Research Associate IV, Data Manager and Programmer - Monrovia, CA | Biospace
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Research Associate IV, Data Manager and Programmer

Public Health Institute

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Location:
Monrovia, CA
Posted Date:
7/28/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Data Management, Oncology, Programmer, Research,

Job Description


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 Data Manager and 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.

The Data Manager and Programmer coordinates all data collection and management activities for assigned Children’s Oncology Group (COG) studies during study development, initial set-up, study maintenance and conduct. This entails working closely with the study team, study committee, and other staff responsible for implementing and conducting COG studies.  

The Data Manager and Programmer is responsible for creating, developing, and implementing Case Report Forms (CRFs), data validations, and data management plans (DMP) for assigned COG studies.  The position takes the lead on study set-up, build, and maintenance of assigned COG studies within COG Electronic Data Capture (EDC) systems, including end user screen testing in the User Acceptance Testing (UAT) environment.  In addition, this role monitors the quality and timeliness of submitted study research data, overseeing patient enrollments, conducting data cleaning activities, and creating custom data reports for all assigned studies.  The Data Manager and Programmer is required to amend CRFs per study needs, implementing the corresponding changes in the EDC system and DMP.

Duties & Responsibilities:

1.   Review and provide feedback on study protocols, especially 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.
2.   Coordinate with the study team on CRF development and set-up timelines, ensuring study activation is within mandated deadlines.  This includes identifying delays in study development and/or study set-up, and working to identify solutions.
3.   Design the CRFs and data validations (i.e., edit checks) required for assigned COG studies, ensuring consistency with the protocol, consent form documents and compliance with internal standard operating procedures (SOPs).
4.   Create common data elements (CDEs) as needed to capture essential research data for the study, or identify appropriate CDEs from existing repositories, following established guidelines and procedures.
5.   Organize and lead CRF Review meeting calls presenting potential data collection and/or management issues as well as suggestions to enable an efficient study build.
6.   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.
7.   As part of UAT, complete testing, refinement, documentation and release of electronic CRF forms adhering to the established development procedures.
8.   Review protocol amendments to determine if changes to the CRFs or study DMP are necessary. If necessary, draft CRF changes and coordinate appropriate review and approvals, implementing finalized changes in the EDC system as required.
9.   Maintain and monitor the conduct of existing trials, including managing patient enrollments/randomizations and opening, closing, or suspending studies, as required, according to established departmental SOPs and study DMPs.
10.   Build custom data management reports based upon study committee requests and protocol requirements.
11.   Monitor the quality of submitted research data through all EDC systems to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data.  Determine if modifications or enhancements to data validations are required to prevent and correct data errors and omissions.
12.   In collaboration with the study team and in line with COG policies and procedures, actively resolve data-related issues and queries that arise from the study site(s).
13.   Ensure Serious Adverse Events (SAE) reporting occurs per study specific protocol requirements, and within NCI guidance. Monitor consistency of serious adverse event data submissions versus submitted research data in EDC systems.
14.   Attend study team meetings, regularly provide study progress updates, and address any study related issues.
15.   Organize and coordinate sample logistics for correlative biology studies involving the study site(s), laboratories and study committee as necessary.
16.   Organize, coordinate, and monitor central reviews as determined by the protocol.
17.   Participate in presentations/discussions regarding data management via teleconferences and at COG Group meetings.

Requirements


Qualifications:

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 in a relevant field.
•   5 years of related experience.
•   Minimum 3 years of clinical research experience.
•   Experience as a Clinical Data Manager or Clinical Research Associate is preferred.  
•   Medidata RAVE, or similar EDC system study build experience is highly desirable.
•   Experience in a comprehensive cancer center, cooperative group or pharmaceutical/biotechnology industry is highly desirable.
•   Strong organizational skills with the ability to handle a variety of tasks and work independently.
•   High level of PC literacy is needed, including broad knowledge of Microsoft Office software (MS Word, Excel, PowerPoint and Access).
•   Excellent written and oral communication skills are essential.
•   Critical thinking and reasoning.

Compensation:

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.

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