lead clinical research coordinator

UT Southwestern Medical Center

WHY UT SOUTHWESTERN?
 
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
 
JOB SUMMARY
 
Works under the direction of an Investigator(s) with limited supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of research data in support of multiple and/or complex research studies.
 
BENEFITS
 
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
 
PPO medical plan, available day one at no cost for full-time employee-only coverage
 
100% coverage for preventive healthcare-no copay
 
Paid Time Off, available day one
 
Retirement Programs through the Teacher Retirement System of Texas (TRS)
 
Paid Parental Leave Benefit
 
Wellness programs
 
Tuition Reimbursement
 
Public Service Loan Forgiveness (PSLF) Qualified Employer
 
Learn more about these and other UTSW employee benefits!
 
EXPERIENCE AND EDUCATION
 
Required
 Education
 Bachelor's Degree in medical or science related field
 
Experience
 4 years of clinical research experience with Bachelor's Degree
 
Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
 
May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
 Preferred
 Licenses and Certifications
 (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
 
(CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.
 
ACRP of SOCRA certification a plus.
 
JOB DUTIES
 Maintains required subject documentation for each study protocol.
 
Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
 
Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
 
Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
 
Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
 
Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.
 
Assists in developing and implementing research studies, may include writing clinical research protocols.
 
Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
 
May provide supervision to other members of the research team as necessary.
 
May perform research billing activities, as needed, based on size of department (including linking patient calendars
 
Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
 
Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
 
Coordinates data management and collection for national (larger/more complex) research studies.
 
Serves as lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
 
Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
 
Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
 
Provides in-service training to all study team members and communicates to involved groups.
 
Reviews research study protocols to ensure feasibility requirements of the study.
 
Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
 
Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
 
Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
 
Performs other duties as assigned.
 
SECURITY AND EEO STATEMENT
 
Security
 This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
 
EEO
 
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

Lead Clinical Research Coordinator, Simmons Cancer Center

Rheumatology Office Alex DeJesus, MD

Clinical Research Coordinator <ul><li>Location Houston, Tx</li></ul>1 years of Experience requiredJob Description Clinical Research Coordinator (CRCs) Clinical Research Coordinator will work in a team environment under the Leadership of the investigator with supervision of the Research Director or Team Lead.Job Purpose: To promote good clinical practice in the conduct of clinical investigations. The Coordinator must possess an in depth knowledge of federal regulations to conduct clinical trials and protect human subject. One must be able to assure compliance with protocol and regulatory requirements, by collecting, recording and maintaining data and source documentation.Participates in Subject Recruitment, Enrollment and Follow up Procedures By: <ul><li>Integrating proposed clinical trial with current research activities</li><li>Attending and participating in investigator meetings</li><li>Listing and clarifying questions and concerns with the sponsor and investigator regarding enrollment goals sponsor expectations and study procedures</li><li>Monitoring enrollment goals and modifying recruitment plan as necessary</li><li>Maintaining patient screening/enrollment logs</li><li>Reviewing inclusion/exclusion criteria with investigator to assure subject eligibility</li><li>Reviewing and verifying source documents in subject&rsquo;s medical record to confirm subject&rsquo;s eligibility assuring that all screening, eligibility and enrollment procedures are performed</li><li>Reviewing the protocol, informed consent form and follow up procedure with potential study subjects</li><li>Conducting interviews at assess the subject&rsquo;s ability and willingness to follow and complete study procedures and visits</li><li>Obtaining informed consent from research subjects prior to any study related procedures and documenting appropriately</li><li>Following randomization procedures as per protocol</li><li>Dispensing study article as appropriate</li><li>Scheduling subject&rsquo;s follow up visits</li><li>Reviewing diaries and questionnaires completed by subjects</li><li>Ensuring appropriate specimen collection, batching and shipping as required</li><li>Assessing subject compliance with the test article and follow up visits</li></ul>Protects Subjects Confidentiality By:<ul><li>Protecting patient privacy during initial and follow up interviews</li><li>Documenting protocol deviations and exemptions</li><li>Obtaining/reviewing original source documents</li><li>Abstracting data from medical records to clinic, consultation and referral notes to study forms and flow sheets</li><li>Recording accurate and timely data onto case report forms</li><li>Maintaining source documentation for all case report entries as applicable</li><li>Keying data for electronic submission</li><li>Transmitting data via fax, mail or electronically as requested</li><li>Correcting and editing case report form entries as appropriate</li><li>Resolving data queries</li><li>Completing and maintaining the study article dispensing log</li><li>Maintaining files of all study related documentation</li><li>Recognizing and reporting common laboratory values and alerts to investigator and sponsor</li></ul>Participates in Monitoring Visits and Audits By:<ul><li>Scheduling sponsor monitoring visits</li><li>Ensuring that EDC for Sponsor company is done within 3 business days and is correct</li><li>Collecting source documents for sponsor/audit review</li><li>Meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol related issues</li><li>Preparing for and participating in FDA inspections as needed</li></ul>Maintains Professional and Technical KnowledgeBy:<ul><li>Attending educational workshops</li><li>Reviewing professional publications</li></ul>Job Type: Full-timePay: $37,941.00 - $55,091.00 per yearBenefits:<ul><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Experience:<ul><li>Pharmaceutical research: 1 year (Required)</li></ul>Language:<ul><li> Fluent Spanish (Required)</li></ul>Ability to Commute:<ul><li>Houston, TX 77089 (Required)</li></ul>Work Location: In person

Clinical Research Coordinator 1 yr. exp req.

Premiere Health and Wellness

Lead Clinical Research Coordinator Job DescriptionJob Title: Lead Clinical Research CoordinatorReports To: Clinical Research Site ManagerDepartment: Clinical OperationsLocation: On-site (SKYCRNG Network Site)Position SummaryThe Lead Clinical Research Coordinator (Lead CRC) provides operational leadership and oversight of clinical research studies conducted at the site. This role is responsible for ensuring protocol compliance, subject visit execution, investigational product (IP) accountability, regulatory maintenance, and serving as a DEXA technician, while serving as a manager to CRCs. The Lead CRC works closely with the Site Manager to support study start-up, execution, study maintenance, and close-out activities in accordance with ICH-GCP, IRB requirements, sponsor protocols, and SKYCRNG&rsquo;s Standard Operating Procedures (SOPs).Key ResponsibilitiesStudy Operations &amp; Compliance<ul><li>Maintain and oversee subject visit schedules, ensuring protocol-required visits and procedures are completed accurately and on time.</li><li>Ensure subject visit compliance across all CRCs, including source documentation, protocol adherence, and timely data, imaging, and lab query resolution by CRC staff.</li><li>Oversee and maintain investigational product (IP) accountability, ensuring accurate documentation, storage, reconciliation, and compliance.</li><li>Maintain the regulatory binder, ensuring all essential documents are complete, current, and audit-ready.</li><li>Attend and actively participate in Site Initiation Visits (SIVs) and other required sponsor or CRO meetings.</li></ul>Data Quality &amp; Query Management<ul><li>Oversee the resolution of data, lab, and imaging queries, ensuring timely, accurate responses and appropriate follow-up.</li><li>Collaborate with CRCs to identify trends, recurring errors, or training needs related to source quality and visit compliance.</li><li>Provide ongoing subject study status updates to the Site Manager, including enrollment, visit completion, and outstanding issues.</li></ul>Study Start-Up &amp; Close-Out &amp; Systems Readiness<ul><li>Work closely with the Site Manager to collect, organize, and submit study start-up documents, including regulatory and training materials.</li><li>Create and maintain study-specific checklists to support efficient study execution and consistent CRC workflows.</li><li>Complete continuing review and study termination IRB submissions in accordance with IRB requirements and established timelines.</li></ul>Leadership, Mentorship &amp; Team Development<ul><li>Serve as a manager and subject-matter resource for CRCs, providing guidance on protocol requirements, documentation standards, and best practices.</li><li>Support training, onboarding, and professional development of CRC staff.</li><li>Ensure all site staff have appropriate access to study systems, including EDC, IRT/IXRS, ePRO, imaging platforms, and sponsor portals.</li><li>Monitor and support staff training completion, system access readiness, and protocol-required certifications.</li><li>Promote a culture of compliance, accountability, collaboration, and continuous improvement across the site and SKYCRNG network.</li></ul>&middot;DEXA &amp; Specialized Procedure Oversight<ul><li>Perform and/or coordinate DEXA scans, including the completion, tracking, and documentation of all outside DEXA scans, as required per protocol.</li></ul>QualificationsRequired<ul><li>Minimum 3&ndash;5 years of clinical research coordination experience.</li><li>Strong working knowledge of ICH-GCP, IRB requirements, and FDA regulations.</li><li>Proven experience with regulatory binders, IP accountability, and subject visit management.</li><li>Experience working with EDC systems, IRB portals, and sponsor systems.</li><li>Excellent organizational, communication, and leadership skills.</li></ul>Preferred<ul><li>Prior experience in a Lead CRC or Senior CRC role.</li><li>Experience with DEXA scans and imaging-based clinical studies.</li><li>Multi-protocol and multi-therapeutic area experience.</li><li>Professional certification (CCRC, CCRP, or equivalent).</li></ul>Core Competencies<ul><li>Attention to detail and regulatory compliance</li><li>Leadership and team mentorship</li><li>Time management and prioritization</li><li>Data quality oversight and query resolution</li><li>Cross-functional collaboration</li><li>Audit and inspection readiness</li></ul>Work Environment<ul><li>Clinical research site environment</li><li>May require extended hours based on study needs and sponsor visits</li><li>Occasional travel for meetings, monitoring visits, or training, if applicable</li></ul>SKYCRNG is committed to excellence, integrity, and community-focused research. This role is critical to maintaining our reputation as an audit-ready, enrollment-ready, high-performing clinical research network.Job Type: Full-timeWork Location: In person

Clinical Research Coordinator

AMR Clinical

<div>The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. 
To consistently embody AMR Clinical&rsquo;s Core Values:<ul><li>
United We Achieve</li><li>
Celebrate Diverse Perspectives</li><li>
Do the Right Thing</li><li>
Adapt and Persevere</li></ul>
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:<ul><li>
Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.</li><li>
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.</li><li>
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.</li><li>
Establish understanding of SOP&rsquo;s and implement the SOP&rsquo;s</li><li>
Gain understanding of the pharmaceutical drug per clinical trial.</li><li>
Develop detailed knowledge of protocol and procedures per clinical research study.</li><li>
Communicate effectively with study sponsors, CROs, monitors/CRA&rsquo;s, IRBs, laboratories, and clinical personnel within the research industry.</li><li>
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.</li><li>
Establish and maintain patient rapport.</li><li>
Clinical data collection (vital signs, EKG recording, weight, height, etc.)</li><li>
Obtain medical records and review as required.</li><li>
Phlebotomy</li><li>
Specimen collection, processing, and storage</li><li>
Transporting clinical specimens to the laboratory.</li><li>
Educate subjects on diaries and oversees compliance with diary completion.</li><li>
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)</li><li>
Responsible for completing patient phone call visits in accordance to the standard protocol period.</li><li>
Ensure documentation follows ALCOA standards and is completed in a timely manner.</li><li>
Ensure all necessary documents are completed, signed and dated.</li></ul><ul><li>
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.</li><li>
Manage study inventory and order supplies as needed.</li><li>
Prepare and assist study monitors during onsite visits.</li></ul><ul><li>
 Maintain familiarity with all ongoing clinical research studies.</li><li>
Travel to Investigator meetings as needed.</li><li>
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul> 
Desired Skills and Qualifications:<ul><li>
Licensed RN or LPN</li><li>
1 year of experience in clinical research.</li><li>
Completion of formal medical training, educational program, or healthcare experience</li><li>
Strong medical terminology</li><li>
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).</li><li>
Ability to work independently and lead study-related tasks.</li><li>
Ability to multi-task in a high-paced evolving environment.</li><li>
Exceptional listening, written, and verbal communication skills as well.</li><li>
Demonstrate proficiency in office equipment and software programs.</li><li>
Excellent organizational and task management skills.</li><li>
Ability to be ambulatory most of the workday.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li><li>
Fluent in English.</li></ul> 
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.</div>

Clinical Research Coordinator/ LPN-RN

INSIGHT

<div></div><div><div>Job Title: Clinical Research Coordinator III &ndash; Team Lead 
Department: Clinical Research Operations 
Location: On-site (Insight Hospital &amp; Medical Center Chicago) 
Schedule: Full-time, Monday through Friday (8AM-5PM) &ndash;additional flexibility required to meet job requirements</div>
<div>Reports To: Director of Clinical Trials</div>
<div>Position Summary</div>
<div>The Clinical Research Coordinator III &ndash; Team Lead is a senior-level hybrid role responsible for leading the coordination of complex clinical trials while supervising and mentoring the on-site research team. This position functions as a &ldquo;player/coach,&rdquo; combining direct study coordination with oversight of Clinical Research Coordinators and Clinical Research Assistants. The CRC III &ndash; Team Lead ensures operational excellence, regulatory compliance, and a culture of accountability and continuous improvement.</div>
<div>This role also collaborates closely with the Patient Recruitment department to support enrollment success through candidate prescreening, outreach, and community engagement. In addition, the CRC III &ndash; Team Lead supports regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources.</div>
<div>Core Competencies</div>
<ul><li>Advanced knowledge of clinical trial operations, GCP, FDA regulations, and IRB processes</li>
<li>Strong leadership and coaching skills with a collaborative, solutions-oriented mindset</li>
<li>Excellent communication and interpersonal abilities across diverse stakeholders</li>
<li>High attention to detail, time management, and multitasking capabilities</li>
<li>Commitment to quality, compliance, and participant safety</li></ul> 
<div></div><div>Key Responsibilities</div>
<div>Study Leadership and Coordination</div>
<ul><li>Serve as lead coordinator on high-priority or complex trials, managing all phases from startup to closeout</li>
<li>Provide backup coverage and operational support for other coordinators during absences or escalations</li>
<li>Ensure protocol adherence, timely data entry, and accurate documentation across assigned studies</li>
</ul><div>Team Supervision and Mentorship</div>
<ul><li>Supervise and mentor Clinical Research Coordinators I and II and Clinical Research Assistants</li>
<li>Lead onboarding, training, and ongoing development for study staff</li>
<li>Conduct regular team huddles, protocol reviews, and best practice sessions</li>
</ul><div>Regulatory and Quality Support</div>
<ul><li>Support regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources</li>
<li>Ensure accurate completion, review, and submission of IRB documents, amendments, and safety reports</li>
<li>Maintain essential regulatory files and sponsor communications</li>
<li>Participate in internal audits, monitoring visits, and CAPA implementation</li>
</ul><div>Patient Recruitment and Engagement</div>
<ul><li>Partner with the Patient Recruitment department to develop and execute enrollment strategies</li>
<li>Conduct candidate prescreening and outreach activities to support recruitment goals</li>
<li>Participate in community engagement efforts to raise awareness and build trust with potential participants</li>
</ul><div>Operational Collaboration</div>
<ul><li>Serve as liaison between the research team, investigators, sponsors, and institutional departments</li>
<li>Assist in resource planning, visit scheduling, and workload balancing</li>
<li>Contribute to SOP development, workflow optimization, and quality improvement initiatives</li>
</ul>
<div>Qualifications and Requirements</div>
<ul><li>Education: Bachelor&rsquo;s degree in life sciences, nursing, or a related field</li>
<li>preferred</li>
<li>Experience: Minimum 4 to 6 years of clinical research coordination experience, including leadership or mentorship responsibilities</li>
<li>Certification: Clinical research certification (e.g., ACRP, SOCRA) preferred</li>
<li>Technical Skills: Proficiency in CTMS, E-Source, E-Reg, EDC platforms, and regulatory systems; strong computer literacy (Microsoft Office Suite, electronic communication tools)</li>
<li>Knowledge Base: Advanced understanding of clinical trial operations, GCP, FDA regulations, and IRB processes</li>
<li>Communication: Excellent written and verbal communication skills; ability to interact effectively with investigators, sponsors, staff, and participants</li>
<li>Leadership: Demonstrated ability to supervise, mentor, and develop staff while fostering accountability and collaboration</li>
<li>Organizational Skills: High attention to detail, time management, and multitasking capabilities; ability to prioritize competing demands</li>
<li>Flexibility: Willingness to adjust schedule to accommodate study visits, meetings, and events that may occur earlier, later, or on weekends</li>
<li>Travel: Ability to travel to training meetings, conferences, satellite sites and other Insight Health System locations as required</li>
<li>Professional Standards: Commitment to quality, compliance, participant safety, and continuous improvement</li></ul></div>

Clinical Research Coordinator III - Team Lead

University of Florida

<div><div>JOB NO:
<div>539487</div> 
WORK TYPE:
<div>Staff Part-Time</div> 
LOCATION:
<div>Main Campus (Gainesville, FL)</div> 
CATEGORIES:
<div>Health Care Administration/Support</div> 
DEPARTMENT:<div>
29180800 - MD-NEUROMUSCULAR NEUROLOGY</div></div> 
<div>
<div><div><div><div>CLASSIFICATION TITLE:</div>
<div>
Clinical Research Coord I</div> 
</div> 
<div><div>CLASSIFICATION MINIMUM REQUIREMENTS:</div>
<div>
Associate&rsquo;s degree or an allied health professional degree in an appropriate area and one year of relevant
 
experience; or an equivalent combination of education and experience.</div> 
</div> 
<div><div>JOB DESCRIPTION:</div>
<div>
The Department of Neurology, Neuromuscular Division at the University of Florida is seeking a candidate who has experience with clinical trials specifically FDA compliance, institutional review board, and NIH funded trials for a Clinical Research Coordinator I position. The Clinical Research Coordinator I is responsible for coordinating and conducting neuromuscular research studies and managing all regulatory aspects of those
 
neuromuscular clinical trials within the Department of Neurology. The Coordinator I will also assist lead coordinators and investigators in clinical trial and database related procedures. The spectrum of the work involves coordination of the participant visits, obtaining consent, recording data, and management of IRB related requirements.

About this Role

Research Administration &amp; Compliance
<ul>
<li>Oversee administrative and regulatory aspects of assigned research studies</li>
<li>Identify, document, and report adverse events, protocol deviations, and non-compliance to the appropriate IRB</li>
<li>Interpret and apply FDA and IRB regulations to ensure study compliance</li>
<li>Support investigators in meeting regulatory requirements and maintaining audit readiness</li>
<li>Maintain accurate regulatory documentation and filing systems for active protocols</li>
<li>Study Coordination &amp; Communication</li>
<li>Communicate regularly with principal investigators, lead coordinators, and research staff regarding recruitment, required trainings, and protocol amendments</li>
<li>Coordinate with study monitors and sponsors for scheduled monitoring visits and data management activities</li>
<li>Respond to data queries, monitor for data delinquencies, and address sponsor or study-related requests</li>
<li>Escalate concerns related to protocol deviations and adverse events to the Principal Investigator and lead coordinators</li>
</ul>
Data &amp; Clinical Trial Tracking
<ul>
<li>Update clinical trial management systems and internal tracking logs</li>
<li>Track participant visits, enrollment activity, and billable services</li>
</ul>
Program Representation &amp; Sample Management
<ul>
<li>Represent the neuromuscular program at research meetings and conferences (approximately 10%)</li>
<li>Coordinate collection, processing, and shipment of biological samples for assigned trials</li>
<li>Ensure adherence to safety and quality standards for handling, processing, shipping, and disposal of biological specimens</li></ul> 


About the Department of Neurology, Neuromuscular Division at the University of Florida

The Department of Neurology, Neuromuscular Division at the University of Florida is a nationally recognized leader in the diagnosis, treatment, and research of neuromuscular disorders. Led by Dr. James Wymer, the division specializes in conditions such as ALS, myasthenia gravis, muscular dystrophy, and peripheral neuropathies. It offers patients access to cutting-edge clinical trials and emerging therapies through its robust research program. The team takes a multidisciplinary approach, working closely with physical therapists, occupational therapists, and other specialists to provide comprehensive, patient-centered care. Faculty are actively involved in education and training, helping to shape the next generation of neurologists and clinical research professionals. The division also collaborates with national organizations and industry partners to advance the development of new treatments and improve patient outcomes.

To learn more about the Neuromuscular Division at the University of Florida, please visit https://neurology.ufl.edu/divisions/neuromuscular/ 


We Offer Exceptional Benefits
<ul>
<li>Low-cost State Health Plans: Medical, Dental, and Vision Insurance</li>
<li>Life and Disability Insurance</li>
<li>Generous Retirement Options to secure your future</li>
<li>Comprehensive Paid Time Off Packages: (includes over 10 paid holidays, as well as paid family, sick and vacation leave) 
Exceptional Personal and Professional Development Opportunities: Access to UF Training &amp; Organizational Development programs, leadership development, LinkedIn Learning, and more</li>
<li>Tuition Assistance through the UF Employee Education Program</li>
<li>Public Service Loan Forgiveness (PSLF) Eligible Employer</li></ul> 


About Gainesville, Florida

Home to the University of Florida, one of the nation's top public universities, Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living, no state income tax, and mild winters. Enjoy the outdoors with over 30 miles of bike trails, freshwater springs, and numerous water activities, plus easy access to beaches and world-class theme parks.

Gainesville combines historic charm with modern amenities, including a great school system, a lively downtown, and a thriving local culture with farmers' markets and craft breweries. Discover professional growth and quality of life in Gainesville&mdash;where community, innovation, and work-life balance meet!

For more information, check out: The Guide to Greater Gainesville and Explore Gainesville in 60 seconds</div> 
</div> 
<div><div>EXPECTED SALARY:</div>
<div>
$43,000 - $46,000 annually</div> 
</div> 
<div><div>MINIMUM QUALIFICATIONS:</div>
<div>
Associate&rsquo;s degree or an allied health professional degree in an appropriate area and one year of relevant
 
experience; or an equivalent combination of education and experience.</div> 
</div> 
<div><div>PREFERRED QUALIFICATIONS:</div>
<div>
The ideal candidate must possess:
<ul>
<li>Bachelor's degree in an appropriate area and relevant experience in clinical area; or an equivalent
 
combination of education and experience.</li>
<li>Experience with Microsoft Office</li>
<li>Strong interpersonal skills, as well as the ability to work with vulnerable patient populations</li>
<li>Highly resourceful team player who takes initiative</li>
<li>Proven ability to handle confidential information with discretion</li>
<li>Detail oriented with a passion for research</li>
<li>Demonstrate ability to achieve high performance goals and meet deadlines in a fast-paced environment.</li>
<li>Experience with clinical trials specifically FDA compliance, institutional review board, NIH funded trials.</li>
</ul>
</div></div> 
<div><div>SPECIAL INSTRUCTIONS TO APPLICANTS:</div>
<div>
To be considered, please upload the following:
<ul>
<li>Cover Letter</li>
<li>Resume</li>
<li>Contact information for three professional references</li>
</ul>
This is a time-limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.</div> 
</div> 
<div><div>HEALTH ASSESSMENT REQUIRED:</div> <div>Yes</div></div></div> 
</div>
</div><div>ADVERTISED:
<div>10 Apr 2026</div> Eastern Daylight Time 
APPLICATIONS CLOSE:
<div><div>24 Apr 2026</div></div>
Eastern Daylight Time</div></div>

Clinical Research Coordinator I - Neurology - Neuromuscular Division

University of Miami

<div>Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet .
Clinical Research Coordinator 2
The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth Medical Campus. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.
 
 
CORE JOB FUNCTIONS
<ul><li>Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
</li><li>Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
</li><li>Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
</li><li>Maintains study binders and filings according to protocol requirements, UM and department policy.
</li><li>Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
</li><li>Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
</li><li>Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
</li><li>Assists with study orientation and protocol related in-services to research team and clinical staff.
</li><li>Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
</li><li>Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators&rsquo; academic administrative personnel, and departments.
</li><li>Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
</li><li>Adheres to cultural competency guidelines; implements strategies to meet study participants&rsquo; needs for language translation, health literacy, etc.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets.
</li></ul>Department Specific Functions 
The Clinical Research Coordinator 2 is a mid-level professional working within the Neurology Stroke Division. This role involves assisting in the planning, coordination, implementation, monitoring, and evaluation of specific clinical research studies. The coordinator supports daily operations related to the execution of clinical research protocols, from initiation to close-out, ensuring compliance with regulatory and sponsor guidelines. Responsibilities include collaborating with study team members, faculty, and other staff or study sites to maintain participant safety and adherence to approved protocols.
Duties covered in this position encompass all aspects of clinical trial coordination, emphasizing regulatory compliance and participant safety. In addition, the Clinical Research Coordinator-2 must work closely with and maintain constant communication with the Study Principal Investigator and Senior Study Coordinators to ensure alignment and seamless execution of research activities.
The coordinator also manages administrative tasks, facilitates information flow, and organizes study activities and personnel.
Duties covered in this position encompass all aspects of clinical trial coordination, emphasizing regulatory compliance and participant safety. 
The Clinical Research Coordinator 2 is responsible for coordinating clinical research trials within the Neurology Stroke Division, including the following functions:
<ul><li>Complete and maintain the institution-required training essential to gain certification in research ethics, compliance, and regulatory standards to conduct human subject studies.
</li><li>Completion of all study-specific trainings and certifications.
</li><li>Screening participants for eligibility.
</li><li>Conducting the informed consent process.
</li><li>Enrolling participants and, as required, performing randomization according to the study protocol.
</li><li>Coordinate the follow up study visits following the protocol.
</li><li>Ensuring regulatory compliance throughout the study. Maintain study files according to protocol requirements, UM guidelines, and department policy.
</li><li>Entering study data into the electronic database in a timely manner.
</li><li>Assisting with investigational medication dispensing from the Research Pharmacy/Investigational Pharmacy.
</li><li>Communicate with the Research Pharmacy/Investigational Pharmacy to ensure the study medication is kept following the study specifications and maintain accurate study drug accountability.
</li><li>Monitors compliance with processing, storing and shipping participant specimens to central research laboratory as per the study protocol.
</li><li>Meeting with study monitors and maintaining all regulatory documents. Flexible hours may be necessary depending on clinic days.
</li><li>The CRC-2 may also collaborate with investigators in other divisions on sponsored research studies.
</li><li>Support multiple stroke research studies by performing various duties.
</li><li>Assist with the startup of new studies.
</li><li>Assist in onboarding and training new study team members.
</li><li>Provide guidance and oversight to junior research coordinators.
</li><li>Perform quality assurance (QA) on study binders in preparation for study monitor visits.
</li><li>Communicate with Research Pharmacy/Investigational Pharmacy to ensure proper management and accountability of study medication
</li><li>Demonstrate the ability to work independently or collaboratively within a team environment.
</li><li>Ability to work independently and/or in a collaborative environment.
</li><li>Ability to work in a fast-paced environment due to the limited time window for enrollment in acute Stroke clinical trials.
</li><li>Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
</li><li>Prepares local and Central IRB submissions including initial submission, continuing reviews, reportable events, and amendments. 
</li></ul> 
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
 
 
CORE QUALIFICATIONS
<ul><li>Bachelor&rsquo;s degree in relevant field required
</li><li>Minimum 2 years of relevant experience required 
</li></ul> 
Knowledge, Skills and Abilities:
<ul><li>Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
</li><li>Teamwork: Ability to work collaboratively with others and contribute to a team environment.
</li><li>Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
</li><li>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
</li></ul>The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Full time
Employee Type:
Staff</div>

Clinical Research Coordinator 2

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