clinical research coordinator Jobs in Miami

clinical research coordinator

clinical research coordinator 2 Jobs in Miami

clinical research coordinator 2

clinical research data specialist Jobs in Miami

clinical research data specialist

care coordinator

clinical research data assistant Jobs in Miami

clinical research data assistant

research coordinator

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 department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work on the UHealth 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 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 stand6ards 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
 
 
 
 <ul>
 <li>
 Supports recruitment, prescreening, and enrollment of participants across pulmonary, critical care, and sleep medicine clinical trials, including studies involving COPD, asthma, ILD, bronchiectasis, and sleep disorders.
 </li>
 <li>
 Coordinates and performs study visits and procedures in accordance with protocol requirements, including pulmonary function testing coordination (PFTs), six-minute walk tests, biospecimen collection, and patient-reported outcome assessments.
 </li>
 <li>
 Oversees collection, processing, storage, and shipment of biological specimens (blood, sputum, etc.) following sponsor protocols, IATA guidelines, and institutional policies.
 </li>
 <li>
 Maintains accurate and audit-ready regulatory binders and study files in accordance with UM, sponsor, and FDA/ICH-GCP requirements.
 </li>
 <li>
 Supports investigational product (IP) handling and accountability (when applicable), including coordination with IDS/pharmacy and ensuring proper documentation per protocol.
 </li>
 <li>
 Monitors, documents, and reports adverse events (AEs/SAEs), protocol deviations, and unanticipated problems, ensuring timely reporting to sponsors, IRB, and regulatory bodies.
 </li>
 <li>
 Implements protocol amendments, including updating study documents, revising workflows, and reconsenting participants as needed under PI supervision.
 </li>
 <li>
 Coordinates study startup and ongoing operations, including assisting with site initiation visits (SIVs), monitoring visits, and audit readiness activities.
 </li>
 <li>
 Tracks study progress, enrollment, and data entry timelines; ensures investigators are regularly updated and milestones are met across multiple active protocols.
 </li>
 <li>
 Serves as a point of contact for sponsors, CROs, monitors, and internal collaborators; supports effective communication and issue resolution across cross-functional teams.
 </li>
 <li>
 Performs timely and accurate data entry into EDC systems (e.g., Medidata, REDCap), resolves data queries, and ensures source documentation is complete and consistent.
 </li>
 <li>
 Collaborates with clinical teams (physicians, RTs, nurses) to coordinate protocol-required procedures during routine patient care and research visits.
 </li>
 <li>
 Ensures compliance with all applicable regulatory requirements, including FDA, ICH-GCP, HIPAA, and institutional policies governing human subjects research.
 
 
 
 </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>
 Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
 </li>
 <li>
 Ability to work collaboratively with others and contribute to a team environment.
 </li>
 <li>
 Skilled in using office software, technology, and relevant computer applications.
 </li>
 <li>
 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

LCC Medical Research Institute, LLC

Job OverviewWe are seeking an experienced Clinical Research Coordinator to join our clinical research team. The ideal candidate must have at least 3 years of clinical research experience and be fully bilingual in English and Spanish. This role requires strong organization, patient communication skills, attention to detail, and the ability to support day-to-day study operations in compliance with protocol, GCP, and site procedures.Responsibilities<ul><li>Coordinate daily clinical trial activities from screening through follow-up.</li><li>Review protocols and support study startup, recruitment, prescreening, and scheduling.</li><li>Obtain and document informed consent as delegated and permitted.</li><li>Maintain accurate source documentation and study records.</li><li>Enter and resolve data in EDC systems.</li><li>Coordinate subject visits, labs, ECGs, vitals, questionnaires, IP accountability support, and study-specific procedures.</li><li>Communicate with participants, caregivers, sponsors, CROs, monitors, vendors, and investigators.</li><li>Prepare for monitoring visits and assist with query resolution.</li><li>Track recruitment, enrollment, visit windows, deviations, and study action items.</li><li>Ensure study activities follow GCP, protocol requirements, and site SOPs.</li></ul>Requirements<ul><li>Minimum 3 years of experience as a Clinical Research Coordinator or similar clinical research role.</li><li>Fluent bilingual communication skills in English and Spanish, spoken and written.</li><li>Experience with sponsor/CRO monitoring visits, EDC systems, source documentation, and regulatory binders.</li><li>Strong knowledge of GCP and clinical trial conduct.</li><li>Excellent organization, follow-up, and time-management skills.</li><li>Comfortable communicating with patients and study participants.</li><li>Ability to work on-site and manage multiple studies/tasks.</li><li>Proficiency with Microsoft Office or Google Workspace.</li></ul>Preferred Qualifications<ul><li>Experience in CNS, psychiatry, neurology, metabolic, nephrology, or outpatient studies.</li><li>Phlebotomy, ECG, vitals, lab processing, or IATA training.</li><li>CCRC certification or other clinical research certification.</li><li>Experience with recruitment and prescreening workflows.</li></ul>CompensationDepending on experience.Schedule Monday to Friday, [8am to 5 pm]. Occasional flexibility may be required based on study visits.How to Apply Please submit your resume through Indeed. Qualified candidates may be contacted for a phone screening and interview.Pay: Up to $72,000.00 per yearWork Location: In person

Clinical Research Coordinator

<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 Public Health has an exciting opportunity for a full time Research Support Specialist to work in Miami, FL. 
 
The Caban-Martinez Lab in the UM Department of Public Health Sciences seeks a Research Support Specialist with human research experience to join its growing environmental and occupational health research laboratory. The Firefighter Cancer Initiative (www.Sylvester.org/firefighters) is focused on cancer control and prevention in the firefighter work environment. The Firefighter Cancer Initiative projects conducted in the Caban-Martinez lab are both office- and field-based where the research team engages firefighters in the collection of health surveys, biological samples, and exposures assessments. The candidate will work in a team environment, participate in and leading components of the firefighter cancer initiative projects, including participant recruitment, enrollment, participant adherence to research protocols, and biological samples collection, and tracking on project metrics. Will maintain excellent relationships with firefighter community partners and study participants. The candidate will have opportunities to present and speak at professional meetings and support the development and publication of project research findings. This job may require evening and weekend hours and job duties may take place at multiple fire department locations throughout Florida and the United States. The Research Support Specialist performs a variety of duties involved in the collection, compilation, and documentation of research data related to the assigned research studies. The incumbent also assists with the implementation of daily study activities and provides statistical support to these activities.
 
 
Core responsibilities:
<ul><li>Researches, collects, analyzes, and synthesizes data and maintains databases.
</li><li>Conducts quality assurance checks, reports on the status of research activities, and submits monthly activity logs for protocol.
</li><li>Organizes and coordinates community working group meetings for protocol activities.
</li><li>Serves as primary point of contact for community partners and supervises and oversees research data collection at protocol venues in the community.
</li><li>Reviews study progress, identifies areas of opportunity, and recommends solutions.
</li><li>Prepares and updates study research procedures manuals.
</li><li>Assists with the preparation of grant proposals by processing regulatory documents for all institutions and offices involved.
</li><li>Contributes to the publication and presentation of significant results and writes and edits material for publication and presentation.
</li><li>Maintains research files and responds to phone calls on the research study phone line.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets.
</li></ul>Department Specific Functions:
Job Description Summary:
<ul><li>The Research Support Specialist performs a variety of duties involved in the collection, compilation, and documentation of research data related to assigned research studies. Works closely with the faculty investigator and the primary investigator in the implementation of daily study activities. Provides statistical support for research projects.
</li><li>Researches and collects data, maintains databases, interprets, synthesizes, and analyzes data using scientific or statistical techniques; conducts quality assurance checks with research data manager; reports on status of research activities and submits monthly activity logs for protocol.
</li><li>Assists in the organization and coordination of community working group meetings for protocol activities including the development of protocol timelines, meeting agendas, resource materials, and oral presentations for study-related work; serves as primary point of contact for community partners; supervises and oversees research data collection at protocol venues in the community.
</li><li>Collaborates with faculty investigators to successfully administer the study protocols, reviews study progress and recommends solutions to faculty investigators; prepares weekly progress reports for presentation and review at team meetings, and coordinates research team meetings with the assistance of the faculty investigators and principal investigator.
</li><li>Implements day-to-day project activities including the preparation of research reports and the participation in dissemination activities; prepares study research procedures manual.
</li><li>Assists with the preparation of grant proposals by processing regulatory documents for all institutions and offices involved, including IRB, JHS, CTO, and UMH.
</li><li>Contributes to the publication and/or presentation of significant results; writes and edits material for publication and presentation.
</li><li>Conducts data entry, maintains research files and responds to phone calls on the research study phone line.
</li></ul>Job Functions
<ul><li>Under the guidance of the Firefighter Cancer Initiative (FCI) Deputy Director, Dr. Caban-Martinez and the FCI scientists, the Research Support Specialist will work on key deliverables which include participant enrollment and management within the research projects.
</li><li>In-person and remote survey and biological sample collection, monitoring and calling participants for study protocol adherence.
</li><li>Organizing and producing study-related materials for study participants self-sampling and blood collection.
</li><li>Delivers study-related surveillance metrics to Firefighter Cancer Initiative team.
</li><li>Provides detailed monitoring and interventions to participants.
</li><li>Assists in the submission of and interprets research protocols and procedures (e.g., IRB).
</li><li>Participates in the publication of significant results, including authorship of scientific monographs.
</li><li>Prepares and presents significant study findings at educational conferences and/or scientific meetings.
</li><li>Ensures all research is undertaken according to good research practice and guidance.
</li><li>Willingness to travel to attend meetings or for data collection.
</li><li>Researches, collects, analyzes, and synthesizes data and maintains databases.
</li><li>Conducts quality assurance checks, reports on the status of research activities, and submits monthly activity logs for protocol.
</li><li>Organizes and coordinates community working group meetings for protocol activities.
</li><li>Serves as primary point of contact for community partners and supervises and oversees research data collection at protocol venues in the community.
</li><li>Reviews study progress, identifies areas of opportunity, and recommends solutions.
</li><li>Prepares and updates study research procedures manual.
</li><li>Assists with the preparation of grant proposals by processing regulatory documents for all institutions and offices involved.
</li><li>Contributes to the publication and presentation of significant results and writes and edits material for publication and presentation.
</li><li>Maintains research files and responds to phone calls on the research study phone line.
</li>Adheres to University and unit-level policies and procedures and safeguards University assets. 
<li>
</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><ul><li>Minimum 2 years of relevant experience preferred
</li></ul></li><li>Research, Ethics, and Compliance Training (CITI Program) preferred.
</li><li>Phlebotomy experience not required but preferred.
</li><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><li>Knowledge in the use of REDCap, preferred.
</li><li>Ability to communicate effectively in both oral and written form.
</li><li>Ability to handle difficult and stressful situations with professional composure.
</li><li>Ability to maintain effective interpersonal relationships.
</li><li>Ability to understand and follow instructions 
</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>

Research Support Specialist

Florida International University

<div>
 
 
 About FIU
 
 
 
 
 Florida International University is a Top 50, preeminent public research university with 55,000 students from all 50 states and more than 140 countries, as well as an alumni network of more than 340,000. Located in the global city of Miami, the university offers more than 200 degree programs at the undergraduate, graduate and professional levels, including medicine and law. FIU faculty are leaders in their fields and include National Academy members, Fulbright Scholars and MacArthur Genius Fellows. A Carnegie R1 institution, FIU drives impactful research in environmental resilience, health and technology and innovation. Home to the Wall of Wind and Institute of Environment, FIU stands at the forefront of discovery and innovation. With a focus on student success, economic mobility and community engagement, FIU is redefining what it means to be a public research university.
 
 
 
 
 Job Summary
 
 
 
 
 Under supervision of the Program Director, performs a variety of national security non-laboratory research and clerical tasks to assist investigators in the collection, verification, and compilation of research information for the Security Research Hub.
 
 
 <ul>
 <li>
 Works closely with the Director of National Security in organizing, monitoring, and coordinating research initiatives specifically with the Security Research Hub.
 </li>
 <li>
 Coordinates research programming relating to Cuba's Military and Humanitarian efforts.
 </li>
 <li>
 Prepares screening assessments for research proposals and participants on the project.
 </li>
 <li>
 Assists in the compilation and distribution of reports to key stakeholders related to research findings.
 </li>
 <li>
 Drafts collaboration documents to formalize joint research efforts with external domestic and international partners.
 </li>
 <li>
 Works with the Office of Research and Economic Development to track the status of pending agreements.
 </li>
 <li>
 Performs other duties as assigned.
 
 
 </li>
 </ul>
 
 
 Minimum Qualifications
 
 
 
 
 <ul>
 <li>
 High school diploma with three (3) years of experience; OR two (2) years of post-secondary education with one (1) year of experience; OR an equivalent combination of relevant education and/or experience.
 
 
 </li>
 </ul>
 
 
 Departmental Requirements
 
 
 
 
 <ul>
 <li>
 Must be a U.S. Citizen.
 
 
 </li>
 </ul>
 
 Job Category
 
 
 
 <ul>
 <li>
 Staff
 
 
 </li>
 </ul>
 
 Advertised Salary
 
 
 
 <ul>
 <li>
 $33,000 - $35,000
 
 
 </li>
 </ul>
 
 Work Schedule
 
 
 
 Begin time: 8:30 AM
 
 
 End time: 5:00 PM
 
 
 
 
 Pre-Employment Requirements
 
 
 
 
 <ul>
 <li>
 Criminal Background Check
 
 
 </li>
 </ul>
 
 
 Other Information
 
 
 
 
 <ul>
 <li>
 Ability to work flexible hours as needed.
 </li>
 <li>
 Access to some DOE facilities and U.S. Military Installations require U.S. citizenship
 </li>
 <li>
 Ability to travel locally
 </li>
 <li>
 This position is funded by an external source (e.g. a grant or contract)
 
 
 </li>
 </ul>
 
 
 How To Apply
 
 
 
 
 
 Prospective Employee
 
 
 
 If you have not created a registered account, you will be asked to create a username and password for use of the system. It is recommended that you provide an active/valid e-mail account as that will be the main source of communication regarding your status within the process. In this account, you are able to track your applicant status in "
 
 My Applications
 
 ".
 
 
 
 
 To be considered eligible for the position as an internal candidate, departmental staff must meet minimum requirements of the position and be in good performance standing.
 
 
 
 
 Before you begin the process, we recommend that you are prepared to attach electronic copies of your resume, cover letter or any other documents within the application process. It is recommended that you combine your cover letter and resume/curriculum vitae into one attachment. Attached documents should be in Microsoft Word or PDF format. All applicants are required to complete the online application including work history and educational details (if applicable), even when attaching a resume.
 
 
 <ul>
 <li>
 This posting will close at 12:00 am of the close date.
 
 
 </li>
 </ul>
 
 
 How To Apply
 
 
 
 
 
 Current Employee
 
 
 
 As a current employee, you must log into Employee Self Service (ESS) to apply for this and any other internal career opportunity of interest. In this account, you are able to track your applicant status in "
 
 My Applications
 
 ".
 
 
 
 
 To be considered eligible for the position as an internal candidate, departmental staff must meet minimum requirements of the position and be in good performance standing.
 
 
 
 
 Before you begin the process, we recommend that you are prepared to attach electronic copies of your resume/ curriculum vitae, cover letter or any other documents within the application process. It is recommended that you combine your cover letter and resume into one attachment. Attached documents should be in Microsoft Word or PDF format.
 
 
 <ul>
 <li>
 This posting will close at 12:00 am of the close date.
 
 
 </li>
 </ul>
 
 
 How To Claim Vet Preference
 
 
 
 
 Since 1945, the Florida Legislature has made a provision to give preference in the hiring process to United States war veterans in recognition of their military, naval, or air service who meet specific conditions. The conditions are as follows:
 
 
 <ul>
 <li>
 Veterans with a VA service-connected disability
 </li>
 <li>
 Spouses of veterans with permanent and total service-connected disability
 </li>
 <li>
 Honorably discharged veterans with wartime service.
 </li>
 <li>
 Unmarried widow or widower of a veteran who died as a result of a service-connected disability
 </li>
 <li>
 A veteran who has served in a qualifying campaign or expedition for which a campaign badge has been authorized, to include the Global War on Terrorism Expeditionary Medal.
 
 
 </li>
 </ul>
 Florida International University honors this policy and will comply with Veterans' Preference guidelines when filling staff positions. Any applicant claiming Veterans' Preference will be required to attach a DD214 with each application submitted for verification.
 
 
 If there are any questions concerning Veterans' Preference, please contact Talent Acquisition &amp; Management by calling 305-348-2500.
 
 
 For additional information on Veterans' Preference, visit http://www.floridavets.org/.
 
 
 
 Disclosures
 
 
 
 
 Clery Notice
 
 
 
 In compliance with the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act, the University Police department at Florida International University provides information on crimes statistics, crime prevention, law enforcement, crime reporting, and other related issues for the past three (3) calendar years. The FIU Annual Security report is available online at: https://police.fiu.edu/download/annual-security-fire-safety-report/.
 
 
 To obtain a paper copy of the report, please visit the FIU Police Department located at 885 SW 109th Avenue, Miami, FL, 33199 (PG5 Market Station).
 
 
 
 Pay Transparency
 
 
 
 Florida International University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
 
 
 
 Notice of Non-Discrimination
 
 
 
 FIU is a State University System of Florida member, Equal Opportunity, Equal Access, and Affirmative Action Employer for individuals with disabilities and veterans. All qualified applicants will receive consideration for employment decisions, programs, and events without regard to race, color, religion, sex, age, national origin, disability, or protected veteran status. For inquiries regarding non-discrimination, contact FIU's Office of Civil Rights at 305.348.2785 or email ocr@fiu.edu.
 
 
 
 Reasonable Accommodation Statement
 
 
 
 Should you need an ADA accommodation to participate in a University event, program, or activity or need to request materials in an accessible format, please contact FIU's Office of Civil Rights (OCR) at 305-348-2785 or accommodations@fiu.edu. All requests for ADA accommodation or accessible materials for this event must be submitted to OCR at least seven (7) business days prior to the event or at the earliest possible opportunity.
</div>

Research Assistant (Jack D. Gordon Institute for Public Policy)

<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 Surgery is currently seeking a temporary Clinical Research Data Specialist to work part time hours in Miami.
CORE JOB SUMMARY
 
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
 
 
CORE JOB FUNCTIONS
<ul><li>Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
</li><li>Manages a workload of studies commensurate to level of experience
</li><li>Answers data clarifications (i.e., data queries) for each study.
</li><li>Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
</li><li>Develops source data worksheets specific to each assigned study.
</li><li>Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
</li><li>Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
</li><li>Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.
</li><li>Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
</li><li>Assists multidisciplinary team in research activities.
</li><li>Maintains study binders and filings according to protocol requirements and department policy.
</li><li>Adheres to all UM and department policies and procedures.
</li><li>Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
</li><li>Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
</li><li>Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
</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>High School Diploma or equivalent/relevant experience, certification or license
</li><li>No previous experience required
</li><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:
Part time
Employee Type:
Temporary</div>

Clinical Research Data Specialist

<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 SCCC has an exciting opportunity for a Full-Time Manager, Quality Assurance - Remote to work at the UHealth campus in Miami, Fl.
CORE JOB SUMMARY
The Manager, Quality Assurance conducts routine, focused, and directed audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines, and research site specific standard operating procedures. The incumbent on this position advises appropriate institutional officials of deficiencies, and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented. The Manager, Quality Assurance also trains and mentors quality assurance auditors.
CORE JOB FUNCTIONS
<ul><li>Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements, and conducts inquiries of laboratories and research protocols.
</li><li>Prepares reports of investigations and inquiries for internal or external use. Assists in the preparation and presentation of educational programs.
</li><li>Conducts the preparation of research teams for FDA or other regulatory agency audits.
</li><li>Assists research teams with required written responses to observations resulting from audits conducted by regulatory agencies.
</li><li>Reviews audit reports and plans of quality assurance auditors.
</li><li>Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research and recommends changes to administrative policies and procedures.
</li><li>Creates, revises, and maintains internal policies and standard operating procedures, as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.
</li><li>Assists with the preparation of annual reports, summarizing efforts taken and changes to be implemented at both University and department levels.
</li><li>Maintains quality assurance related databases and electronic and paper audit files.
</li><li>Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.
</li><li>Ensures employees are trained on controls within the function and on University policy and procedures.
</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
Experience: Minimum 5 years relevant experience
Knowledge, Skills and Attitudes:
<ul><li>Ability to maintain effective interpersonal relationships
</li><li>Ability to communicate effectively in both oral and written form
</li><li>Skill in collecting, organizing, and analyzing data
</li><li>Ability to recognize, analyze, and solve a variety of problems
</li><li>Ability to exercise sound judgment in making critical decisions
</li></ul><h1 class="jobSectionHeader">DEPARTMENT ADDENDUM
</h1>Primary:
<ul><li>Develops, verifies, and implements procedures to accomplish SCCC research quality improvement goals.
</li><li>Reviews research protocol compliance and participant adherence to protocol: Reviews documentation of patient/participant screening procedures completed by Principal Investigator and CRS staff and reviews relevant medical information from patient clinic charts/medical records. Reviews logs/progress reports to track protocol compliance for both currently enrolled as well as follow-up patients/participants.
</li><li>Determines data to be collected and provides QC of Clinical Trial Management System (CTMS): Develops forms for collecting/summarizing data. Ensures data integrity and consistency in CTMS and written records. Supports corrections/queries resolution of audits/monitor visits and takes action to develop and implement CAPAs as needed. Establishes/maintains contact with CRS employees, health care providers, community agencies and study sponsors.
 </li><li>Updates appropriate agencies (such as sponsors, IRB, etc.) regarding status of research projects.
</li><li>Provides education to staff about research protocols.
</li></ul>Education:
<ul><li>Supports the development and implementation of a CRS employee orientation program. Participates in the implementation coordination and execution of the continuing education program for CRS employees.
</li><li>Assists with the design, conduct, and implementation of education and training programs for investigators, clinical research coordinators, and research staff in general and with specific emphasis on cooperative group trials.
</li></ul>Quality Initiatives:
<ul><li>Works closely with the CRS, Director Quality Assurance Unit. other CRS staff, and outside quality control/quality assurance personnel, on overseeing all CAPA initiatives.
</li><li>Provides support for, and coordination of quality initiatives primarily for the National Group protocols and non-IND Investigator Initiated Studies. This includes working with CRS staff to address data timeliness and query resolution.
</li><li>Supports the development and management of the CRS SOP portfolio.
 </li><li>Participates in the development of general goals, process improvement plans, and training activities related to research compliance.
</li><li>Works closely with the CRS Director, Quality Assurance Unit to develop and enhance systems and processes as required to improve efficiencies, compliance, and quality of the CRS operation.
</li></ul>Department Specific Qualifications
Certification and Licensing:
<ul><li>Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates or obtained within 1 year of hire.
</li></ul>Experience:
<ul><li>Medical and/or science education strongly preferred.
</li></ul>Knowledge, Skills and Attitudes:
<ul><li>Oncology and cooperative group clinical trial experience preferred.
</li><li>High-level interpersonal skills are required.
</li><li>Excellent English oral and written communication skills required.
</li><li>Thorough understanding of Good Clinical Practice guidelines and the Code of Federal Regulations required.
</li><li>Proficient with Microsoft Office Suite including Excel and Power Point.
</li><li>Knowledge of medical terminology.
</li><li>Ability to manage multiple tasks simultaneously.
</li><li>Attention to detail &amp; accuracy.
</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>

Manager, Quality Assurance

<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 Psychiatry has an exciting opportunity for a full time Research Associate 1 to work in Miami, FL.
 
 
 Core responsibilities:
 
 
 <ul>
 <li>
 Understands and interprets research protocols and procedures.
 </li>
 <li>
 Participates in the publication of significant results.
 </li>
 <li>
 Maintains an overview of relevant research findings.
 </li>
 <li>
 Ensures all research is undertaken according to good research practice.
 </li>
 <li>
 Keeps abreast of current publications relative to methods, techniques, and developments within the area of research.
 </li>
 <li>
 Collects, prepares, analyzes, dissects, and evaluates specimens or tissue cultures.
 </li>
 <li>
 Operates and maintains laboratory equipment.
 </li>
 <li>
 Performs a variety of routine assays, tests, and studies.
 </li>
 <li>
 Performs calculations to complete research test results, collects data, and performs statistical analysis of laboratory results.
 </li>
 <li>
 Adheres to University and unit-level policies and procedures and safeguards University assets.
 
 
 
 </li>
 </ul>
 
 Department Specific Functions
 
 
 
 <ul>
 <li>
 Understanding and Interpreting Research Protocols: Interpret and comprehend research protocols and procedures relevant to assigned projects. This includes ensuring clarity regarding experimental methodologies, ethical considerations, and data collection procedures.
 </li>
 <li>
 Ensure that all research activities are conducted in accordance with established good research practices, ethical guidelines, and regulatory standards. This includes maintaining integrity in data collection, following proper experimental procedures, and safeguarding the welfare of research subjects.
 </li>
 <li>
 Collect, prepare, and document biomarker data as required for research purposes. This involves performing laboratory procedures with precision, attention to detail, and adherence to safety protocols to ensure accurate and reliable results.
 </li>
 <li>
 Perform a variety of neuropsychological batteries as directed by research protocols. This may include conducting tests, recording data, analyzing results, and documenting findings in accordance with established procedures and timelines.
 
 
 
 </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>
 No prior experience required
 </li>
 <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>

Research Associate 1

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