clinical data coordinator

Caris Life Sciences

<div>At Caris, we understand that cancer is an ugly word&mdash;a word no one wants to hear, but one that connects us all. That&rsquo;s why we&rsquo;re not just transforming cancer care&mdash;we&rsquo;re changing lives. 
We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: &ldquo;What would I do if this patient were my mom?&rdquo; That question drives everything we do. 
But our mission doesn&rsquo;t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare&mdash;driven by innovation, compassion, and purpose. 
Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
Position Summary
The Clinical Data Coordinator is responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position will ensure the highest standards for clinical data integrity and quality are maintained in alignment with critical research efforts aimed to improve the treatment, health and medical outcomes for oncology patients. Responsible for the collection and review of clinical protocol research data; Interpretation of data (including appropriate source documentation) for entry into computerized databases; Good understanding of data definitions and case report forms and other information related to data collection for clinical research. Must respond to queries in a timely fashion. Schedule on-site visits to perform data review and EDC data entry.
Job Responsibilities
<ul><li>Abstract clinical data from subject source documentation.
</li><li>Enter clinical data into the study specific EDC case report forms.
</li><li>Clean the clinical data to verify accuracy.
</li><li>Update the EDC following verification of subject data, including the resolution of data queries.
</li><li>Track site goals and case report form completion.
</li><li>Prioritize site cases for analysis.
</li><li>Maintain study specific documentation.
</li><li>Perform QC audits of the clinical database.
</li><li>Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPAA regulations, Site Operating Procedures and ethical standards for the conduct of research clinical trials.
</li><li>Work closely with onsite team to confirm appropriate consenting is being performed and documented prior to data abstraction.
</li><li>Maintain to Caris and Site requirements for source document management and request for information.
</li><li>Act as site designated entry person.
</li><li>Willingness to travel to multiple investigative sites if required.
</li><li>Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff.
</li></ul>Required Qualifications
<ul><li>Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment.
</li><li>Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations.
</li><li>Clinical study experience in the field of Oncology.
</li><li>Strong medical terminology understanding.
</li><li>Experience in both small and large scale project planning and reporting with strong communication and presentation skills.
</li><li>Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues.
</li><li>Experience with EDC systems.
</li><li>Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use .
</li></ul>Physical Demands
<ul><li>Must possess ability to sit and/or stand for long periods of time.
</li></ul>Training
<ul><li>All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
</li></ul>Other
<ul><li>This position may require occasional evenings and overtime.
</li></ul>Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions ) and reference verification.
This job description reflects management&rsquo;s assignment of essential functions. Nothing in this job description restricts management&rsquo;s right to assign or reassign duties and responsibilities to this job at any time. 
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.</div>

Clinical Data Coordinator I

Indiana University

<div>Department
CANCER CENTER (IN-CANC-IUINA)
Department Information
The mission of the Indiana University (IU) Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up.
Job Summary<ul><li>
Assists in the conduct of clinical research studies or trials following established protocols and standard operating procedures.</li><li>
Assists with identifying and recruiting subjects for clinical research studies or trials; calls/schedules subjects for appointments per protocol; performs screening, consenting and interviewing/data collection in adherence with the assigned study protocol and in accordance with good clinical principals; collects patient consent and authorization for treatment intervention documents and performs those interventions as needed.</li><li>
Conducts routine experiments and/or coordinates research study procedures in accordance with SOPs; receives, collects, and records study data in database; communicates and keeps researchers and/or PI up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures.</li><li>
Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families.</li><li>
Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits.</li><li>
Maintains and manages inventory and research study supplies; may be responsible for facilitating disbursement of study participant payments.</li><li>
Provides various additional research study support (such as protocol research in medical library/online databases, summarizing literature reviews for study hypothesis, grant preparation, manuscript review/editing, literature searches, and/or transcription).</li><li>
Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.</li></ul>
Qualifications
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION
Required<ul><li>
High school diploma or equivalent (such as HSED or GED) plus 5 years patient-related or research experience that includes 2 years of experience with clinical studies; OR</li><li>
Associate's degree in allied health profession plus 1 year of patient-related or research experience; OR</li><li>
Bachelor's degree in any field or 3 years of college-level science plus 2 years of patient-related or research experience; OR</li><li>
Bachelor's degree in science or health-related field</li></ul>
SKILLS
Required<ul><li>
Proficient written and verbal communication skills.</li><li>
Maintains a high degree of professionalism.</li><li>
Demonstrates time management and priority setting skills.</li><li>
Demonstrates a high commitment to quality.</li><li>
Possesses flexibility to work in a fast paced, dynamic environment.</li><li>
Highly thorough and dependable.</li></ul>
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
IUSCCC Clinical Trials Office
IU Indianapolis Campus
Indianapolis, Indiana
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:<ul><li>
Comprehensive medical and dental insurance</li><li>
Health savings account with generous IU contributions</li><li>
Healthcare and dependent care flexible spending accounts</li><li>
Basic group life insurance paid by IU</li><li>
Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance</li><li>
Base retirement plan with generous IU contributions, subject to vesting</li><li>
Voluntary supplemental retirement plan options</li><li>
Tuition subsidy for employees and family members taking IU courses</li><li>
10 paid holidays plus a paid winter break each year</li><li>
Generous paid time off plans</li><li>
Paid leave for new parents and IU-sponsored volunteer events</li><li>
Employee assistance program (EAP)</li></ul>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Intermediate
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research 
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.
Contact Us
Request Support 
Telephone: 812-856-1234</div>

Clinical Data Coordinator (Clinical Research Technician)

STARS Behavioral Health Group

<div><h1 class="jobSectionHeader">Partner with us in making a positive change!</h1>
Join a team where your work truly matters. We're proud to have been certified as a Great Place to Work for 8 years by our own employees. We invite you to partner with us in our mission to improve mental healthcare.
Job Title:
Clinical Data &amp; Housing Coordinator
Division/Program:
Allocation - Administration Sacramento
Starting Compensation:
23.16 - 27.79 USD Per Hour
Working Location:
Sacramento: Downtown Center (In-person position)
Working Hours/Shift:
FT, Monday-Friday, AM Shift (9 am -5:30 pm)
Why Join Our Team?<ul><li>
Competitive Compensation: Offering a salary that matches your skills and experience.</li><li>
Generous Time Off: Enjoy ample vacation and holiday pay.</li><li>
Comprehensive Benefits Package:</li><li><ul><li>
Employer-paid medical, dental, and vision coverage.</li><li>
Additional voluntary benefits to support your lifestyle.</li></ul></li><li>
Professional Growth Opportunities:</li><li><ul><li>
On-the-job training with access to paid CEU opportunities.</li><li>
Career development programs designed to help you grow.</li><li>
Supervision for BBS hours for AMFT, ACSW, and APCC professionals (where applicable).</li></ul></li></ul>
Employee Recognition &amp; Rewards: A culture that celebrates and rewards your hard work and dedication
What you bring to SBHG (qualifications):<ul><li>
Five (5) years of experience in a behavioral health setting or in a social service field; OR</li><li>
Bachelor&rsquo;s degree and one (1) year of experience in a behavioral health setting or in a social service field</li><li>
Personal experience as a consumer in the child welfare, probation, or mental health systems, preferred.</li><li>
Valid California Driver's License.</li></ul>
How you will make a difference (job overview):
This position&rsquo;s primary role is to support youth and programs with data administration and linkage to unhoused community programs and resources. The Clinical Data Coordinator is primarily responsible for partnering with program resource specialists to ensure access to housing resources, county housing programs, attending case conferencing meetings, collaboration meetings, and providing education/information about housing needs to community stakeholders.
Division/Program Overview:
<ul><li>Robust admin team</li><li>
Supports 4 community-based programs and one residential</li><li>
Planned referrals and walk-in&rsquo;s are welcomed</li><li>
Quality and data driven</li></ul>
Learn more about SBHG at: https://www.starsinc.com/stars-inc/
For Additional Information:
Norcalrecruitment@starsinc.com
In accordance with California law, the grade for this position is 23.74 - 37.98. Placement within the grade is determined based on experience, internal equity, and other factors permitted by law.</div>

Clinical Data & Housing Coordinator

The START Center for Cancer Research

<div>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 access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START&rsquo;s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population &ndash; leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many &ndash; by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. 
 
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. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda &ndash; the most effective cancer drug in medical history. 
 
We are hiring a motivated Clinical Data Entry Coordinator for our Grand Rapids, MI location, who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies.
Essential Responsibilities<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>
Education &amp; Experience<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>
Preferred Education and Experience<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>
Best-in-Class Benefits and Perks 
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:<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> 
More about The START Center for Cancer Research 
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. 
 
Ready to be part of a team changing the future of cancer treatment? 
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. 
 
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.</div>

Clinical Data Entry Coordinator

<div>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. 
 
We are hiring a motivated Clinical Data Entry Coordinator who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies.
This position is offered at a pay range of $24.00 to $27.00 per hour, based on experience, qualifications, and internal equity. In addition, employees in this role may be eligible for an annual bonus of up to 10% of base earnings.
Work Schedule: 8:00 am-5:00 pm EST, Monday-Friday
Location: 405 Lakeville Road, Entrance A, Lake Success, NY 11042
Essential Responsibilities<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>
Education &amp; Experience<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>
Preferred Education and Experience<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>
Best-in-Class Benefits and Perks 
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:<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> 
More about The START Center for Cancer Research 
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. 
 
Ready to be part of a team changing the future of cancer treatment? 
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. 
 
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.</div>

<div>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.
The START Center for Cancer Research is seeking a Clinical Data Entry Coordinator who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies.
Essential Responsibilities<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>Required Education and Experience:<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>
Preferred Education and Experience:<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>Physical &amp; Travel Requirements:<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>
Best-in-Class Benefits and Perks
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:<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>
More about The START Center for Cancer Research
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.
Ready to be part of a team changing the future of cancer treatment?
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.
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.</div>

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>
About Winship Cancer Institute of Emory University</div><div></div><div> 
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> 
Winship is seeking qualified candidates for the Clinical Research Data Coordinator II position. Position details are as follows:</div><div></div><div> 
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> 
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>
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Clinical Research Data Coordinator II- Winship Cancer Institute

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Clinical Research Data Coordinator II- Winship Cancer Institute