clinical trials 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>
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>
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> 
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

Kaiser Permanente

<div><div>Job Summary:</div>
 
Collects data for clinical trials research, independently. Prepares and/or supports the submission of study documentation to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of standard and non-standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions, with limited guidance. Learns about providing input on implementing budgeting components for internally funded standard and non-standard projects. Drafts and/or prepares and submits clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.<div> 

Essential Responsibilities:</div> 
 
<ul><li>Pursues effective relationships with others by proactively providing resources, information, advice, and expertise with coworkers and members. Listens to, seeks, and addresses performance feedback; provides mentoring to team members. Pursues self-development; creates plans and takes action to capitalize on strengths and develop weaknesses; influences others through technical explanations and examples. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; helps others adapt to new tasks and processes. Supports and responds to the needs of others to support a business outcome.</li> 
<li>
Completes work assignments autonomously by applying up-to-date expertise in subject area to generate creative solutions; ensures all procedures and policies are followed; leverages an understanding of data and resources to support projects or initiatives. Collaborates cross-functionally to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports, identifies, and monitors priorities, deadlines, and expectations. Identifies, speaks up, and implements ways to address improvement opportunities for team.</li> 
<li>
Works on budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard and nonstandard projects.</li> 
<li>
Conducts clinical research by: independently collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments); leveraging a comprehensive foundational knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging a comprehensive foundational knowledge of clinical trials, studies, and interventions at the site-level; independently contributing to the development of standard and nonstandard clinical research protocols and other processes of clinical trials; preparing and/or supporting the submission of study documentation to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing standard and non-standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard and non-standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).</li> 
<li>
Ensures research compliance by: independently drafting and/or preparing and submitting clinical trial applications in compliance and consistency with all applicable federal, state, and local regulations, and reviewing and providing input on KP compliance policies and procedures; identifying compliance and/or quality issues and assisting in the development of corrective action plans, escalating as necessary; identifying opportunities to update compliance-monitoring/audit systems and documentation; utilizing standard approaches to analyze risk-management data and making recommendations to mitigate potential risk; independently implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging comprehensive research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.</li> 
<li>
Maintains internal and external effective working relationships by: leveraging a comprehensive foundational knowledge of how to partner with research stakeholders and investigators within and across units to contribute to research projects; independently communicating with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions with limited guidance.</li> 
<li>
Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) in a timely and accurate manner; assisting with the development and/or implementation of standard and nonstandard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a comprehensive foundational knowledge of how to monitor and audit Clinical Trials as well as documenting findings.</li></ul><div> 
Knowledge, Skills and Abilities: (Core)</div><ul><li>
Ambiguity/Uncertainty Management</li><li>
Attention to Detail</li><li>
Business Knowledge</li><li>
Communication</li><li>
Critical Thinking</li><li>
Cross-Group Collaboration</li><li>
Decision Making</li><li>
Dependability</li><li>
Diversity, Equity, and Inclusion Support</li><li>
Drives Results</li><li>
Facilitation Skills</li><li>
Health Care Industry</li><li>
Influencing Others</li><li>
Integrity</li><li>
Learning Agility</li><li>
Organizational Savvy</li><li>
Problem Solving</li><li>
Short- and Long-term Learning &amp; Recall</li><li>
Teamwork</li><li>
Topic-Specific Communication</li></ul><div> 
Knowledge, Skills and Abilities: (Functional)</div><ul><li>
Accountability</li><li>
Adaptability</li><li>
Autonomy</li><li>
Business Relationship Management</li><li>
Clinical Research</li><li>
Clinical Research Quality</li><li>
Compliance</li><li>
Computer Literacy</li><li>
Data Quality</li><li>
Experimental Design</li><li>
Innovative Mindset</li><li>
Laboratory Equipment</li><li>
Laboratory Procedures</li><li>
Managing Diverse Relationships</li><li>
Organizational Skills</li><li>
Project Management</li><li>
Project Management Tools</li><li>
Quality Assurance Process</li><li>
Quantitative Research Methods</li><li>
Research Ethics</li><li>
Stakeholder Management</li><li>
Survey Methodology</li><li>
The Scientific Method</li></ul><div> 
Minimum Qualifications:</div> 
 
<ul><li>Bachelors degree in Science, Public Health, Health Care Administration, or related field AND minimum two (2) years of experience in clinical research or a directly related field OR Minimum five (5) years of experience in clinical research or a directly related field.</li></ul><div> 
Preferred Qualifications:</div><ul><li>
Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).</li><li>
Basic Life Support (BLS) Certification.</li></ul> 
PrimaryLocation : Oregon,Portland,Center for Health Research 
HoursPerWeek : 40 
Shift : Day 
Workdays : Mon, Tue, Wed, Thu 
WorkingHoursStart : 07:00 AM 
WorkingHoursEnd : 05:30 PM 
Job Schedule : Full-time 
Job Type : Standard 
Employee Status : Regular 
Employee Group/Union Affiliation : NUE-NW-01|NUE|Non Union Employee 
Job Level : Individual Contributor 
Job Category : Research 
Department : Center for Health Research - RI Leadership - 1001 
Travel : No 
Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status.</div>

Clinical Research Coordinator III, Clinical Trials

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

Medix™

<div>
 
 The Clinical Research Coordinator (CRC) is responsible for the daily management and execution of clinical trials at the research site, working under the guidance of the Principal Investigator (PI). The CRC ensures that studies are conducted in accordance with the study protocol, ICH-GCP guidelines, FDA regulations, and institutional SOPs. The CRC acts as a liaison between the PI, study participants, sponsors, and the Institutional Review Board (IRB) to ensure participant safety and data integrity.
 
 
 Key Responsibilities
 
 <ul>
 <li>
 
 Study Startup &amp; Regulatory:
 
 Assist with protocol review, IRB submissions, and preparation of regulatory binders.
 </li>
 <li>
 
 Participant Recruitment &amp; Screening:
 
 Identify, recruit, and screen potential participants against inclusion/exclusion criteria.
 </li>
 <li>
 
 Informed Consent:
 
 Conduct the informed consent process, ensuring participants understand study requirements, risks, and benefits.
 </li>
 <li>
 
 Study Visits &amp; Procedures:
 
 Coordinate and conduct study visits, perform study procedures (e.g., ECGs, vitals), and manage participant follow-up.
 </li>
 <li>
 
 Data Management:
 
 Collect, record, and enter accurate source data into Electronic Data Capture (EDC) systems in a timely manner; resolve queries.
 </li>
 <li>
 
 Specimen Management:
 
 Collect, process, label, store, and ship laboratory specimens according to the protocol and IATA regulations.
 </li>
 <li>
 
 Safety &amp; Compliance:
 
 Monitor participant safety, record adverse events (AEs), and report serious adverse events (SAEs) promptly to the PI and sponsor.
 </li>
 <li>
 
 Investigational Product (IP):
 
 Oversee proper receipt, storage, dispensing, and accountability of study drugs/devices.
 </li>
 <li>
 
 Site Visits:
 
 Host sponsor monitoring visits
 </li>
 </ul>
 
 
</div>

Clinical Research Coordinator  252171

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

Fortrea

<div>Join one of the world&rsquo;s largest Clinical Research Organizations and support early-phase clinical trials in a fast‑paced, highly collaborative environment. As a Clinical Research Coordinator, you will oversee the operational execution of assigned studies, ensuring compliance with protocols, regulations, and SOPs while maintaining participant safety and data integrity.
In this role, you&rsquo;ll work closely with Project Managers, Principal Investigators, and site teams, serving as the primary site contact for study updates, issue escalation, and client requirements. You may also mentor junior staff and support moderately complex studies.
What You&rsquo;ll Do<ul><li>
Lead study start-up activities, including developing study-specific documents, schedules, and procedures.</li><li>
Coordinate key study events (check‑ins, PK days, check‑outs), ensuring participant safety, comfort, and protocol adherence.</li><li>
Attend and contribute to study meetings (e.g., Start-Up, Planning, Site Initiation).</li><li>
Review study protocols and provide site feedback on feasibility, logistics, and safety considerations.</li><li>
Partner with Operations, Pharmacy, and lab teams to ensure readiness, proper resourcing, and smooth dosing processes.</li><li>
Support client interactions, including visits, calls, and audits.</li><li>
Maintain accurate study documentation and oversee contributions to the eTMF.</li><li>
Identify and document protocol deviations and support quality improvement efforts.</li><li>
Complete other duties as assigned.</li></ul>
What You Bring<ul><li>
Bachelor&rsquo;s degree in life sciences, pharmacy, or related field preferred; clinical/technical certifications accepted.</li><li>
3+ years of experience in a clinical research or related environment (experience may substitute for education).</li><li>
Knowledge of study protocols, ICH/GCP guidelines, and the drug development process.</li><li>
Strong coordination, communication, and problem‑solving skills.</li><li>
Customer service or team coordination experience preferred.</li></ul>
Work Environment:<ul><li>
Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.</li><li>
Occasional drives to site locations, occasional domestic travel.</li><li>
Exposure to biological fluids.</li><li>
Personal protective equipment required such as protective eyewear, garments, and gloves.</li></ul>
Physical Requirements:<ul><li>
Ability to work in an upright and /or stationary position for 6-8 hours per day.</li><li>
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.</li><li>
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</li><li>
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</li><li>
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</li><li>
Regular and consistent attendance.</li><li>
Varied hours may be required.</li></ul>
The important thing for us is you are comfortable working in an environment that is:<ul><li>
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.</li><li>
Changing priorities constantly asking you to prioritize and adapt on the spot.</li><li>
Teamwork and people skills are essential for the study to run smoothly.</li><li>
Technology based. We collect our data directly into an electronic environment.</li></ul>
What do you get?<ul><li>
Regular, full-time, or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:</li><li>
Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)</li><li>
401(K)</li><li>
Paid time off (PTO)</li><li>
Employee recognition awards</li><li>
Multiple ERG&rsquo;s (employee resource groups)</li><li>
Experience coordinating people or processes; customer‑service experience helpful.</li></ul>
Learn more about our EEO &amp; Accommodations request here.</div>

Clinical Research Coordinator I, Early Phase Clinical Research - Dallas, TX

Nuvance Health

<div>Description 
 
At Nuvance Health, we enjoy the benefits of a two-state system as we cultivate an inclusive culture where everyone feels welcomed, respected and supported. Together, we are a team of 15,000+ strong hearts and open minds. If you share our values of connected, personal, agile and imaginative, we invite you to discover what&rsquo;s possible for you and your career. 
 
Danbury Hospital, a 456-bed acute care hospital, has been providing award-winning, personalized patient care to the people of Western Connecticut for 140 years. Our specialty areas of excellence include a Level III NICU, a certified Thrombectomy-Capable Stroke Center, and compassionate psychiatric care, including a partial-hospitalization program.
 
 
Our accolades include the following: 
 
 The Leapfrog Group - Grade A for quality and patient safety<ul><li>
U.S. News &amp; World Report - High performance in heart failure treatment</li><li>
Healthgrades - One of America&rsquo;s 50 Best Hospitals</li><li>
Surgical Review Corporation (SRC) - Robotic Center of Excellence</li><li>
Joint Commission - Gold seal of approval in spine surgery</li></ul> 
At Danbury Hospital, we take great pride in our team members and their passion for providing the best care possible&mdash;always with heart. For many of our team members, that care extends beyond the walls of our hospital. We volunteer at local non-profits and participate in community initiatives and events. Our dedication to the health and well-being of our entire community makes this a truly special place to work. 
 
Title: Clinical Research Coordinator - Danbury Hospital Clinical Trials - Full time/40 hours per week, 8- hours shifts, 8:00am - 4:30pm, Monday - Friday.
Summary: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies. Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB). Coordinates studies in varied therapeutic areas including but not limited to Cardiovascular, Pulmonary, Gastroenterology, Neurology, Endocrinology, Dermatology and Rheumatology. Functions independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations.
Responsibilities:
1. Screens patients for study participation e.g. reviews medical record, collaborates with medical &amp; research staff, etc. and procures informed consent.
2. Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Resolves all patient queries.
3. Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g. consulting physicians), sponsors, federal regulatory agencies, and other involved parties as required.
4. Participates in investigator, coordinator, or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors. 
5. Maintains current regulatory (GCP, HSR) and study specific required trainings.
6. Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).
7. Educates hospital staff about protocols through in-services, written materials and one-on-one interaction, for each study and each patient, and for general marketing.
8. Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).
9. Performs procedures including EKG, Phlebotomy, blood and body fluid sampling, packing and shipment of human samples, body measurements and examinations within scope of practice and training, consistent with clinic and study specific policies/procedures and scope of care under the guidance of the supervisor.
10. Fulfills all compliance responsibilities related to the position.
11. Maintain and Model Nuvance Health Values.
12. Demonstrates regular, reliable and predictable attendance.
13. Performs other duties as required.
Other Information:
Education and Experience Requirements:<ul><li>
Bachelor's degree or Allied Health professional degree and three years job-related experience.</li><li>
Minimum 1-year clinical experience in medical field.</li><li>
Prefer: Clinical Research experience</li></ul>
Minimum Knowledge, Skills and Abilities Requirements:<ul><li>
Fluency in medical terminology.</li><li>
Knowledge of clinical trials, research and general medicine. Strong computer skills.</li><li>
Strong attention to detail and organizational skills</li><li>
Outstanding interpersonal skills</li></ul>
License, Registration, or Certification Requirements:<ul><li>
Basic Life Support current or willing to take course</li><li>
Valid Driver license</li><li>
Prefer: Professional research certification</li></ul>
Salary Range: $29.65 - $55.55 hourly (Pay per years of relative experience) 
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Clinical Research Coordinator - Danbury Hospital Clinical Trials department - Danbury, CT

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