisticians, Study Coordinators, etc) to understand specific workflows and requirements and build electronic Case Report Forms (eCRFs) in alignment with a given research protocol requiring EDC support.
- Design, develop, validate, and maintain applications used to capture eCRF data within Forte EDC.
- Provide programming of validation checks and custom functions on eCRFs to improve data quality.
- Develop specifications for standard edit checks, data listings and reports as needed.
- Work closely with research software developers / programmers to ensure that validations within Forte EDC meet study team needs.
- Create documentation related to requirements, user testing, findings, etc.
- Provide end user support; communicate with participating sites on data related tasks.
- Maintain familiarity with Bug / Issue Tracking tools to keep apprised of issues related to EDC software.
- Maintain familiarity with EDC-related industry Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines specific to federal and local regulations.
- Provide guidance and training to other analysts and assist other department staff members as necessary.
- Maintain effective communication with study teams related to protocol status and amendments that affect eCRFs.
- Perform impact analysis and risk assessment on all proposed application changes. Troubleshoot system errors. Maintain documentation of all programs and applications.
- Support research, evaluation and development of departmental initiatives and new technologies/innovations to improve processes. Report to regular conferences, training, and/or continuing education sessions to realize further department efficiencies and success.
- Performs other related duties as assigned or requested.
Basic education, experience and skills required for consideration:
- Master's degree in Science, Engineering, or Public Health.
- A minimum of 5 years' experience in healthcare / clinical research setting.
- Experience in form design and programming in an EDC, such as Medidata Rave, Oracle InForm and/or Forte Oncore / EDC, highly desired. Experience in clinical research operations, protocol development, and/or research coordinator a plus.
Preferred education experience and skills:
- Master's degree in Science.
- Medidata Rave Study Builder Training, Forte EDC Study Builder Training
- 5+ years of experience in healthcare / clinical research setting.
- 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.
- Must have a passion for excellent customer service and commitment to exceptional quality.
- Expresses commitment to City of Hope's mission, personally identifies with its vision and takes pride in shared success.
- Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required.
- Excellent written and oral communication
The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate's experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
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.
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
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