clinical research data coordinator

Emory University

<div>Discover Your Career at Emory University:
<div>
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.</div>
Description:
<div><b>
About Winship Cancer Institute of Emory University</b></div><div></div><div><br>
Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia&rsquo;s only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient&rsquo;s needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope&reg;. For more information, visit winshipcancer.emory.edu.</div><div></div><div><b><br>
Winship is seeking qualified candidates for the Clinical Research Data Coordinator II position. </b><b>Position details are as follows:</b></div><div></div><div><br>
The Data Coordinator II, supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. Responsible for facilitating initial visit with study subject. Designs, builds, and maintains the functional operations of the database, ensuring accuracy and appropriate usage by all internal customers. Increases the functionality of the database to meet the needs of internal customers and members of the department. Manages complex projects related to data acquisition and tracking that are not related to a database. Analyzes subject data in relation to study protocol for entrance into study. Ensures data from source is entered in EDC per Sponsor contract expectations if not sooner. Facilitates study monitoring visits and prompt resolution of all study related queries.</div><div></div><div><br>
KEY RESPONSIBILITIES:
</div><ul><li>Primary Data Coordinator (DC) for complex interventional therapeutic clinical trials, including multi-center trials and WCI held Investigator Initiated Trials (IITs) in complex areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc.</li><li>
Independently responsible for all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
</li><li>Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including but not limited to industry, cooperative group, and investigator-initiated studies.
</li><li>Accurately captures and enters data into clinical trial databases as necessary, and within timelines set by study sponsors or CTO. Collects and maintains complete records and metrics on each research study participant. Consolidates clinical data and reports for investigators as needed.
</li><li>Assists in the review and evaluation of potential research studies and communicates effectively with CTO management and leadership regarding feasibility of proposed projects.
</li><li>Attends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management. Also provides support, ongoing education and updates to study team members, physicians, nurses, and other healthcare professionals regarding data-related protocol activities.
</li><li>Supports Data Team Supervisor in onboarding, training, and quality assurance of DC I position, as directed by DT Supervisor or Clinical Research Operations Manager (CROM).
</li><li>Serves as a resource to provide support and guidance to less experienced DCs and other study team members.
</li><li>Attends protocol related training meetings and completes all required study training.
</li><li>Liaises with sponsors and the in-house monitoring team, schedules monitoring visits, and addresses monitoring report findings.
</li><li>Leads the DC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
</li><li>Serves as the lead DC in preparing for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post audit.
</li><li>Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management. Provides support to Winship&Acirc;&iquest;s Informatics team as they develop and improve research information systems.
</li><li>Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies. Maintains controls to assure accuracy, completeness, and confidentiality of research data.
</li><li>Maintains confidentiality standards for all potential and enrolled patients; complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
</li><li>Performs other duties as assigned.
</li></ul><div>MINIMUM QUALIFICATIONS:
</div><ul><li>Bachelor Degree and at least two (2) years of clinical research data management experience OR High School Diploma or GED and at least six (6) years of clinical research data management experience OR an equivalent combination of education and experience.
</li></ul><div>PREFERRED QUALIFICATIONS:
</div><ul><li>Certification/license: ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire.</li></ul>
Additional Details:
<div>
Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).</div><div></div><div><br>
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.</div></div>

Clinical Research Data Coordinator II- Winship Cancer Institute

The START Center for Cancer Research

<div><p>The START Center for Cancer Research (&ldquo;START&rdquo;) is the world&rsquo;s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering &quot;Hope Through Access&rdquo; to cutting edge trials throughout the United States and Europe.<br>
<br>
We are hiring a motivated <b>Clinical</b> <b>Data Entry Coordinator </b>who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies.</p><p>
This position is offered at a pay range of <b>$24.00 to $27.00 per hour</b>, based on experience, qualifications, and internal equity. In addition, employees in this role may be eligible for an <b>annual bonus of up to 10%</b> of base earnings.</p><p><b>
Work Schedule: </b>8:00 am-5:00 pm EST, Monday-Friday</p><p><b>
Location:</b> 405 Lakeville Road, Entrance A, Lake Success, NY 11042</p><p><b>
Essential Responsibilities</b></p><ul><li>
Collect, enter/transcribe, and transmit/submit clinical data in paper and/or electronic case report forms (CRFs), including correction and query resolution for assigned investigational drug studies.</li><li>
Receive and request patient records/data from the study team as required to complete CRFs for assigned studies.</li><li>
Review patient data for completeness and accuracy for assigned studies.</li><li>
Coordinate and schedule monitor visits for assigned studies. This includes exit meetings with monitors to review data or queries.</li><li>
Identify lab facilities used for assigned studies and communicate to the Regulatory Affairs staff so that lab certifications can be requested for the study file.</li><li>
Review and utilize protocols as guides for study activities for assigned studies.</li><li>
Assure that data entry remains current for all assigned studies.</li><li>
Attend meetings as required for assigned studies. This includes, but is not limited to, site initiation meetings, monitor exit meetings, close-out visit meetings, and audit preparation meetings.</li><li>
Be available and on-site, if required, during audits for assigned studies.</li><li>
Communicate as needed with accounts receivable staff regarding submitted data.</li></ul><p><b>
Education &amp; Experience</b></p><ul><li>
Bachelor&rsquo;s degree or equivalent experience in lieu of degree.</li><li>
Knowledge and training in general office administration skills, including computer applications, filing systems, etc.</li></ul><p><b>
Preferred Education and Experience</b></p><ul><li>
Ability to accurately perform data review and CRF completion in its entirety with minimal direction.</li><li>
Familiarity with medical terminology.</li><li>
Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable.</li></ul><p><b>
Best-in-Class Benefits and Perks</b><br>
We value our employees&rsquo; time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:</p><ul><li>
Comprehensive health coverage: Medical, dental, and vision insurance provided</li><li>
Robust retirement planning: 401(k) plan available with employer matching</li><li>
Financial security: Life and disability insurance for added protection</li><li>
Flexible financial options: Health savings and flexible spending accounts offered</li><li>
Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided</li><li>
Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.</li></ul><p><b><br>
More about The START Center for Cancer Research</b><br>
Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world&rsquo;s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.<br>
<br>
<b>Ready to be part of a team changing the future of cancer treatment?</b><br>
Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.<br>
<br>
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.</p></div>

Clinical Data Entry Coordinator

University of Nebraska Medical Center

<div><div><h2 class="jobSectionHeader"><b>Requisition Details</b></h2>
<div><div><div>GENERAL REQUISITION INFORMATION
</div><p></p><div><div><div><div><b>EEO Statement:</b></div>
<div>UNMC is an Equal Employment Opportunity Employer, including an equal opportunity employer of protected veterans and individuals with disabilities.</div>
</div><br>
<div><div><b>Location</b></div> <div>Omaha, NE</div>
</div><br>
<div><div><b>Requisition Number:</b></div> <div>Staff_14641</div>
</div><br>
<div><div><b>Department</b></div> <div>Int Med Cardiovascular Med 50000584
</div></div><br>
<div><div><b>Business Unit</b></div> <div>College of Medicine</div>
</div><br>
<div><div><b>Reg-Temp</b></div> <div>Full-Time Regular</div>
</div><br>
<div><div><b>Work Schedule</b></div> <div>TBD by Supervisor and Responsibilities</div>
</div><br>
<div><div><b>Remote/Telecommuting</b></div> <div>No remote/telecommuting opportunity</div>
</div><br>
<div><div><b>Position Summary</b></div>
<div>Supports UNMC&rsquo;s Electrophysiology and Atrial Fibrillation programs by coordinating and maintaining a locally developed AFib registry. Works closely with EP faculty, APPs, nursing, EP lab staff, quality teams, and administration. Collaborates with the Principal Investigator on registry design, data integrity, regulatory oversight, and research initiatives. Serves as liaison with the IRB and plays a key role in implementing and maintaining a REDCap-based AF registry database.</div>
</div><br>
<div><div><b>Position Details</b></div>
<div><b>Additional Information</b></div>
</div><br>
<div><div><b>Posting Category</b></div> <div>Research - Non Academic</div>
</div><br>
<div><div><b>Working Title</b></div> <div>Data Coordinator II, Clinical Research</div>
</div><br>
<div><div><b>Job Title</b></div> <div>Data Coordinator L2</div>
</div><br>
<div><div><b>Salary Grade </b></div><div>RA22S</div>
</div><br>
<div><div><b>Appointment Type</b></div> <div>B1 - REG MGR PROF SALARY</div>
</div><br>
<div><div><b>Salary Range</b></div> <div>$53,000 - $79,500/annual</div>
</div><br>
<div><div><b>Job Requisition Begin Date</b></div> <div>04/07/2026</div>
</div><br>
<div><div><b>Application Review Date</b></div> <div>04/16/2026</div>
</div><br>
<div><div><b>Review Date Information:</b></div>
<div>Initial application review will begin on the date provided in the field above. Applications received prior to this review date will be considered. Applications received after the review date may be considered.</div>
</div><br>
</div></div></div><div><div>Required and Preferred Qualifications
</div><p></p><div><div><div><div><b>Required Education:</b></div> <div>Bachelor's degree or equivalent</div>
</div><br>
<div><div><b>If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major)</b></div>
<div>Health Science or related field<br>
(Will consider five years related education and/or experience combined of which two years must include related post high school education)</div>
</div><br>
<div><div><b>Required Experience</b></div> <div>1 year</div>
</div><br>
<div><div><b>If any experience is required, please specify what kind of experience:</b></div>
<div>Data collection or data management</div>
</div><br>
<div><div><b>Required License</b></div> <div>No</div>
</div><br>
<div><div><b>If yes, what is the required licensure/certification?</b></div>
<div>NA</div>
</div><br>
<div><div><b>Required Computer Applications:</b></div> <div>Microsoft Excel, Microsoft Word</div>
</div><br>
<div><div><b>Required Other Computer Applications:</b></div> <div>REDCap or equivalent electronic data capture system</div>
</div><br>
<div><div><b>Required Additional Knowledge, Skills and Abilities:</b></div>
<div>Exceptional attention to detail and organizational skills<br>
Ability to prioritize multiple tasks and manage deadlines<br>
Knowledge of clinical data abstraction and registry coordination<br>
Strong verbal and written communication skills<br>
Computer literacy including electronic data capture systems<br>
Ability to work independently and effectively with multi-disciplinary teams<br>
Strong interpersonal skills<br>
</div>
</div><br>
<div><div><b>Preferred Education:</b></div> <div>Bachelor's degree</div>
</div><br>
<div><div><b>If any degree/training is preferred, please specify the type:</b></div>
<div>Health science or related field</div>
</div><br>
<div><div><b>Preferred Experience:</b></div>
<div>Clinical data abstraction, registry coordination, or quality reporting; experience working with clinical databases or electronic data capture systems; strong proficiency with electronic medical records and data systems<br>
Cardiology or electrophysiology experience<br>
Clinical background (RN, CVT, or equivalent) strongly preferred<br>
Prior experience supporting or interacting with IRB processes<br>
Familiarity with REDCap or similar research data platforms<br>
Knowledge of basic biostatistical methods and outcomes analysis<br>
Experience in an academic medical center environment</div>
</div><br>
<div><div><b>Preferred License:</b></div> <div>No</div>
</div><br>
<div><div><b>If yes, what is the preferred licensure/certification?:</b></div>
<div>NA</div>
</div><br>
<div><div><b>Preferred Computer Applications:</b></div> <div>Microsoft Access, Microsoft PowerPoint, Microsoft Outlook</div>
</div><br>
<div><div><b>Preferred Other Computer Applications:</b></div> <div>Epic or equivalent EMR</div>
</div><br>
<div><div><b>Preferred Additional Knowledge, Skills and Abilities:</b></div>
</div><br>
<div></div><div><div><b>Email to a Friend</b></div> <div>https://unmc.peopleadmin.com/postings/97362</div></div></div></div></div></div></div></div><p></p>

Data Coordinator II, Clinical Research

<p></p><div><p>The START Center for Cancer Research (&ldquo;START&rdquo;) is the world&rsquo;s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval.</p><p>
The START Center for Cancer Research is seeking a <b>Clinical Data Entry Coordinator </b>who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies.</p><p><b>
Essential Responsibilities</b></p><ul><li>
Collect, enter/transcribe, and transmit/submit clinical data in paper and/or electronic case report forms (CRFs), including correction and query resolution for assigned investigational drug studies.
</li><li>Receive and request patient records/data from the study team as required to complete CRFs for assigned studies.
</li><li>Review patient data for completeness and accuracy for assigned studies.</li><li>
Coordinate and schedule monitor visits for assigned studies. This includes exit meetings with monitors to review data or queries.</li><li>
Identify lab facilities used for assigned studies and communicate to the Regulatory Affairs staff so that lab certifications can be requested for the study file.</li><li>
Review and utilize protocols as guides for study activities for assigned studies.
</li><li>Assure that data entry remains current for all assigned studies.
</li><li>Attend meetings as required for assigned studies. This includes, but is not limited to, site initiation meetings, monitor exit meetings, close-out visit meetings, and audit preparation meetings.
</li><li>Be available and on-site, if required, during audits for assigned studies.
</li><li>Communicate as needed with accounts receivable staff regarding submitted data.
</li></ul><p><b>Required Education and Experience:</b></p><ul><li>
Bachelor&rsquo;s degree or equivalent experience in lieu of degree.
</li><li>Knowledge and training in general office administration skills, including computer applications, filing systems, etc.</li></ul><p><b>
Preferred Education and Experience:</b></p><ul><li>
Ability to accurately perform data review and CRF completion in its entirety with minimal direction.
</li><li>Familiarity with medical terminology.</li><li>
Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable.
</li></ul><p><b>Physical &amp; Travel Requirements:</b></p><ul><li>
Travel required up to 10% of the time.</li><li>
Sitting for extended periods of time.</li><li>
Typing and computer use for extended periods of time.</li></ul><p><b>
Best-in-Class Benefits and Perks</b></p><p>
We value our employees&rsquo; time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:</p><ul><li>
Comprehensive health coverage: Medical, dental, and vision insurance provided</li><li>
Robust retirement planning: 401(k) plan available with employer matching</li><li>
Financial security: Life and disability insurance for added protection</li><li>
Flexible financial options: Health savings and flexible spending accounts offered</li><li>
Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided</li><li>
Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.</li></ul><p><b>
More about The START Center for Cancer Research</b></p><p>
Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world&rsquo;s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.</p><p><b>
Ready to be part of a team changing the future of cancer treatment?</b></p><p>
Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.</p><p>
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.</p></div><p></p>

Orlando Health

<div>Position Summary:
<p>
Department: Traumatic Brain Inj. Research<br>
Shift: Second (<b>2:30pm - 11:00pm</b>) /Full time <b>*** </b><b>No shift differential as it is grant-funded***</b></p><p><b>
Location: Orlando
</b></p><p><b>Title: Clinical Research Data Coord I
</b></p><p><b>Summary</b>:The Clinical Data Coordinator is responsible for the collection, abstraction, review, documentation and monitoring of data related to
<br>
clinical research projects.</p><p><br>
</p><p><b><i>&ldquo;</i></b><i>Orlando Health Is Your Best Place to Work&rdquo; is not just something we say, it&rsquo;s our promise to you.&rdquo;</i></p><p><i>
Orlando Health proudly embraces and honors the individuality of our team members. By sharing different ideas and perspectives and working together as a team, we are better able to relate to, care for and authentically serve our patients and families who make up the collective populations in our community. So, no matter who you are, what you believe or how you express yourself, you are welcome here.</i></p><p><b>
ORLANDO HEALTH - BENEFITS &amp; PERKS:</b></p><p><b>
Competitive Pay</b></p><ul><li>
Evening, nights, and weekend shift differentials offered for qualifying positions.</li></ul><p><b>
All Inclusive Benefits (start day one)</b></p><ul><li>
Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees.</li></ul><p><b>
Forbes Recognizes Orlando Health as a Best-In-State Employer</b></p><ul><li>
Forbes has named Orlando Health as one of America's Best-In-State Employers for 2021. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. <i>&quot;We are proud to be named once again as a best place to work,&quot;</i> said Karen Frenier, VP (HR). &quot;This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued.</li></ul><p><b>
Employee-centric</b></p><p>
Orlando Health has been selected as one of the &ldquo;Best Places to Work in Healthcare&rdquo; by Modern Healthcare.</p>
Responsibilities:
<div><b>
Essential Functions</b><br>
<ul><li>Responsible for working collaboratively with clinical research coordinators, regulatory coordinators, physicians, nurse clinicians,
</li></ul>pharmacy, and laboratory personnel to ensure tests/procedures/specimen collections, etc. are obtained per protocol.
<br>
<ul><li>Assist in the identification, collection and reporting of adverse events and serious adverse events in accordance with ICH, CFR, GCP
</li></ul>and protocol specific guidelines.
<br>
<ul><li>Prepare and provide patient status reports to leadership as requested</li><li>Serve as point of contact for respective sponsor monitoring visits</li><li>Ensure accurate and timely retrieval and submission of protocol driven data points from internal and external sources including but
</li></ul>not limited to data forms, study related materials (slides, pathology, operative reports, and radiology reports) to the relevant
<br>
cooperative or industry-based groups for patients placed on clinical trials.<br>
<ul><li>Participate in audits conducted by sponsors and other regulating authorities.
</li><li>Identify, research, resolve and report data discrepancies</li><li>Prepares new study patient charts</li><li>Maintains a registry of study patients at the relevant time points</li><li>Assists in the internal data quality and control process.
</li><li>Conduct survival follow up visits as applicable.
</li><li>Understanding of project management concepts in order to aid delivery across program</li><li>Ability to influence and communicate across functions and external stakeholders</li><li>Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state
</li></ul>and local standards.<br>
<ul><li>Maintains compliance with all Orlando Health policies and procedures.</li></ul><b>
Other Related Functions</b><br>
<ul><li>Attends appropriate departmental, corporate and continuing education meetings as required.
</li><li>Assumes the responsibility for professional growth and development.
</li><li>Transmits data to sponsoring and regulatory agencies.</li></ul></div>
Qualifications:
<div><b>
Education/Training</b><br>
<ul><li>Associates degree OR;</li><li>Bachelor&rsquo;s degree.</li><li><b>If no degree, experience may be substituted at a 2 for one ratio.</b>
</li><li>Experience with Microsoft Windows operating system and Microsoft Office to include Word, Excel, PowerPoint, and Access.</li><li>Previous experience working in a healthcare related or clinical research setting.</li><li>Previous oncology experience.</li></ul></div><div><b><br>
Licensure/Certification</b><br>
<ul><li>Orlando Health phlebotomy course within 30 days of hire is required within certain areas.</li></ul></div><div><b><br>
Experience</b><br>
Two (2) year&rsquo;s experience working with data or medical information to include quantitative duties such as data collection, management
<br>
and verification. Post-secondary education may offset experience on a 1 to 1 basis.</div></div>

Clinical Research Data Coord. - Full Time - Night - GRANT FUNDED ROLE

Georgetown University

<div><p>Georgetown University comprises two unique campuses in the nation&rsquo;s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.</p><p></p><p><b>
Requirements</b></p><p></p><p><b>
Job Overview</b></p><p></p><p>
The <b>Research Data Coordinator 1 </b>position is responsible for data management for phase I, II, and III oncology clinical trials conducted within the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). This position performs all duties in accordance with all applicable laws and regulations. Adheres to Georgetown University Medical Center&rsquo;s philosophies, policies, and SOPs. Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.</p><p></p><p>
Additional duties include, but are not limited to:</p><ul><li><p>
Responsible for supporting all aspects of clinical research data management for clinical trials conducted in the LCCC Clinical Research Management Office (CRMO), including collection of data from source documents and medical records and completion of case report forms per sponsor requirements.</p></li><li><p>
Responsible for trials of varying complexity and disease indication.</p></li><li><p>
Work collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team).</p></li><li><p>
Review and analyze information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including, but not limited to, industry, national, and investigator-initiated studies.</p></li><li><p>
Accurately capture data in electronic or paper Case Report Forms (eCRFs/CRFs) adhering to contractual timelines and site Standard Operating Procedures (SOPs).</p></li><li><p>
Ensure query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements.</p></li><li><p>
Request and upload radiological images into sponsor-provided imaging platforms according to each study protocol.</p></li><li><p>
Resolve imaging-related queries with the assistance of clinical study team.</p></li><li><p>
Collect and organize source documents in electronic and paper format according to site policies.</p></li><li><p>
Ensure accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates. Interface with study team members to resolve discrepancies.</p></li><li><p>
Schedule sponsor monitoring and study close-out visits.</p></li><li><p>
Provide support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.</p></li><li><p>
Communicate appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.</p></li><li><p>
Collaborate closely with physicians and Study Coordinators to maintain protocol integrity.</p></li><li><p>
Attend protocol-related training and complete all required study training in the required timeframe.</p></li><li><p>
Prepare for and participate in site initiation visits.</p></li><li><p>
Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations. Maintain controls to assure accuracy, completeness, and confidentiality of research data.</p></li><li><p>
Maintain confidentiality standards for all potential and enrolled study participants; comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.</p></li><li><p>
Other duties as assigned.</p></li></ul><p></p><p><b>
Work Interactions</b></p><ul><li><p>
Clinical Research Manager</p></li><li><p>
Disease Group members: Principal Investigators, Physicians, Clinicians</p></li><li><p>
Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians</p></li><li><p>
External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff</p></li><li><p>
Clinical trial sponsors, auditors, and study monitors</p></li></ul><p></p><p><b>
Requirements and Qualifications</b></p><ul><li><p>
High School Diploma or GED required.</p></li><li><p>
Up to two (2) years of related experience required.</p></li><li><p>
 Strong candidates exhibit:</p></li><li><p>
Ability to work independently and function within a team.</p></li><li><p>
Strong attention to detail.</p></li><li><p>
Reliable and able to prioritize competing responsibilities.</p></li></ul><p></p><p><b>
Work Mode Designation</b></p><p></p><p>
This position has been designated as<b> Hybrid 3 Days</b>. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position&rsquo;s mode of work designation. Complete details about Georgetown University&rsquo;s mode of work designations for staff and AAP positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.</p><p></p><p><b>
Pay Range:
</b></p><p>The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:</p>
$17.95 - $26.84<p></p><p>
Compensation is determined by a number of factors including, but not limited to, the candidate&rsquo;s individual qualifications, experience, education, skills, and certifications, as well as the University&rsquo;s business needs and external factors.</p><p></p><p><b>
Current Georgetown Employees:</b></p><p>
If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.</p><p></p><p><b>
Submission Guidelines:</b></p><p>
Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.</p><p></p><p><b>
Need Assistance:</b></p><p>
If you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.</p><p></p><p>
Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.</p><p></p><p>
EEO Statement:</p><p>
GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law<i>.</i></p><p></p><p>
Benefits:</p><p>
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.</p></div>

Research Data Coordinator 1

The University of Michigan

<p></p><div><div><div><h2 class="jobSectionHeader"><b>How to Apply</b></h2><p>
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.</p><h2 class="jobSectionHeader"><b>
Job Summary</b></h2><p>
This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 175 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.</p><p>
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.</p><h2 class="jobSectionHeader"><b>
Responsibilities*</b></h2><p>
Characteristic Duties and Responsibilities:</p><p>
Independent knowledge, skills, and abilities within all 8 competency domains is expected:</p><ul><li>
Scientific Concepts and Research Design</li><li>
Ethical Participant Safety Considerations</li><li>
Investigational Products Development and Regulation</li><li>
Clinical Study Operations (GCPs)</li><li>
Study and Site Management</li><li>
Data Management and Informatics</li><li>
Leadership and Professionalism</li><li>
Communication and Teamwork</li></ul><p>
This position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.</p><p>
Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Data. Examples of duties a successful candidate in this role will perform:</p><p><b>
Clinical Research Coordinator - Associate</b></p><ul><li>
Demonstrates the ability to document data in accordance with ALCOA-C principles.</li><li>
Explains how to utilize information from the EMR and study databases.</li><li>
Completes complex data collection during study visits.</li><li>
Demonstrates ability to resolve data queries.</li><li>
Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.</li><li>
Schedules, assists with preparation for, and attends study initiations meetings, monitor visits, and audits.</li></ul><p><b>
Clinical Research Coordinator - Technician</b></p><p>
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.</p><ul><li>
Completes simple to moderately complex CRFs.</li><li>
Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC).</li><li>
Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.</li></ul><p><b>
Clinical Research Coordinator - Assistant</b></p><p>
This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.</p><ul><li>
Demonstrates the ability to complete simple data collection during study visits (e.g., basic demographic information).</li><li>
Enters data to complete forms (CRFs) on paper, databases, or EDCs.</li><li>
Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs, as assigned.</li><li>
May administrator minimal risk consents, surveys, and questionnaires.</li><li>
Checks own work and confirms accuracy.</li><li>
Demonstrates ability to perform concomitant medications abstraction.</li><li>
Uses various NCI AE grading scales.</li><li>
Builds patient research study charts.</li><li>
Demonstrates ability to resolve simple queries.</li><li>
Assists in quality control efforts (e.g., review of consents for signatures).</li></ul><h2 class="jobSectionHeader"><b>
Required Qualifications*</b></h2><p><b>
Clinical Research Coordinator - Associate</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.</li><li>
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professional (CCRP) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.</li><li>
Minimum of 2 years directly related experience in clinical research and clinical trials is necessary.</li></ul><p><b>
Clinical Research Coordinator - Technician</b></p><ul><li>
Associate degree in health science or an equivalent combination of related education and experience is necessary.</li><li>
Minimum 1 year directly related experience in clinical research and clinical trials is necessary or an advanced degree in a health-related area such as Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD or minimum 3 years of human subject experience (clinical, lab, or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.</li></ul><p><b>
Clinical Research Coordinator - Assistant</b></p><ul><li>
High School Diploma or GED is necessary.</li></ul><h2 class="jobSectionHeader"><b>
Desired Qualifications*</b></h2><p><b>
Clinical Research Coordinator - Associate</b></p><ul><li>
4+ years of direct related experience.</li></ul><p><b>
Clinical Research Coordinator - Technician</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is desirable.</li><li>
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.</li></ul><p><b>
Clinical Research Coordinator - Assistant</b></p><ul><li>
Associate degree in health science or an equivalent combination of related education and experience is desirable.</li><li>
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.</li></ul><h2 class="jobSectionHeader"><b>
Why Join Michigan Medicine?</b></h2><p>
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.</p><p><b>
What Benefits can you Look Forward to?</b></p><ul>
<li>Excellent medical, dental and vision coverage effective on your very first day</li>
<li>2:1 Match on retirement savings</li></ul><h2 class="jobSectionHeader"><b>
Modes of Work</b></h2><p>
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.</p><h2 class="jobSectionHeader"><b>
Work Schedule</b></h2><p>
Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines or support patient care.</p><h2 class="jobSectionHeader"><b>
Underfill Statement</b></h2><p>
This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.</p><h2 class="jobSectionHeader"><b>
Background Screening</b></h2><p>
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.</p><h2 class="jobSectionHeader"><b>
Application Deadline</b></h2><p>
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.</p><h2 class="jobSectionHeader"><b>
U-M EEO Statement</b></h2><p>
The University of Michigan is an equal employment opportunity employer.</p></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Job Opening ID</b></h3>
<div><p>276036</p>
</div></div><div><h3 class="jobSectionHeader"><b>Working Title</b></h3>
<div><p>Clinical Research Coord Associate/ Technician/ Assistant</p>
</div></div><div><h3 class="jobSectionHeader"><b>Job Title</b></h3>
<div><p>Clinical Research Coord Assoc</p>
</div></div><div><h3 class="jobSectionHeader"><b>Work Location</b></h3>
<div><p>Ann Arbor Campus</p>
</div></div><p>Ann Arbor, MI</p>
<div><h3 class="jobSectionHeader"><b>Modes of Work</b></h3>
<div><p>Hybrid
</p></div></div><div><h3 class="jobSectionHeader"><b>Full/Part Time</b></h3>
<div><p>Full-Time</p>
</div></div><div><h3 class="jobSectionHeader"><b>Regular/Temporary</b></h3>
<div><p>Regular</p>
</div></div><div><h3 class="jobSectionHeader"><b>FLSA Status</b></h3>
<div><p>Nonexempt</p>
</div></div><div><h3 class="jobSectionHeader"><b>Organizational Group</b></h3>
<div><p>Medical School</p>
</div></div><div><h3 class="jobSectionHeader"><b>Department</b></h3>
<div><p>MM O-CTSU Study Coord Data</p>
</div></div><div><h3 class="jobSectionHeader"><b>Posting Begin/End Date</b></h3>
<div><p>4/09/2026 - 4/30/2026</p>
</div></div><div><h3 class="jobSectionHeader"><b>Career Interest</b></h3>
<div><p>Research</p></div></div></div>

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