clinical research coordinator 1

clinical research coordinator 1 (a) Jobs in Miami

clinical research coordinator 1 (a)

clinical research coordinator 2 Jobs in Miami

clinical research coordinator 2

data analyst 1

clinical research coordinator 1 a

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 1 to work on the UHealth campus. 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>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 1 year of relevant experience required
</li><li>Bilingual in English and Spanish highly desired
</li><li>Phlebotomy certification highly desired, or requires completion of a formal Phlebotomy training program within 30 days of hire.
</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>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 1 (A)

<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 1
The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at the UHealth Medical Campus. The Clinical Research Coordinator 1 (A) serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines.
Core Responsibilities
<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
<ul><li>Attend the scheduled clinical research meetings with Clinical Research Supervisor and fellow CRCs.
</li><li>Assists in keeping accurate accountability of clinical research costs: reimbursement/payments to study participants, payments to third parties, including but not limited to the costs of conducting clinical research at JHS, University of Miami facilities (Radiology, Research Pharmacy, Radiology, Laboratory, Clinical and Translational Research Services).
</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>Minimum 1 year 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>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>

Clinical Research Coordinator 1

Southeastern Health Management

Position Title Oncology Clinical Research Coordinator (CRC) Position Type Full-Time Reports To Research Director / Principal Investigator Position Summary Total Health and Research Center (THRC) is seeking an experienced Oncology Clinical Research Coordinator (CRC) to support Phase IIV clinical trials in oncology and other therapeutic areas. The Oncology CRC will be responsible for the day-to-day coordination of clinical trials, ensuring protocol compliance, patient safety, regulatory adherence, and high-quality data collection. Key Responsibilities Study Coordination - Coordinate all aspects of clinical trials from site initiation through study close-out - Conduct protocol review and feasibility assessments - Prepare site for site qualification visits, site initiation visits, and monitoring visits - Ensure compliance with FDA, ICH-GCP, sponsor protocols, and IRB requirements Patient Recruitment and Screening - Identify and recruit eligible patients through EMR and physician referrals - Screen potential participants according to protocol inclusion/exclusion criteria - Schedule and coordinate screening procedures, labs, imaging, and biopsies - Conduct or assist with informed consent process Participant Management - Coordinate all study visits and treatment cycles - Track protocol visit schedules and treatment windows - Monitor participants for adverse events and safety signals - Ensure accurate concomitant medication tracking Oncology Treatment Coordination - Coordinate with infusion staff for investigational drug administration - Verify dose calculations and treatment schedules - Coordinate safety labs and pre-treatment requirements Data Management - Enter study data into EDC systems - Maintain source documentation and regulatory binders - Resolve data queries from sponsors and CROs Regulatory Compliance - Maintain regulatory documents including IRB submissions and protocol amendments - Ensure adherence to Good Clinical Practice (GCP) guidelines Monitoring and Audits - Prepare for monitoring visits, sponsor audits, and FDA inspections - Address monitoring findings and implement corrective actions Required Qualifications Education Bachelors degree in Nursing, Life Sciences, Health Sciences, Clinical Research, or related field. Experience Minimum 23 years experience coordinating oncology clinical trials. Experience with oncology protocols, infusion studies, RECIST imaging, and serious adverse event reporting preferred. Certifications (Preferred) - ACRP Certified Clinical Research Coordinator (CCRC) - SOCRA CCRP Certification - GCP Certification - Human Subjects Protection Training (CITI) Required Skills - Strong understanding of oncology clinical trial operations - Knowledge of ICH-GCP and FDA regulations - Experience with EDC systems - Strong organizational and time-management skills - Excellent patient communication skills

Oncology Clinical Research Coordinator (NOT REMOTE)

Care Access

<div><div>About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

To learn more about Care Access, visit www.CareAccess.com.</div><h3 class="jobSectionHeader">
How This Role Makes A Difference</h3>
<div>The Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members.
</div>
<div></div><div>The Travel Clinical Research Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.
</div><h3 class="jobSectionHeader">How You'll Make An Impact</h3>
<div><ul><li>Study Preparation:
<ul><li>Ability to understand and follow institutional SOPs
</li><li>Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
</li><li>Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
</li><li>Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
</li><li>Assist with planning and creation of appropriate recruitment and marketing materials
</li><li>Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.</li>
<li>Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
</li><li>Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
</li><li>Assist in the creation or review of protocol specific source documents
</li><li>Determine facility, equipment and outsource vendor requirements and availability
</li><li>Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance</li>
<li>Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
</li></ul></li><li>Study Management:
<ul><li>Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.</li>
<li>Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
</li><li>Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
</li><li>Collect and evaluate concomitant medications
</li><li>Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.</li>
<li>Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
</li><li>Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
</li><li>Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
</li><li>Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion
</li><li>Maintain effective relationships with study participants and other Care Access personnel
</li><li>Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management
</li><li>Strong and clear communication skills, both verbally and in writing
</li><li>Accept accountability for actions and function independently
</li></ul></li><li>Patient Coordination:
<ul><li>Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
</li><li>Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial
</li><li>Administer delegated study questionnaires, where appropriate.
</li><li>Collect and evaluate medical records with the support of medically qualified members of the study team.</li>
<li>Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
</li><li>Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
</li><li>Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
</li><li>Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)</li>
<li>Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
</li><li>Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
</li><li>Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
</li><li>Monitor patient progress on study medication
</li></ul></li><li>Documentation:
<ul><li>Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
</li><li>Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
</li><li>Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
</li><li>Accurately transcribe data to CRF or EDC.
</li><li>Resolve data management queries and correct source data as needed
</li><li>Record protocol exemptions and deviations as appropriate with sponsor.
</li><li>Complete Note(s)-to-File for patient chart and regulatory filing if necessary
</li><li>Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
</li><li>Maintain copies of patient-specific correspondence in source charts
</li><li>Assist regulatory personnel with completion of continuing/final review reports
</li></ul></li><li>Perform other duties as assigned.
</li></ul></div><h3 class="jobSectionHeader">The Expertise Required</h3>
<div><ul><li>Bilingual proficiency required: Must be fluent in both English and Spanish, with the ability to effectively communicate (written and verbal) in both languages.</li>
<li>Excellent working knowledge of clinical trials, medicine and research terminology
</li><li>Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
</li><li>Ability to communicate and work effectively with a diverse team of professionals
</li><li>Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
</li><li>Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.</li>
<li>Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.</li>
<li>Critical thinker and problem solver
</li><li>Friendly, outgoing personality; maintain a positive attitude under pressure
</li><li>High level of self-motivation and energy
</li><li>Excellent professional writing and communication skills
</li><li>Ability to work independently in a fast-paced environment with minimal supervision
</li></ul>Certifications/Licenses, Education, and Experience:
<ul>
<li>BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
</li><li>RN or LPN preferred
</li><li>Research Professional Certification- CRCC or exam eligibility preferred
</li><li>A minimum of 3 to 4 years Clinical Research experience
</li><li>A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
</li></ul></div><h3 class="jobSectionHeader">How We Work Together</h3>
<ul><li>Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide.
<ul><li>Duties may require travel for a two-week stretch, followed by one week home.
</li><li>Frequency and length of travel may depend on the length and location of study.</li>
<li>Must possess a valid driver's license and be able to operate rental vehicles provided for work-related travel.</li>
</ul>
</li></ul><div>The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members.
<h3 class="jobSectionHeader">
Benefits &amp; Perks (US Full Time Employees)</h3>
<ul><li>Paid Time Off (PTO) and Company Paid Holidays</li>
<li>100% Employer paid medical, dental, and vision insurance plan options</li>
<li>Health Savings Account and Flexible Spending Accounts</li>
<li>Bi-weekly HSA employer contribution</li>
<li>Company paid Short-Term Disability and Long-Term Disability</li>
<li>401(k) Retirement Plan, with Company Match</li>
</ul>
</div><div>Diversity &amp; Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com

Mandatory Employer Disclosures: 
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. 
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment. 
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment. 
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29&ndash;38 of Title 28 of the Rhode Island General Laws. 
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.</div></div>

Travel 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 OBGYN has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work in Miami, FL. 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.
<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 JOB FUNCTIONS
<ul><li>Reviews and administers informed consent forms to study participants.
</li><li>Schedules patients for research-related visits and contacts patients for clinical follow-up requirements.
</li><li>Coordinates activities between departments to accomplish study goals.
</li><li>Assists investigators in study related tasks, follow-up visits, procedures, and assessments as required per protocol
</li><li>Maintains updated records of long-term follow-up participants, collect and required data on a timely manner respond to sponsor queries Retains records of payments to study participants.
</li><li>Completes patients&rsquo; data forms and reviews medical charts for patients&rsquo; vital signs and other medical data to complete case report forms.
</li><li>Complete and manage regulatory binder documents according to protocol and institutional requirement
</li><li>Complete study related activities such as device management, device insertion and removal.
</li><li>Maintains records of study results and study participants. Keeps an active pool of study candidates to ensure availability.
</li><li>Coordinates the implementation of multiple complex clinical research protocols.
</li><li>Develops SOPs and templates with guidance from the PI/Clinical Research Nurse Manager.
</li><li>Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
</li><li>Manages and performs sample collection, processing, packing, and shipping according to protocol, applicable standards, and regulations.
</li><li>Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations.
</li><li>Develops and implements preventive/corrective actions.
</li><li>Develops, disseminates, and assures adherence to study-related clinical research best practices
</li><li>Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
</li><li>Organizes/manages site visits and internal/external auditing activities as assigned.
</li><li>Coordinates research team meetings; assures communications across-the-board.
</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>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><li>Refer to department description for applicable certification requirements
</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>This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.
#LI-NN1
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

<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 .
Core Job Summary
The ELSI Research Associate supports interdisciplinary research and programmatic activities focused on the ethical, legal, social, and policy implications (ELSI) of research, innovation, and emerging practices within a biomedical or health-related environment. The role contributes to the design, execution, and dissemination of ELSI-focused research by applying ethical analysis, policy evaluation, and qualitative research methodologies in collaboration with faculty and cross-functional partners.
Core Job Functions
1. Designs, organizes, and conducts qualitative and/or mixed-methods research examining ethical, legal, social, and policy dimensions relevant to assigned research initiatives.
 
2. Conducts systematic, scoping, and background literature reviews related to ELSI issues in research, health care, or innovation contexts.
 
3. Performs comparative policy and legal research and analysis relevant to biomedical research, health systems, or emerging technologies.
 
4. Prepares research outputs including reports, presentations, and scholarly manuscripts for co-authored publication and dissemination in academic, policy, or stakeholder-facing venues.
 
5. Contributes to the development and preparation of grant applications, including drafting research content, literature syntheses, and supporting documentation.
 
6. Coordinates regulatory and research compliance activities, including preparation, submission, and maintenance of IRB protocols, amendments, continuing reviews, and communication with oversight offices.
 
7. Supports project management activities, including data organization, documentation, timeline tracking, and coordination across interdisciplinary teams.
 
8. Adheres to University and unit-level policies and procedures and safeguards University assets. 
 
Knowledge, Skills and Attitudes
<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>Department Specific Functions
A full-time ELSi Research Associate position is available to support research on the ethical, legal, and social implications (ELSI) of advances in biomedicine, health policy, and emerging technologies.
The successful candidate will join an interdisciplinary team within the Institute for Bioethics and Health Policy (IBHP) at the University of Miami Leonard M. Miller School of Medicine. The bioethics and policy research program is led by Rosario Isasi, JD, MPH, Director of the IBHP.
The Institute for Bioethics and Health Policy (IBHP) at the University of Miami Miller School of Medicine advances ethics and policy scholarship across research, clinical care, and public health. Its interdisciplinary team collaborates nationally and globally to promote ethical reflection and policy innovation through three core pillars - Innovative Research &amp; Scholarship,
Integrated Ethics Service &amp; Consultation and Ethics Education &amp; Leadership Development. https://bioethics.miami.edu
 
 
Responsibilities
<ul><li>Design and conduct empirical research on ethics and policy using qualitative (e.g., interviews, focus groups, content analysis) and/or quantitative (e.g., survey design, data analysis) methods.
</li><li>Lead or contribute to social science and ELSI studies, including systematic and scoping reviews, on emerging bioethical, policy, and governance, in areas such as genomics, regenerative medicine, artificial intelligence, health data, and biomedical innovation within research and clinical settings.
</li><li>Contribute to ethics education and curriculum development, supporting training initiatives and educational activities aligned with IBHP&rsquo;s education mission.
</li><li>Prepare reports, scholarly manuscripts, and presentations for conferences and peer-reviewed publication.
</li><li>Support grant development, including proposal writing and coordination of multi-institutional submissions.
</li><li>Manage research protocols, including IRB submissions and ongoing compliance with institutional and regulatory standards.
</li><li>Coordinate project activities, stakeholder engagement, and dissemination of research findings.
</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 or master&rsquo;s degree in social sciences, bioethics, law, philosophy, public health, political science, science and technology studies, or a related discipline preferred
</li><li>At least one year of experience in empirical or policy research related to ethics, law, or the social dimensions of biomedical research or clinical practice preferred.
</li><li>Demonstrated competence in social science methodologies, including qualitative and/or quantitative research approaches preferred.
</li><li>Excellent writing, analytical, and organizational skills, with the ability to work both independently and collaboratively to meet deadlines preferred.
</li><li>Strong oral and written communication skills in English preferred.
</li></ul>Desired Qualifications
<ul><li>Advanced degree (master&rsquo;s or doctorate) in bioethics, law, public policy, social sciences, or a related discipline preferred.
</li><li>Experience with mixed-methods research, comparative policy analysis, and/or stakeholder engagement preferred.
</li><li>Prior experience with grant writing and research project coordination.
</li><li>Multilingual proficiency preferred.
</li><li>Experience working in interdisciplinary and cross-cultural research environments preferred.
</li></ul>This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.
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>

ELSi Research Associate

Syneos Health

<div>Description
Pharmacy Technician I &ndash; Clinical Research<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
Job Responsibilities
Do you love being part of a close-knit team that values precision, collaboration, and making a real difference in people&rsquo;s lives? Are you energized by the details that keep clinical research running safely and smoothly? Join our team as a Pharmacy Technician I and be part of an environment where your expertise, reliability, and dedication are recognized and celebrated every day!
Why You&rsquo;ll Love This Role:<ul><li>
Make an impact: You&rsquo;ll play a critical role in preparing, handling, and managing investigational products&mdash;helping ensure that every study runs safely and successfully. The quality of your work directly contributes to advancing medical breakthroughs and improving patient outcomes.</li><li>
Grow your career: Receive hands-on training, strong mentorship, and support as you deepen your skills in the specialized world of clinical research pharmacy. If you&rsquo;re coming from a different environment, we&rsquo;ll help you embrace the learning curve and master this exciting new area.</li><li>
Be part of a small, high-performing team: Work in a collaborative setting where clear communication, trust, and teamwork are essential. Every voice matters, and your contributions will be seen and valued.</li><li>
Enjoy variety and flexibility: No two days are the same! Some days start early, others later&mdash;your schedule may vary based on research study needs. Flexibility and adaptability are key to success here.</li></ul>
What You&rsquo;ll Do:<ul><li>
Manage the receiving, handling, inventory, and dispensing of investigational products.</li><li>
Verify study materials, documentation, and data for accuracy and regulatory compliance.</li><li>
Perform parenteral and aseptic preparation&mdash;including reconstitution, dilution, and non-sterile compounding&mdash;with precision, consistency, and meticulous adherence to aseptic standards.</li><li>
Maintain appropriate storage conditions and supplies to ensure study readiness at all times.</li><li>
Document all processes thoroughly and accurately in compliance with regulatory and clinical standards.</li><li>
Collaborate closely with your teammates and communicate proactively to ensure smooth operations.</li><li>
Participate in audits, data review, and sponsor or regulatory visits.</li><li>
Support equipment maintenance and respond to environmental monitoring alerts as needed.</li><li>
Contribute to training and continuous improvement initiatives within the team.</li></ul>
Where You&rsquo;ll Do It:
Miami, FL &ndash; Downtown: 1951 NW 7th Ave, Miami, FL 33179
Who We&rsquo;re Looking For:<ul><li>
Excellent communicator and team player: You thrive in a small team environment where collaboration, clear communication, and mutual respect are essential.</li><li>
Detail-driven and dependable: You take pride in accuracy, documentation, and compliance&mdash;knowing that every detail matters in clinical research.</li><li>
Flexible and adaptable: You&rsquo;re comfortable with varied start times and understand that clinical studies can require schedule adjustments.</li><li>
Curious learner: You&rsquo;re eager to learn the unique aspects of a clinical research pharmacy and excited to grow your expertise.</li></ul>
What Technical Skills and Experience stand out:<ul><li>
A proven track record with 2+ years of Pharmacy Technician experience.</li><li>
Must be highly experienced in parenteral and aseptic preparation as described above.</li><li>
Certified in the State of Florida by the Board of Pharmacy and able to provide proof of license upon onboarding.</li><li>
National certification, such as from the Pharmacy Technician Certification Board (PTCB), is not required but highly preferred.</li><li>
Proficient with Microsoft Word and Excel; able to manage documentation accurately and efficiently.</li><li>
Experience in clinical research or a regulatory setting is a huge plus!</li></ul>
Why You&rsquo;ll Thrive Here:<ul><li>
Supportive leadership that values teamwork, mentorship, and professional growth.</li><li>
A collaborative, small-team culture focused on precision, learning, and care.</li><li>
The opportunity to make a tangible difference in the success of every study and the lives of participants.</li><li>
A workplace where your expertise is respected, your ideas are heard, and your work truly matters.</li></ul>
Join us and be part of a team that blends scientific excellence with care, energy, and opportunity!
Apply today and help us advance the future of clinical research&mdash;one detail at a time.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Pharmacy Technician I – Clinical Research

Explore 443+ Clinical research coordinator 1 a in Miami this March. Find roles across top companies and apply now to boost your career.