clinical research coordinator 1 Jobs in Miami

clinical research coordinator 1

clinical research coordinator 2 Jobs in Miami

clinical research coordinator 2

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clinical research associate sponsor dedicated

ICON plc

<div>Clinical Research Associate, Sponsor Dedicated
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a CRA II at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. This position is sponsor dedicated looking for someone to monitor non-oncology studies: Metabolic, Inflammation, Cariovascular in Miami or South Florida.
What You Will Do:
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. 
 
Key responsibilities include:<ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul>
Your Profile:
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:<ul><li>
Various annual leave entitlements</li><li>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</li><li>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</li><li>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know<div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div>

Clinical Research Associate, Sponsor Dedicated

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 .
The Miami Transplant Institute is currently seeking a Full-Time Clinical Research Coordinator 2 to work onsite in Miami. 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 RESPONSIBILITIES:
<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.
 
 
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.
</li></ul>CORE QUALIFICATIONS
<h2 class="jobSectionHeader">Education :
</h2><ul><li>Bachelor's degree required.
</li></ul>Experience:
<ul><li>Three years of relevant work experience in clinical trials management or research experience in clinical trial setting.
</li></ul>Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li><li>Ability to work independently and/or in a collaborative environment. 
 
</li></ul>Department Specific Functions:
<ul><li>Ability to work evenings, nights, and weekends.
</li><li>Coordinates the implementation of multiple complex clinical research protocols.
</li><li>Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.
</li><li>Coordinates monitoring visits
</li><li>Assists during FDA or internal audits.
</li><li>Operates sponsor devices such as perfusion machines.
</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

Nova Medical Services

<div>Overview 
 
The Clinical Research Coordinator (CRC) is responsible for assisting in the planning, coordination, and execution of clinical trials with strict adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), study protocols, and company/regulatory guidelines. The CRC supports investigators and research teams in ensuring patient safety, data integrity, and compliance throughout the clinical trial lifecycle&mdash;from initiation through close-out.<h3 class="jobSectionHeader"> 
Key Responsibilities</h3><ul><li>
Patient Coordination &amp; Support<ul><li>
Assist with coordinating all aspects of patient involvement from study initiation through completion.</li><li>
Schedule participant visits, procedures, and follow-ups according to protocol timelines.</li><li>
Provide clear communication and education to participants regarding study expectations, informed consent, and potential risks/benefits.</li></ul></li><li>
Study Operations &amp; Data Management<ul><li>
Organize and maintain all clinical trial documentation and regulatory binders in compliance with sponsor, IRB, and FDA requirements.</li><li>
Schedule and oversee collection of study data (labs, imaging, procedures, surveys, etc.).</li><li>
Observe study subjects and document findings, including adverse events and deviations, per regulatory and protocol standards.</li><li>
Assist in accurate entry, cleaning, and verification of data into electronic databases (EDC).</li><li>
Contribute to data analysis, preparation of progress reports, and submission of findings for sponsor and regulatory review.</li></ul></li><li>
Protocol &amp; Compliance Adherence<ul><li>
Ensure clinical trials are conducted following ICH/GCP, FDA regulations, IRB policies, and sponsor requirements.</li><li>
Monitor subject safety and report adverse events promptly.</li><li>
Maintain awareness of trial amendments and implement required changes into workflow.</li><li>
Participate in audits, monitoring visits, and inspections as required.</li></ul></li><li>
Administrative &amp; Logistical Support<ul><li>
Coordinate communication between investigators, research staff, sponsors, and study monitors.</li><li>
Track and manage study supplies, laboratory kits, and equipment inventory.</li><li>
Assist in organizing investigator meetings, staff training sessions, and study initiation visits.</li><li>
Support report writing, preparation of study presentations, and other sponsor-required deliverables.</li></ul></li></ul> 
Qualification<ul><li><ul><li>
Strong organizational and time management skills with ability to manage multiple trials simultaneously.</li><li>
Attention to detail and accuracy in data collection and documentation.</li><li>
Excellent interpersonal and communication skills to interact with patients, families, investigators, and regulatory bodies.</li><li>
Proficiency in Microsoft Office Suite, EDC systems, and clinical trial management software (CTMS).</li><li>
Ability to work independently while collaborating in a multidisciplinary team environment.</li></ul></li></ul><h3 class="jobSectionHeader">
Work Environment</h3><ul><li>
Fully on-site position</li><li>
Collaborative healthcare office environment</li><li>
Regular use of computer systems and documentation review</li></ul><h3 class="jobSectionHeader">
Schedule</h3>
Full-time | Monday &ndash; Friday 
Minimum 40 hours per week 
Pay rate $25 per hour
Benefits include:<ul><li>
Health Insurance</li><li>
Dental Insurance</li><li>
Vision Insurance</li><li>
401(k)</li><li>
Flexible Spending Account (FSA)</li><li>
Paid Time Off</li><li>
Professional development opportunities</li></ul>
If you are passionate about improving healthcare quality and ensuring compliance standards are met, we encourage you to apply and become part of our team.
People with a criminal record are encouraged to apply
Work Location: In person
This description indicates, in general terms, the type and level of work performed and responsibilities held by the team member(s). Duties described are not to be interpreted as being all-inclusive or specific to any individual team member.
No Third Party Agencies or Submissions Will Be Accepted.
Our company is committed to creating a diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. DFWP
Opportunities posted here do not create any implied or express employment contract between you and our company / our clients and can be changed at our discretion and / or the discretion of our clients. Any and all information may change without notice. We reserve the right to solely determine applicant suitability. By your submission you agree to all terms herein.
cfPwI3eG69</div>

Clinical Research Coordinator

Evolution Research Group

<div>About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
To support the continued growth of our Phase I business, ERG is building a new, stand-alone CLIA-certified and GLP-compliant safety laboratory located within our state-of-the-art Miami facility. This laboratory will be fully integrated with ERG&rsquo;s early-phase clinical operations and designed to provide high-quality, timely safety testing to support first-in-human and other early-phase clinical trials.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Assistant Laboratory Manager, Clinical Research (CLIA/GLP) is responsible for assisting operational leadership and direction for ERG&rsquo;s clinical safety laboratory. This position will play a key role in the build-out, launch, and ongoing operation of a new stand-alone laboratory supporting Phase I clinical studies. The Laboratory Manager will oversee laboratory personnel, workflows, quality systems, and compliance activities to ensure all laboratory operations meet CLIA, GLP, GCP, IRB, SOP, OSHA, and applicable state and local regulatory requirements.
Responsibilities:<ul><li>Assist with the build-out, start-up, and day-to-day operation of a CLIA-certified and GLP-compliant clinical research safety laboratory.</li><li>Assist Lab Manager with the directing and coordinating laboratory personnel to ensure quality, accuracy, and timeliness of laboratory testing and reporting.</li><li>Ensure compliance with CLIA, GLP, GCP, IRB requirements, SOPs, OSHA standards, and applicable regulatory requirements at all times.</li><li>Support CLIA and accreditation readiness activities, including inspections, audits, and corrective actions as needed.</li><li>Oversee quality control, quality assurance, and proficiency testing programs.</li><li>Manage laboratory testing menus, including evaluation of new assays, validation planning, and coordination with reference laboratories when appropriate.</li><li>Serve as a backup point of contact for sponsors and internal clinical teams, including participation in study initiation meetings.</li><li>Coordinate sample processing, storage, and shipment in accordance with protocol and sponsor requirements.</li><li>Oversee laboratory supply management, inventory control, and equipment maintenance.</li><li>Ensure accurate and timely electronic data transfers and laboratory data reporting to sponsors when required.</li><li>Maintain a safe, organized, and inspection-ready laboratory environment.</li></ul>
Skills and Qualifications:<ul><li>Bachelor of Science degree required.</li><li>Minimum of one (1) year of experience in an early-phase clinical research laboratory; additional experience strongly preferred.</li><li>State of Florida Supervisor License in all areas of testing performed, or ability to obtain.</li><li>Strong working knowledge of CLIA, GLP, GCP, and clinical research laboratory operations.</li><li>Demonstrated leadership and people-management skills.</li><li>Excellent organizational, analytical, and problem-solving abilities.</li><li>Ability to manage multiple priorities in a fast-paced early-phase research environment.</li><li>Strong communication skills with the ability to collaborate effectively with internal and external stakeholders.</li><li>Proficiency in Microsoft Office applications (Word, Excel, Outlook).</li></ul>
Join Our Team:<ul><li>
We foster innovative thinking, empowered decision‑making, and strong professional relationships. Learn more about us at www.ergclinical.com</li><li>
Evolution Research Group (ERG) is an equal opportunity employer and welcomes a diverse workforce.</li><li>
We are committed to fostering, cultivating &amp; preserving a culture of Diversity, Equity &amp; Inclusion.</li></ul></div>

Assistant Lab Manager

<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>

<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 .
The department of Medicine has an exciting opportunity for a full-time Clinical Research Nurse 3 to work onsite at the UHealth campus. The Clinical Research Nurse 3 ensures the integrity and quality of clinical research studies are maintained and conducted in accordance with practice guidelines, federal and sponsor regulations, and institutional policies and procedures. Additionally, the Clinical Research Nurse 3 plays a key role in the recruitment of participants and achievement of research objectives. This level serves as a lead to other clinical research nurses regarding day-to-day tasks and ensuring quality and safety of patients.
CORE JOB FUNCTIONS
<ul><li>Assesses, troubleshoots, and reports problems with data collection to appropriate managing staff.
</li><li>Identifies desired research outcomes and evaluates and monitors subjects&rsquo; responses.
</li><li>Conducts initiation visits and registers patients in clinical studies.
</li><li>Performs study data collection and entry using charts, correspondence, medical records, and relevant communications. Identifies and procures equipment and supplies needed to fulfill project requirements.
</li><li>Educates staff and subjects about protocols, treatment, possible side effects, and complications. May also collect and handle specimens as required by individual study protocols.
</li><li>Prepares and processes new research proposals and amendments and continually monitors applications and adverse events.
</li><li>Assists with study completion, data lock, study closeout, and archiving of study files to ensure completeness and continuity of all study data.
</li><li>Completes ongoing checks of clinical data entered on the case report forms to ensure accuracy and revises any discrepancies.
</li><li>Assists with training and onboarding of new clinical research nurses. Resolves issues and escalates matters of complexity to nursing leadership.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets.
</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
</li><li>Valid Florida RN license
</li><li>Minimum 6 years of relevant experience
</li></ul>Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Ability to communicate effectively in both oral and written form.
</li><li>Ability to work independently and/or in a collaborative environment.
</li></ul>#Li-TF1
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 Nurse 3

<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 .
The University of Miami UHealth Department of Urology has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work on-site at Desai Sethi Medical Center in Miami. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.
CORE JOB FUNCTIONS
<ul><li>Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
</li><li>Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
</li><li>Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
</li><li>Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
</li><li>Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
</li><li>Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
</li><li>Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Knows the contents and maintenance of study-specific clinical research regulatory binders.
</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
Clinical Research Coordinator 1 FTE would be delegated to support Dr. Nima Sharifi&rsquo;s clinical studies. Project-specific duties would include:
<ul><li>Performs screening/recruitment, obtains informed consent process and completes eligibility verification for applicable studies.
</li><li>Establishes and maintains communication with study participants, inter- and intra- departmental study team members, health care providers, sponsors and regulatory entities.
</li><li>Ensures study protocol adherence, including completion of protocol specific procedures and documentation.
</li><li>Maintains screening, enrollment, deviation, delegation of authority and other sponsor and/or protocol specific logs.
</li><li>Enters data onto case report forms and electronic data capture systems in accordance with ALCOA-C+ principles.
</li><li>Collects, processes, ships and tracks biological specimens following study protocol and regulatory guidelines.
</li><li>Reviews consent forms, sample collection tracking forms and clinical data to ensure quality and accuracy.
</li><li>Addresses data inconsistencies and provides responses to queries in a timely manner.
</li><li>Maintains inventory of study supplies and procures collection kits/supplies in anticipation of future needs.
</li><li>Attends research meetings with investigators, study team and site disease group; participates in scientific and clinical discussions relevant to the studies supported.
</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
Education:
Bachelor&rsquo;s degree in relevant field required
Certification and Licensing:
CCRC, CCRP, or CCRA preferred, but not required
Experience:
Minimum 1 year of relevant experience
Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li><li>Ability to work independently and/or in a collaborative environment.
</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>

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