clinical research coordinator 2

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clinical research data specialist

clinical research coordinator 1

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 University of Miami UHealth Department of Urology has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work on-site at Desai Sethi Medical Center in Miami. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.
CORE JOB FUNCTIONS
<ul><li>Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
</li><li>Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
</li><li>Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
</li><li>Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
</li><li>Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
</li><li>Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
</li><li>Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Knows the contents and maintenance of study-specific clinical research regulatory binders.
</li><li>Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets.
</li></ul>Department Specific Functions
Clinical Research Coordinator 1 FTE would be delegated to support Dr. Nima Sharifi&rsquo;s clinical studies. Project-specific duties would include:
<ul><li>Performs screening/recruitment, obtains informed consent process and completes eligibility verification for applicable studies.
</li><li>Establishes and maintains communication with study participants, inter- and intra- departmental study team members, health care providers, sponsors and regulatory entities.
</li><li>Ensures study protocol adherence, including completion of protocol specific procedures and documentation.
</li><li>Maintains screening, enrollment, deviation, delegation of authority and other sponsor and/or protocol specific logs.
</li><li>Enters data onto case report forms and electronic data capture systems in accordance with ALCOA-C+ principles.
</li><li>Collects, processes, ships and tracks biological specimens following study protocol and regulatory guidelines.
</li><li>Reviews consent forms, sample collection tracking forms and clinical data to ensure quality and accuracy.
</li><li>Addresses data inconsistencies and provides responses to queries in a timely manner.
</li><li>Maintains inventory of study supplies and procures collection kits/supplies in anticipation of future needs.
</li><li>Attends research meetings with investigators, study team and site disease group; participates in scientific and clinical discussions relevant to the studies supported.
</li></ul>This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Bachelor&rsquo;s degree in relevant field required
Certification and Licensing:
CCRC, CCRP, or CCRA preferred, but not required
Experience:
Minimum 1 year of relevant experience
Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li><li>Ability to work independently and/or in a collaborative environment.
</li></ul>The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Full time
Employee Type:
Staff</div>

Clinical Research Coordinator 1

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

Clinical Research Coordinator 2

<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 Otolaryngology is currently seeking a full time Clinical Research Coordinator 2 to work on-site in Miami, FL.
CORE JOB FUNCTIONS
<ul><li>Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
</li><li>Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
</li><li>Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
</li><li>Maintains study binders and filings according to protocol requirements, UM and department policy.
</li><li>Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
</li><li>Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
</li><li>Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
</li><li>Assists with study orientation and protocol related in-services to research team and clinical staff.
</li><li>Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule. 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
Serve as the primary Clinical Research Coordinator for the Pediatric Hearing Loss Outcomes &amp; Interventions Lab , providing direct research support to the Principal Investigator, Dr. Ivette Cejas. Provide research coordination support to other Audiology Division investigators conducting pediatric hearing loss or implant-related research, as needed.
<ul><li>Coordinate study activities including participant recruitment, scheduling, consent/assent, and communication with families in accordance with IRB-approved protocols.
</li><li>Perform REDCap development, data entry, management, and quality control , ensuring accuracy and completeness of research data.
</li><li>Assist with data management and analysis to support preparation of presentations, abstracts, and manuscripts.
</li><li>Support grant applications, regulatory submissions, and publication preparation , including tracking deadlines and formatting materials.
</li><li>Collaborate with Children&rsquo;s Hearing Program faculty and staff to integrate research activities within clinical settings.
</li><li>Maintain regulatory compliance, including IRB submissions, continuing reviews, and study documentation.
</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 2 years of relevant experience
Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values. Ability to work independently and/or in a collaborative environment.
</li><li>Bilingual preferred
</li><li>Strong communication skills. Ability to interact effectively, compassionately, and professionally with children and their families from diverse cultural, linguistic, and socioeconomic backgrounds.
</li><li>Ability to collaborate with families and clinical teams to support scheduling, follow-up, and adherence to research protocols.
</li></ul>#ED-LI1
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>

ICON plc

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

Clinical Research Associate, Sponsor Dedicated

<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 Part-Time Clinical Research Data Specialist to work onsite in Miami. 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>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
 
Education:
 
High School Diploma or equivalent/relevant experience, certification or license
 
 
Experience:
 
No previous experience required
 
 
Knowledge, Skills and Abilities:
<ul><li>Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
</li><li>Teamwork: Ability to work collaboratively with others and contribute to a team environment.
</li><li>Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
</li><li>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
</li></ul>Department Specific Functions
<ul><li>Adheres to all UM and department policies and procedures.
</li><li>Assists multidisciplinary team in research activities.
</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>Adheres to University and unit-level policies and procedures and safeguards University assets. 
<li>
</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:
Part time
Employee Type:
Temporary</div>

Clinical Research Data Specialist

Evolution Research Group

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

Assistant Lab Manager

Jackson Health System

<div>Organ Placement Clinical Coordinator, Transplant Donor Desk, Full Time, Nights 12 hour Shift
Jackson's Miami Transplant Institute
Department: Miami Transplant Institute (MTI)- Transplant Donor Desk
Address: 1801 NW 9th Avenue, Miami, Florida 33136
Shift Details: Full Time, Nights 12 hour shift
***Certified surgical technologist or foreign trained physician highly preferred and OR experience Highly preferred**
Why Jackson's Miami Transplant Institute:
The Miami Transplant Institute is the only center in Florida that performs all types of organ transplantsheart, lung, heart-lung, kidney, pancreas, kidney-pancreas, liver, intestinal, and multi-visceral transplants. Since opening in 1970, the Miami Transplant Institute has been dedicated to offering patients the best possible surgical, medical, and rehabilitation care. Miami Transplant Institute has been doing liver transplants for almost 50 years with more than 4,000 livers since 1988. We perform more than 125 liver transplants a year, one of the highest volumes in the country. Most importantly, our programs for both children and adults consistently rank among the nation's best in terms of patient outcomes.
Job Summary 
The Transplant Organ Placement and Preservation Coordinator is a professional trained in the evaluation of deceased donor organ offers, waitlist review and patient selection, donor-recipient matching, and all aspects of the coordination, planning, and follow-up on organ offers, procurement, and transplantation procedures. Also provides organ preservation support to surgeons during organ procurements outside of local donation service area (DSA). Ability to apply knowledge of the United Network for Organ Sharing (UNOS)/ Organ Procurement and Transplantation Network (OPTN), the Centers for Medicare and Medicaid Services (CMS) Condition of Participation (CoP) for Transplant Programs, and the Joint Commission governing organ donation and transplantation in the U.S. is required to ensure hospital and transplant program adherence to all regulations. 
 
Duties and Responsibilities: 
<ul><li>Receives all organ offers through the OPTN/UNOS Donor Net Online Portal.</li><li>
Requires disposition of organ offer to include an acceptance or turn down with refusal codes within 30 minutes of electronic offer.</li><li>
Reviews and interprets the organ match run to identify the appropriate FLJM recipients, identify when to select recipients from local versus national match-run, identify when offer must by-pass FLJM or when FLJM has secured local back-up.</li><li>
Understands and communicates effectively waiver information on each import organ, understanding the type of waiver and implications for payment of the organ. Presents critical aspects of the organ offers to the Transplant Surgeon focusing on donor history, hospital course, medications and major treatment interventions, laboratory review including serology, and blood type.</li><li>
Requires clarifying communication between the offering Organ Procurement Organization (OPO) and the OPTN to obtain complete clinical, psychosocial, infectious disease, laboratory, and logistical information on the organ donor and specific organ offer.</li><li>
Provides advance patient selection assistance to the transplant surgeon and assists in reviewing, screening, selecting, and recommending transplant candidates based on organ specific criteria.</li><li>
Coordinates the transplant event process which includes: patient hospital admission set up, clinical team notification to include surgery, OR, on-call resident, ICU Team, Blood Bank, transplant histology lab, Infectious Disease, etc.</li><li>
Coordinates start times of organ recovery and organ transplant.</li><li>
Detailed documentation of all communications and decisions are required on a case worksheet.</li><li>
Coordinates the recovery of the organ to include transportation logistics (ground and air), timing, and retrieval team selection including Surgeon, Preservationist, and Fellow.</li><li>
Provides guidance to the transplant team on donor-recipient matching criteria such as infectious disease screening, and other factors critical to the patient pre and peri-operative care plan.</li><li>
May also update Model of End Stage Liver Disease (MELD) scores, Lung Allocation Scores (LAS), heart, kidney, or other organ priority status online in UNet at the direction of the Transplant Coordinator/transplant physician.</li><li>
Attends the organ specific listing committee and / or waitlist management meeting to better familiarize themselves with patients toward the top of the organs transplant lists that will be presented with an organ offer.</li><li>
Reviews and distributes deceased donor cultures to the appropriate clinical care teams.</li><li>
Receive and triage all pre and post-transplant patient calls after hours, in consultation with Transplant Organ Placement Clinical Specialist (RN).</li><li>
Uses the OTTR database and MIRACLE as appropriate to document organ offers and acceptances.</li><li>
Insures pertinent data from transplant event are recorded accurately in the database.</li><li>
Responsible for coordinating the procurement surgical staff with the clinical recovery, preservation and transportation of organs to be used in clinical transplantation. Coordinates staff in the operating room for non-local procurements with clinical recovery and preservation of organs for transplantation, and undertakes extensive communications with transplant center, according to established guidelines Assesses organ function under preservation and preservation parameters and provides data to surgeon.</li><li>
Provides medical / technical assistance to the excising surgeon in the removal of organs and tissues.</li><li>
This assistance consists of exposure, hemostasis, and perfusion of the organs as they are procured.</li><li>
In addition, provides clinical guidance on organ preservation characteristics in terms of flush amounts, medicinal additives, to help ensure optimization of organ function in recipients.</li><li>
Retrieves blood / tissue specimens necessary for tissue typing and ensures timely delivery to the appropriate laboratory.</li><li>
Assists host OPO in the packaging of the organ(s) and transports according to protocol to recipient facility.</li><li>
This includes the retrieval of organs from the airport and transporting them to the operating room for cases that the organ is procured by a local surgeon and sent to JMH.</li><li>
Assists in the maintenance of preservation / perfusion laboratory including the maintenance of an adequate inventory and availability of all supplies and medications. Responsible and accountable for assigned procurement equipment and supplies.</li><li>
Participates in quality assessment and performance improvement activities including but not limited to data entry, data abstraction, data analysis, report compilation, QAPI Committee presentations, participation in improvement teams, and waitlist management.</li><li>
Accepts special project assignments related to transplant patient care, patient safety, data analysis, and quality improvement.</li><li>
Demonstrates behaviors of service excellence and CARE values (Compassion, Accountability, Respect and Expertise).</li><li>
Other duties as assigned.</li></ul>
Experience<ul><li>
Generally requires 1 to 3 years of related experience.</li><li>
OR experience is preferred.</li><li>
Experience as surgical recovery coordinator in OPO setting preferred.</li></ul>
Education<ul><li>
Associate's degree in related field is required.</li><li>
Certified surgical technologist or foreign trained physician highly preferred.</li></ul>
Skill 
<ul><li>Ability to analyze, organize and prioritize work accurately while meeting multiple deadlines.</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 understand and follow instructions.</li><li>
Ability to exercise sound and independent judgment Knowledge and skill in use of job appropriate technology and software applications.</li></ul>
Credentials 
<ul><li>Certified Transplant Preservationist (CTP) is preferred.</li><li>
American Heart Association Basic Life Support (BLS) and any additional applicable life support certification for Healthcare Providers is required upon hire with at least 6 months validity and maintenance at JHS for the duration of employment.</li></ul>
Unit Specific Credential<ul><li>
Basic Life Support (BLS)</li></ul></div>

Organ Placement Clinical Coordinator, Transplant Donor Desk, Full Time, Nights 12 hour Shift

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Organ Placement Clinical Coordinator, Transplant Donor Desk, Full Time, Nights 12 hour Shift