Research Coordinator I (REDCap)
Posting Number: #1316
Position Title: Research Coordinator I (REDCap)
Closing Date: Until Filled
Location: Remote, USA
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 Research Coordinator (RC) serves as the REDCap® data management specialist for all assigned COG trials. This position is responsible for coordinating all aspects of data acquisition and management for assigned COG studies under the direction of the Study Chair, Lead Investigator, Study Statistician, COG/Scientific Committee leadership, and other staff responsible for implementing and conducting COG studies. This involves developing databases and implementing Case Report Forms (CRFs) in REDCap®, data validations, and data management plans (DMP) for assigned COG studies. It also involves monitoring the quality and timeliness of submitted study research data, overseeing patient enrollments/randomizations, conducting data cleaning activities, coordinating central reviews within Electronic Data Capture systems (EDC), and creating custom data reports for all assigned studies. The Research Coordinator is also required to amend CRFs/study databases per study needs, implementing the corresponding changes in the EDC system and DMP. The Research Coordinator will collaborate with the scientific, administrative, and study committees to ensure successful conduct of NCORP research. The position will also assist with various projects under the umbrella of the NCORP and core operations for COG Clinical Trials.
Pay: $23.94 to $28.82 per hour. The typical hiring range for this position is $23.94 to $28.82 per hour (with an approximate annualized salary of $49,800 to $59,955 based on 100% FTE). The starting wage is determined based on the candidate’s knowledge, skills, and experience.
Employment Type: Full Time
Essential Duties & Responsibilities
- Review and provide feedback on study protocols, especially section(s) pertaining to Patient Reported Outcome data collection and data management, ensuring that the database is designed to accurately capture the data required to meet the study aims.
- Design the database/CRFs and data validations (i.e., edit checks) required for assigned COG studies in collaboration with study team, ensuring consistency with the protocol, consent form documents, and compliance with internal standard operating procedures (SOPs).
- Coordinate with the study team on study development 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.
- Create common data elements (CDEs) to capture essential research data for the study.
- Circulate draft database/CRFs for review by study steam, and lead review meeting calls presenting potential data collection and/or management issues.
- Create an integrated study development and data management plan (DMP) in conjunction with other study RCs and study team members.
- Review protocol amendments to determine if changes to the database/CRFs and/or study DMP are necessary. Coordinate with study team on amendment timelines and site communications.
- If necessary, with protocol amendments, draft database/CRF changes and coordinate appropriate review and approvals, discussing updates with study team, and implementing finalized changes in revised database/CRFs.
- Maintain and monitor the conduct of existing trials within REDCap, including managing patient enrollments/randomizations and opening, closing, or suspending studies, as required, according to established departmental SOPs and study DMPs.
- Build custom data reports based upon study committee requests and protocol requirements.
- 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.
- 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).
- Attend study team meetings, regularly provide study progress updates, and address any study related issues.
- Work with IT staff to address technical data collection problems.
- Develop and maintain Standard Operating procedures to manage workflow.
- Perform other duties as assigned.
- Minimum 2 years of clinical research experience.
- Bachelor’s degree in a related field, or you can substitute with four additional years of relevant experience.
- High level of REDCap® literacy.
- Experience as a Clinical Data Manager or Clinical Research Associate is preferred.
- 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.
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Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, it is a condition of employment for all domestic based employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law.
New hires need to provide proof of full vaccination prior to their start date or apply for an exemption/accommodation within three business days after their start date. Depending on the circumstances, new hires who do not comply with this Policy, or who cannot be reasonably accommodated, will either have their employment suspended or terminated. Candidates who are non-compliant will have their offers rescinded.
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