Study Builder/Research Programmer, Public Health Institute
The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally and internationally. PHI was distinguished as one of the top 50 “Best Non-profit Organizations to Work For” by the Non-Profit Times in a national search.
PHI is seeking a Study Builder / Research Programmer for the Children’s Oncology Group. This position is located in Monrovia, CA.
The Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. An overarching principle of COG is to ensure that the organization’s structure is optimized to maximize the potential for research that improves the outcome for every successive generation of children with cancer.
In collaboration with the study team, the Research Associate IV (RAIV) (Study Builder) will be responsible for all aspects of study set-up for clinical trials within COG Electronic Data Capture (EDC) systems. This includes working closely with COG protocol and research coordinators, members of the study committee and Case Report Form Review (CRF) committee, statisticians, the Information Technology (IT) department, and other staff responsible for implementing COG studies.
The Study Builder will also amend existing trials within EDC systems and will perform end user screen testing in the User Acceptance Testing (UAT) environment as well as create custom reports as needed.
Duties & Responsibilities:
- Review and provide feedback on study protocols especially with regards to section(s) pertaining to data collection and data management, ensuring that the database is designed to accurately capture the data required to meet the study aims.
- Work closely with the study research coordinator throughout CRF development, ensuring that each of the properties required for study set-up in the EDC system are identified and compliant with the protocol prior to CRF Committee Review and are in accordance with internal standard operation procedures (SOPs).
- Participate in CRF Review meeting calls presenting potential data collection and/or management issues as well as suggestions to enable an efficient study build.
- Define study schema and form roll-outs using PowerPoint.
- Utilize and maintain forms within a Global Library, as needed for EDC systems.
- Set up the study framework in the EDC system (i.e. folders, forms, fields, matrices, and restrictions) and build edit checks and derivations per the finalized CRF specifications.
- As part of UAT, complete testing, refinement, documentation and release of electronic CRF forms adhering to the established development procedures and internal SOPs.
- Upon confirmation of study activation, prepare and release the electronic CRF forms into the EDC system production environments.
- Attend study team meetings, regularly provide study progress updates, and address any study build issues, as needed.
- Build custom data management reports based upon study committee requests and protocol requirements.
- In collaboration with the research coordinator, continually assess implemented CRFs in all EDC systems to determine if modifications or enhancements to data elements and/or data validations are required to prevent and correct data errors and omissions.
- Participate in additional EDC related training as required.
- Perform other duties as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor’s degree or higher in a relevant field.
- Minimum of 5 years of related experience, with a minimum of 4 years in study building or clinical data management.
- Minimum of 1 year of experience building studies in an EDC system is preferred.
- Clinical research experience is highly desirable.
- Strong organizational skills.
- Ability to handle a variety of tasks and work independently.
- Broad knowledge of Microsoft Office software (MS Word, Excel, Project, PowerPoint and Access) and Internet databases.
- Strong verbal and written communication and interpersonal skills is preferred.
- Medidata RAVE Certified Professional highly desired.
This is an exempt position and the salary is commensurate with experience. PHI offers a generous benefits package including medical, dental, vision, short/long term disability insurance, life insurance, 403b (group retirement annuity) and partial subsidy of public transportation cost. For more information about PHI’s benefits, visit our benefits page at https://www.phi.org.
How to apply:
To apply for this position visit our Career Site at https://www.phi.jobs.
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