Sr Clinical Trials Data Coord

Remote Full-time
%3Cdiv class=%22block__cell block__field--wide-rich-text%22 style=%22-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);box-sizing:border-box;color:rgb(0, 0, 0);flex:0 1 100%;font-family:%26quot;Open Sans%26quot;, %26quot;Segoe UI%26quot;, Frutiger, %26quot;Frutiger Linotype%26quot;, %26quot;Dejavu Sans%26quot;, %26quot;Helvetica Neue%26quot;, Arial, sans-serif;font-size:13.02px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:400;letter-spacing:normal;margin:10px 0px 0px;orphans:2;padding:0px 25px 0px 0px;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;width:985.4px;word-spacing:0px;%22 data-bind=%22css: %24component.getBlockCellCss(%24data, 0)%22%3E%3Cdiv class=%22block__field--wide-rich-text%22 style=%22flex-basis:100%;%22 data-bind=%22attr: {id: %24data.name + %27-container%27,%0A class:(%0A %24data.displayType === %27InputTextArea%27) ? %27block__field--full-width%27 : %0A (%24data.displayType === %27InputRichText%27 || %24data.name === %27descriptionExt%27 || %24data.name === %27qualificationExt%27 ||%0A %24data.name === %27descriptionInt%27 || %24data.name === %27qualificationInt%27) ? %27block__field--wide-rich-text%27 :%0A %27block__field--edit%27}%22 id=%22descriptionExt-container%22%3E%3Cdiv class=%22oj-form-control block__field-rtfValue %22 style=%22margin-bottom:5px;padding-bottom:5px;vertical-align:middle;%22 data-bind=%22attr: {id: %24data.name + %27-value%27, formFieldId: %24data.name},%0A html: %24component.getFieldValue(%24data)%22 id=%22descriptionExt-value%22 formfieldid=%22descriptionExt%22%3E%3Cp style=%22margin:0px 0px 12px;%22%3E%3Cspan style=%22color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan data-olk-copy-source=%22MailCompose%22%3EJoin the transformative team at %3C/span%3E%3C/span%3E%3Ca class=%22x_x_x_OWAAutoLink%22 style=%22color:rgb(4, 95, 171);line-height:inherit;margin-bottom:0px;margin-top:0px;text-decoration:none;%22 href=%22 id=%22OWA51d855f6-f966-6d8f-2f7b-483a2d973eb2%22 data-auth=%22NotApplicable%22%3E%3Cspan style=%22color:rgb(4,95,171);font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3ECity of Hope%3C/span%3E%3C/a%3E%3Cspan style=%22color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E, where we%27re changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. 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. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.%26nbsp;%3C/span%3E%3C/p%3E%3Cp style=%22margin:0px 0px 12px;%22%3E%3Cspan style=%22color:rgb(0,0,0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;%22%3E%26nbsp;%3C/span%3E%3C/p%3E%3Cp style=%22margin:0px 0px 12px;%22%3E%3Cspan style=%22color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3EThe Senior Clinical Trials Data Coordinator supports complex oncology clinical trials from First-in-Human and Phase I through Phase IV by coordinating data collection, entry, quality assurance, and query resolution to ensure accurate, reliable, and compliant research data. The role involves interpreting research protocols, reviewing medical records, resolving discrepancies, and maintaining study visits and financial triggers within the Clinical Trial Management System (CTMS) aligned with Electronic Data Capture (EDC) systems. Working closely with physicians, clinical coordinators, and research teams, the coordinator ensures timely data reporting, supports adverse event data collection, and contributes to study monitoring and regulatory compliance. Additionally, the role includes performing peer data reviews, assisting in the development of data management plans and workflows, and providing training and guidance to research data staff to maintain high-quality clinical trial data and efficient research operations.%3C/span%3E%3C/p%3E%3Cp style=%22margin:0px 0px 12px;%22%3E%3Cspan style=%22color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cstrong%3EAs a successful candidate, you will:%3C/strong%3E%26nbsp;%3C/span%3E%3C/p%3E%3Cul style=%22margin:12px 0px;padding:revert;%22%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3EEnter and manage clinical trial data in EMR, CTMS (OnCore), and EDC systems within required timelines while supporting studies from start-up through closeout.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3EEnsure data accuracy, completeness, and compliance through quality checks, data cleaning, and timely resolution of queries.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3EMaintain regulatory compliance with FDA, ICH-GCP, ALCOA+, HIPAA, and other applicable guidelines for clinical research data management.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3ECollaborate with sponsors, physicians, and clinical coordinators to resolve protocol issues, data discrepancies, and ensure proper documentation.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3EManage adverse event documentation and classification using standard dictionaries such as MedDRA, CTCAE, and WHO-DDE, including SAE follow-up and query resolution.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3EMaintain study calendars, financial triggers, and data completion tracking in CTMS to support billing and study financial management.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3ESupport monitoring visits, study initiation visits, audits, and inspection readiness, ensuring data quality and completeness.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli style=%22color:rgb(0, 0, 0);font-family:Aptos, Aptos_EmbeddedFont, Aptos_MSFontService, Calibri, Helvetica, sans-serif;font-size:12pt;line-height:1.25;%22%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cspan role=%22presentation%22%3EContribute to data management improvements by assisting with EDC builds, creating data standards, preparing reports, participating in CAPA and process improvement initiatives, and mentoring peers.%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3C/div%3E%3C/div%3E%3C/div%3E%3Cdiv class=%22block__field--line-break%22 style=%22-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);color:rgb(0, 0, 0);flex-basis:100%;font-family:%26quot;Open Sans%26quot;, %26quot;Segoe UI%26quot;, Frutiger, %26quot;Frutiger Linotype%26quot;, %26quot;Dejavu Sans%26quot;, %26quot;Helvetica Neue%26quot;, Arial, sans-serif;font-size:13.02px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:400;height:0px;letter-spacing:normal;orphans:2;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;word-spacing:0px;%22%3E%26nbsp;%3C/div%3E%3Cdiv class=%22block__cell block__field--wide-rich-text%22 style=%22-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);box-sizing:border-box;color:rgb(0, 0, 0);flex:0 1 100%;font-family:%26quot;Open Sans%26quot;, %26quot;Segoe UI%26quot;, Frutiger, %26quot;Frutiger Linotype%26quot;, %26quot;Dejavu Sans%26quot;, %26quot;Helvetica Neue%26quot;, Arial, sans-serif;font-size:13.02px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:400;letter-spacing:normal;margin:10px 0px 0px;orphans:2;padding:0px 25px 0px 0px;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;width:985.4px;word-spacing:0px;%22 data-bind=%22css: %24component.getBlockCellCss(%24data, 0)%22%3E%3Cdiv class=%22block__field--wide-rich-text%22 style=%22flex-basis:100%;%22 data-bind=%22attr: {id: %24data.name + %27-container%27,%0A class:(%0A %24data.displayType === %27InputTextArea%27) ? %27block__field--full-width%27 : %0A (%24data.displayType === %27InputRichText%27 || %24data.name === %27descriptionExt%27 || %24data.name === %27qualificationExt%27 ||%0A %24data.name === %27descriptionInt%27 || %24data.name === %27qualificationInt%27) ? %27block__field--wide-rich-text%27 :%0A %27block__field--edit%27}%22 id=%22qualificationExt-container%22%3E%3Coj-label class=%22block__field-label oj-label oj-component oj-complete%22 style=%22color:rgb(132, 132, 132);display:block;font-size:0.929rem;font-weight:normal;margin-bottom:0.25em;overflow-wrap:break-word;word-break:break-word;%22 data-bind=%22attr: {for: %24data.name + %27-value%27, style : %24data.labelStyle }%22 for=%22qualificationExt-value%22 id=%22ui-id-2598%22%3E%3Cdiv class=%22oj-label-group%22 style=%22display:inline-block;vertical-align:bottom;%22%3E%3Clabel class=%22oj-component-initnode%22 data-oj-internal=%22%22 id=%22ui-id-2598|label%22 for=%22qualificationExt-value%22%3E%3Cspan style=%22color:rgb(0, 0, 0);font-family:%26quot;helvetica neue%26quot;, arial, verdana, sans-serif;font-size:0.929rem;font-style:normal;font-weight:bold;text-decoration:none;%22 data-bind=%22html: %24component.getLabel(%24data)%22%3EQualifications - External%3C/span%3E%3C/label%3E%3C/div%3E%3C/oj-label%3E%3Cdiv class=%22oj-form-control block__field-rtfValue %22 style=%22margin-bottom:5px;padding-bottom:5px;vertical-align:middle;%22 data-bind=%22attr: {id: %24data.name + %27-value%27, formFieldId: %24data.name},%0A html: %24component.getFieldValue(%24data)%22 id=%22qualificationExt-value%22 formfieldid=%22qualificationExt%22%3E%3Cp style=%22margin:0px;%22%3E%26nbsp;%3C/p%3E%3C/div%3E%3C/div%3E%3C/div%3E Your qualifications should include: Minimum Education Bachelor’s degree in Science, Health, or a related field from an accredited university, or equivalent relevant work experience. Minimum Experience : Minimum of 5–7 years of clinical research or related experience. Required Certifications: Completion of Good Clinical Practice (GCP) training within 1 month of employment. Completion of Human Subjects Protection (HSP) training within 1 month of employment. Ability to obtain SOCRA or ACRP certification within 2 years of employment. Systems Knowledge: Experience with Clinical Trial Management Systems (CTMS), Electronic Medical Records (EMR), and eRegulatory systems. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here . To learn more about our Comprehensive Benefits, please CLICK HERE .
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