Manager of Research Coordinators
PHI is seeking a full time Manager of Research Coordinators for the Children's Oncology Group (COG). This position is located in Monrovia, CA.
The Manager of Research Coordinators is responsible for leading the data management activities for COG and managing Research Coordinators (RCs) in the COG Data Center (Monrovia and Gainesville offices), as well as all aspects of study coordination and data acquisition for a group of COG studies. As the RC Manager, the individual is responsible for reviewing and assigning COG studies to RCs, monitoring RC work flow, working with the Sr. Director of the SC to outline process improvement plans/best practices and participating in leadership meetings. The RC III works with the Director of Data Operations to understand the nuances of all applications that are used in day to day activities.
As a manager of a group of COG studies, the individual is the primary contact for each study in the portfolio between the Data Center and COG institutional participants in the study, members of the study committee, the Statistics Department, the Study Development Office (SDO), other COG administrative offices, the Information Technology (IT) Department, and the clinical, laboratory, and resource center staff responsible for performing COG studies. The individual will participate in all data management study start up and close out activities, and during the course of the study for data cleaning and organizing data cleaning efforts. This entails coordination of data collection from institutional investigators, laboratory researchers and study committee members as well as preparation of ad-hoc reports as needed.
Duties &
Responsibilities:
Monitor workloads and assign studies and projects to RCs based upon COG priorities.
Monitor workflow for RCs including CRF development, Data Cleaning, AE/SAE reconciliation as well as interactions with institutional representatives.
Oversee/perform CRF design, data management plan (DMP), including guidelines for CRF completion, data review, AE/SAE reconciliation, data validations in collaboration with the study statistician, Rave study builder, and study committee.
When necessary, modify or enhance data validations to prevent and correct data errors and omissions that have been identified.
Oversee/perform the creation of data elements CDEs as needed to capture essential research data for the study.
Participate in user acceptance testing (UAT).
Generate/review specifications for data review listings.
Perform/coordinate reconciliation of CRF adverse events data.
Perform data review periodically for quality issues and general data trends; generate queries as necessary.
Help to establish data management SOPs and guidelines.
Create and produce data reports to facilitate clinical data management processes.
Work with the CRA discipline committee to resolve issues and enhance communication.
Prepare/participate in presentations/discussions regarding areas of interest for the CRA discipline committee at COG annual Group meetings if needed.
Review sections of study protocols related to patient treatment, supportive care, specimen submission, patient follow-up, and any other sections requiring understanding of clinical or laboratory aspects of COG studies.
Manage the conduct of studies including, but not limited to, monitoring patient enrollments and randomizations and closing or suspending studies as determined by protocol design or Study Chair to ensure patient safety for both legacy (RDE-1/eRDES) and OPEN/Rave trials. Create and execute the Study Data Review Plan.
Monitor the quality of submitted research data through the eRDES reporting module to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data as well as OPEN/Rave trials.
Oversee/perform and monitor systems for rapid tracking and reporting of dose-limiting toxicities, toxic deaths, severe adverse events (SAEs), treatment failures, or other critical study endpoints, as appropriate for the study.
Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.
Work with IT staff to address technical problems or system enhancements affecting data systems.
Qualifications:
Bachelor's degree required. Graduate degree in a science-related field preferred.
Five years related experience.
Minimum three years' experience as a CRA, CDM or equivalent combination of experience and education credits.
Experience as a CRA/CDM in a comprehensive cancer center, cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
Certification as a Clinical Data Manager (CDM) highly desirable. (CCDM or other reputable industry certification for clinical data management).
High level of PC literacy is required, including intermediate to advanced knowledge of Microsoft Office software such as MS Word, Excel and Access.
Excellent written and oral communication skills are essential.
Compensation:
This is a non-exempt position and the hourly wage 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.
We are proud to be an EEO/AA Employer
NO PHONE CALLS PLEASE
Estimated Salary: $20 to $28 per hour based on qualifications.
The Manager of Research Coordinators is responsible for leading the data management activities for COG and managing Research Coordinators (RCs) in the COG Data Center (Monrovia and Gainesville offices), as well as all aspects of study coordination and data acquisition for a group of COG studies. As the RC Manager, the individual is responsible for reviewing and assigning COG studies to RCs, monitoring RC work flow, working with the Sr. Director of the SC to outline process improvement plans/best practices and participating in leadership meetings. The RC III works with the Director of Data Operations to understand the nuances of all applications that are used in day to day activities.
As a manager of a group of COG studies, the individual is the primary contact for each study in the portfolio between the Data Center and COG institutional participants in the study, members of the study committee, the Statistics Department, the Study Development Office (SDO), other COG administrative offices, the Information Technology (IT) Department, and the clinical, laboratory, and resource center staff responsible for performing COG studies. The individual will participate in all data management study start up and close out activities, and during the course of the study for data cleaning and organizing data cleaning efforts. This entails coordination of data collection from institutional investigators, laboratory researchers and study committee members as well as preparation of ad-hoc reports as needed.
Duties &
Responsibilities:
Monitor workloads and assign studies and projects to RCs based upon COG priorities.
Monitor workflow for RCs including CRF development, Data Cleaning, AE/SAE reconciliation as well as interactions with institutional representatives.
Oversee/perform CRF design, data management plan (DMP), including guidelines for CRF completion, data review, AE/SAE reconciliation, data validations in collaboration with the study statistician, Rave study builder, and study committee.
When necessary, modify or enhance data validations to prevent and correct data errors and omissions that have been identified.
Oversee/perform the creation of data elements CDEs as needed to capture essential research data for the study.
Participate in user acceptance testing (UAT).
Generate/review specifications for data review listings.
Perform/coordinate reconciliation of CRF adverse events data.
Perform data review periodically for quality issues and general data trends; generate queries as necessary.
Help to establish data management SOPs and guidelines.
Create and produce data reports to facilitate clinical data management processes.
Work with the CRA discipline committee to resolve issues and enhance communication.
Prepare/participate in presentations/discussions regarding areas of interest for the CRA discipline committee at COG annual Group meetings if needed.
Review sections of study protocols related to patient treatment, supportive care, specimen submission, patient follow-up, and any other sections requiring understanding of clinical or laboratory aspects of COG studies.
Manage the conduct of studies including, but not limited to, monitoring patient enrollments and randomizations and closing or suspending studies as determined by protocol design or Study Chair to ensure patient safety for both legacy (RDE-1/eRDES) and OPEN/Rave trials. Create and execute the Study Data Review Plan.
Monitor the quality of submitted research data through the eRDES reporting module to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data as well as OPEN/Rave trials.
Oversee/perform and monitor systems for rapid tracking and reporting of dose-limiting toxicities, toxic deaths, severe adverse events (SAEs), treatment failures, or other critical study endpoints, as appropriate for the study.
Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.
Work with IT staff to address technical problems or system enhancements affecting data systems.
Qualifications:
Bachelor's degree required. Graduate degree in a science-related field preferred.
Five years related experience.
Minimum three years' experience as a CRA, CDM or equivalent combination of experience and education credits.
Experience as a CRA/CDM in a comprehensive cancer center, cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
Certification as a Clinical Data Manager (CDM) highly desirable. (CCDM or other reputable industry certification for clinical data management).
High level of PC literacy is required, including intermediate to advanced knowledge of Microsoft Office software such as MS Word, Excel and Access.
Excellent written and oral communication skills are essential.
Compensation:
This is a non-exempt position and the hourly wage 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.
We are proud to be an EEO/AA Employer
NO PHONE CALLS PLEASE
Estimated Salary: $20 to $28 per hour based on qualifications.
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