clinical research coordinator (crc)-ft Jobs in Miami

clinical research coordinator (crc)-ft

case management program manager Jobs in Miami

case management program manager

case manager

clinical research coordinator 1 Jobs in Miami

clinical research coordinator 1

clinical research coordinator 2 Jobs in Miami

clinical research coordinator 2

clinical trial coordinator

Evolution Research Group

<div>About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
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 Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
Responsibilities:
General<ul><li>
Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.</li><li>
Develop draft source documents and review the documents for accuracy and clarity prior to study start up.</li><li>
Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.</li><li>
Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.</li><li>
Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.</li><li>
Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.</li><li>
Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.</li><li>
Contribute to the SOP review and development as delegated by the Site Director.</li></ul>
Study Management<ul><li>
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.</li><li>
Attend the investigator meeting for each assigned protocol, as appropriate.</li><li>
Completion of IRB study renewals and maintain copies of all IRB communications.</li><li>
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.</li><li>
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator</li><li>
Review and obtain informed consent from potential study volunteers.</li><li>
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.</li><li>
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.</li><li>
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.</li><li>
Outcome of enrollment and sponsor monitoring visits of all assigned protocols</li><li>
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.</li></ul>
Skills and Qualifications:<ul><li>
Education and experience<ul><li>
High School Diploma or its equivalent; College degree preferred.</li><li>
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator</li><li>
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.</li><li>
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.</li><li>
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.</li><li>
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.</li></ul></li><li>
Requirements<ul><li>
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.</li><li>
Excellent communication skills (interpersonal, written, verbal)</li><li>
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)</li></ul></li></ul></div>

Clinical Research Coordinator (CRC)-FT

<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.
 
 
 
 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 Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
 
 
 
 Responsibilities
 
 
 
 
 General
 
 
 
 <ul>
 <li>
 Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
 </li>
 <li>
 Develop draft source documents and review the documents for accuracy and clarity prior to study start up.
 </li>
 <li>
 Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.
 </li>
 <li>
 Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
 </li>
 <li>
 Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.
 </li>
 <li>
 Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
 </li>
 <li>
 Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.
 </li>
 <li>
 Contribute to the SOP review and development as delegated by the Site Director.
 
 
 </li>
 </ul>
 
 Study Management
 
 
 
 <ul>
 <li>
 Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
 </li>
 <li>
 Attend the investigator meeting for each assigned protocol, as appropriate.
 </li>
 <li>
 Completion of IRB study renewals and maintain copies of all IRB communications.
 </li>
 <li>
 In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
 </li>
 <li>
 Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
 </li>
 <li>
 Review and obtain informed consent from potential study volunteers.
 </li>
 <li>
 Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
 </li>
 <li>
 Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.
 </li>
 <li>
 Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
 </li>
 <li>
 Ensure timely and accurate CRF completion for each study subject.
 </li>
 <li>
 In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
 </li>
 <li>
 Outcome of enrollment and sponsor monitoring visits of all assigned protocols
 </li>
 <li>
 Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.
 
 
 </li>
 </ul>
 
 Skills And Qualifications
 
 
 
 <ul>
 <li>
 Education and experience
 </li>
 <ul>
 <li>
 High School Diploma or its equivalent; College degree preferred.
 </li>
 <li>
 Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator
 </li>
 <li>
 Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
 </li>
 <li>
 Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.
 </li>
 <li>
 Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
 </li>
 <li>
 Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
 </li>
 </ul>
 <li>
 Requirements
 </li>
 <ul>
 <li>
 Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
 </li>
 <li>
 Excellent communication skills (interpersonal, written, verbal)
 </li>
 <li>
 Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
 </li>
 </ul>
 </ul>
</div>

Doctors Research Network

Organization: Doctors Research Network<ul><li>Sponsor interactions, and study team communications.</li><li>Quality Assurance: Proactively identify and resolve study-related issues; maintain compliance with SOPs, FDA, GCP, and HIPAA standards.</li><li>Fluency in Spanish is required</li></ul>About Doctors Research NetworkDoctors Research Network is a leading clinical research organization committed to advancing science and improving patient outcomes through high-quality, ethical, and efficient clinical trials. Our network partners with top physicians, sponsors, and CROs to deliver cutting-edge research across a wide spectrum of therapeutic areas. We are seeking a highly skilled Senior Clinical Research Coordinator (CRC) to join our Miami team and help drive the success of our expanding research portfolio.Position OverviewThe Senior Clinical Research Coordinator will play a pivotal role in the planning, execution, and oversight of clinical trials, ensuring compliance with FDA regulations, GCP/ICH guidelines, IRB requirements, and study protocols. This individual will serve as a subject matter expert, mentor junior staff, and act as the primary liaison between investigators, sponsors, CROs, and patients.Key Responsibilities<ul><li>Protocol Management: Coordinate and manage all aspects of assigned clinical trials from start-up through closeout, ensuring strict adherence to protocol requirements.</li><li>Regulatory Compliance: Prepare, submit, and maintain IRB/EC submissions, regulatory documents, and essential study files.</li><li>Participant Oversight: Screen, consent, and enroll eligible participants; schedule visits; conduct study assessments; and maintain accurate source documentation.</li><li>Data Integrity: Ensure timely, complete, and accurate data entry into EDC systems; respond to queries promptly; and participate in data audits/monitoring visits.</li><li>Site Leadership: Serve as lead coordinator on complex studies; mentor and train CRCs, research assistants, and support staff.</li><li>Collaboration: Act as primary contact with sponsors and CROs; coordinate site visits, monitor.</li><li>Operational Efficiency: Assist with budgeting, study feasibility assessments, and resource allocation to optimize site performance.</li></ul>Qualifications<ul><li>Bachelor&rsquo;s degree in life sciences, nursing, or a related field required; advanced degree or RN preferred.</li><li>Minimum 3 years of clinical research coordination experience (multi-site or multi-therapeutic area preferred).</li><li>Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.</li><li>Experience with EDC systems, CTMS, and eRegulatory platforms.</li><li>Excellent organizational skills with the ability to manage multiple trials simultaneously.</li><li>Proven track record of mentoring junior staff and leading site-level operations.</li><li>Exceptional interpersonal skills to engage patients, investigators, and sponsor/CRO partners effectively.</li><li>Bilingual (English/Spanish) a MUST.</li></ul>Why Join Us<ul><li>Opportunity to work on innovative, high-impact clinical trials with leading physicians and sponsors.</li><li>Collaborative and mission-driven environment focused on quality and patient care.</li><li>Competitive compensation.</li><li>Career advancement within a growing clinical research network.</li></ul>Job Type: Full-timePay: $24.00 - $30.00 per hourBenefits:<ul><li>Paid time off</li><li>Professional development assistance</li></ul>Experience:<ul><li>Clinical research: 3 years (Preferred)</li></ul>Language:<ul><li>Both English and Spanish (Required)</li></ul>License/Certification:<ul><li>Current GCP, IATA, Phlebotomy certification (Preferred)</li></ul>Work Location: In person

Senior Clinical Research Coordinator

University of Miami

<div>Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet .
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

<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 APRN Team Manager functions as a clinical leader and clinical team member delivering care to a panel of patients for whom s/he has responsibility for the planning, implementation, coordination, and evaluation of care related outcomes. As a clinical leader the APRN Team Manager is responsible for the management and oversight for the clinical practice of the inter-professional team which may include nurses, medical assistants, and others who are integral to the care of patients at the site. Works in partnership with the patient care team and other practice leaders to ensure effective delivery of care and actively supports the achievement of patient, departmental and organizational goals.
CORE JOB FUNCTIONS
<ul><li>Develops, leads and manages the clinical practice, quality and safety of patient care of an interdisciplinary team which may include registered nurses, licensed practical nurses, medical assistants and others who are essential to the care delivery model.
</li><li>Coordinates care and meeting patient care needs in conjunction with a variety of providers including licensed independent providers acting in consultation, population managers, care managers, and others. Participates in the hiring, supervision, and performance evaluation for team members.
</li><li>Identifies opportunities for and initiates interdisciplinary collaboration to achieve team and patient goals.
</li><li>Utilizes available resources and methodologies to advance practice within the department and beyond, with the aim of improving the care of all patients, particularly those most at risk for adverse outcomes.
</li><li>Seeks opportunities to disseminate clinical knowledge and nursing practice development through publication in scholarly journals and participation in professional meetings.
</li><li>Leads and/or participates in departmental, hospital and/or system-level committees and task forces as a representative of the department, practice and the Department of Nursing as requested.
</li><li>Collaborates with physicians, physician assistants and the interdisciplinary team to refine team goals and objectives and further ensures ongoing continuous improvements to the care delivery model. Analyzes, interprets and presents team-based care results to various audiences as appropriate including senior organizational leaders, departmental and practice leaders, nursing leadership, colleagues, and staff.
</li><li>Collaborates with the other members of the team, appreciating and valuing their contributions, and encouraging all to &ldquo;work at the top of his/her license/role, education and training&rdquo; for effective care and service to patients in the context of efficient use of resources.
</li><li>Establishes effective interpersonal relationships with other nurses, clinical departments, and interdisciplinary colleagues.
</li><li>Provides direct care, counseling, and teaching to patients. Performs physical examinations and provides preventive health measures appropriate to patient needs.
</li><li>Orders, interprets, and evaluates appropriate lab and diagnostic tests to assess patients&rsquo; clinical problems and health care needs. Arranges for appropriate plan of care and follow-up based on outcome of diagnostic, lab, and physical assessment findings.
</li><li>Sets priorities for appropriate and efficient management of patient care that reflects evidence-based practice and cost-effective management of time, available human resources, supplies and equipment.
</li><li>Incorporates the concepts of health maintenance, prevention, and promotion into daily practice through patient education and counseling. Assists patients and families in self-care management through the provision of information, tools and resources.
</li><li>Engages in regular performance improvement activities. Uses performance and patient outcome data for continuous quality improvement. Contributes to developing structure, processes and systems to improve the care and disease management of patients.
</li><li>Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
</li></ul><div>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>Graduate of master&rsquo;s in science in Nursing with approved APRN Curriculum or higher.
</li><li>Florida Licensure as A PRN from Florida Board of Nursing.
</li><li>Board Certification as A PRN from nationally accredited organization such as American Nurses Credentialing
</li><li>Center (ANCC) or American Academy of Nurse Practitioner (AANP).
</li><li>Current Certification in BLS and ACLS
</li><li>C TI certification within three months of employment
</li><li>Advanced Oncology Nurse Practitioner Certification (AOCNP) within one year of employment 
</li></ul> 
Experience:
<ul><li>Minimum of 3 - 5 years of relevant experience 
</li></ul> 
Knowledge, Skills and Attitudes:
<ul><li>Ability to handle difficult and stressful situations with professional composure.
</li><li>Ability to maintain effective interpersonal relationships.
</li><li>Ability to analyze, consolidate, and interpret accounting data.
</li><li>Ability to compile, organize, interpret, and communicate accounting data and results concisely.
</li><li>Ability to manage a budget and work within the constraints of that budget.
</li></ul>Department Specific Functions
Direct Oversite of the following Departments and Programs
Phase I/ET clinic and staff
<ul><li>Oversight of the phase I/ET clinic that aligns with the goals for NCI designation.
</li><li>Oversight of Phase I APPs and Nurse Manager, nursing staff, and clinical operations.
</li><li>Provide continual QI of Phase I/ET patient services with real-time rounding surveys.
</li><li>Involve key stakeholders/leaders.
</li><li>Maintain financial and patient satisfaction reports.
</li><li>Assure appropriate clinical coverage and resources for the operations of the clinic.
</li><li>Mentor and develop Nurse Manager.
</li><li>Ensures compliance with regulatory and maintains credentialing, competencies, and professional standards for all APPs and nurses in the clinic.
</li><li>Regularly meet with Phase I/ET staff to assure quality care and to address needs.
</li><li>Assures educational needs of staff are being met.
</li><li>Track metrics related to volume and provide feedback to Executive leadership when resources identified are needed.
</li><li>Act as a liaison between physician leaders, physician investigators (PIs), sub-PIs, departments, and divisions.
</li></ul>Advance Practice Provider oversight to Research APPs
<ul><li>Serves as a mentor and role model to all APPs, thus facilitating the development from novice to expert.
</li><li>Serves as a liaison and advocate between the APP and hospital leadership, department heads, and collaborating physicians.
</li><li>Assist APPs in clinical integration upon hire and throughout time of employment.
</li><li>Identifies APP learning needs and provides learning experiences to meet those needs.
</li><li>Integrates and informs APP of current knowledge of professional issues, trends in health care and technological advances into APPs scope of practice.
</li><li>Teaches/lectures in continuing education programs, journal clubs, conferences, and provides APPs opportunities for learning.
</li><li>Participates in and or coordinates community education programs.
</li><li>Coordinates assignments of preceptors to advanced practice providers. Provides coordination of APP students with university liaisons.
</li><li>Identifies opportunities and challenges to promote full scope of practice in the advanced practice model.
</li></ul></div><div><ul><li>Ensures and coordinates standardization of advanced practice processes between patient care services and collaborative teams.
</li><li>Ensures compliance with regulatory and maintains credentialing, competencies, and professional standards for all APPs in the service line.
</li><li>Provides coordination of coverage during weekdays and weekends between satellites, hospitals, and outpatient areas.
</li><li>Evaluates and approves APPs time-off requests per university policy and procedures.
</li><li>Leads an entity committee and Co-leads collaborative team in developing a new service or strategic performance improvement.
</li><li>Engages and empowers staff by sharing decision-making, delegating, providing choice and fostering autonomy and adaptability.
</li><li>Contributes to the design, development, and implementation of strategic and operational initiatives.
</li><li>Prioritizes competing demands while integrating strategic plan into daily operations.
</li><li>Leads and supports APP staff during periods of transition; communicates purpose and empowers staff to embrace change.
</li><li>Leads staff during the implementation and evaluation of new initiatives at the unit, division and department level.
</li><li>Recruits, hires, and facilitates training and orientation. Manages, recognizes, and rewards performance. Provides ongoing formal and informal performance feedback.
</li><li>Cultivates a climate of professional growth and development to promote excellence, retain talent and develop future leaders.
</li><li>Initiates and/or participates in unit and/or hospital research activities.
</li><li>Utilizes research findings and nursing theory in clinical practice. Promotes evidence-based/knowledge-based nursing practice.
</li><li>Collects data for patient and program evaluation and participates in quality assessment and improvement/patient experience activities.
</li></ul>Administrative Duties
Clinical Operations:
<ul><li>Improve the clinical operations and patient experience by coordinating efforts to deliver a plan of care that addresses the medical, surgical, emotional, physical, educational, short, and long-term needs of individual and family's needs in a setting of expertise, warmth, and compassion.
</li><li>Monitor national &quot;best practices&quot; and integrates into current practice.
</li><li>Examine operational gaps and formulate a plan to close the gaps by defining objectives, implement and track timelines, establish new program roll out to staff and patients while gauging anticipated outcomes and
</li><li>evaluating process.
</li><li>Works collaboratively with SCCC Executive &amp; Nursing Leadership to develop and implement clinic flow parameters, including benchmarks and dashboards for patient flow through their visits, and processes for proactively managing.
</li><li>Cross covers for other APPs or APP Supervisors when needed.
</li><li>Draft Policies and Procedures for new initiatives as needed and update existing policies.
</li><li>Provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.
</li><li>Operates within budget guidelines under the supervision of Executive Leadership.
</li><li>Collaborates with Nursing and system leadership on meeting and maintaining accreditation standards.
</li></ul></div><div>Nurse Practitioner (Clinical &amp; Research) Duties and Responsibilities
Clinical Role/Research
<ul><li>Provides care to a select group of patients by determining and rendering advanced nursing and medical interventions.
</li><li>Assessment/Diagnosis : Assesses patients by interviewing/examining the patient, reviewing the patient&rsquo;s medical history, provider&rsquo;s/physician&rsquo;s/PI/Sub-PI diagnosis and orders, diagnostic test results (labs, x-ray, MRI, etc.) to determine medical diagnosis, plan of care and monitor patient&rsquo;s progress.
</li><li>Reviews the medical record including physician/consultation notes, lab(s) and diagnostic tests results. Formulates medical diagnoses based on the data.
</li><li>Screens for patients for clinical trials based on information collected above.
</li><li>Collaborates with referring physician or physician investigator (PI) through discussion and assessment of diagnoses and ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol.
</li><li>Assesses patients for trial-related and non-trial related symptoms and ensures evidence-based symptom management while maintaining trial compliance.
</li><li>During Phase I/dose escalation studies, collaborates with the principal investigator to determine if dose limiting toxicity has been achieved based on adverse event assessment data and clinical judgement.
</li><li>The APRN will also work with the clinic/triage nurse and physician investigator (PI) to assure timely call back to patient calls regarding any medical or study procedure concerns.
</li></ul>Planning/Outcomes : Develops a plan of care from the assessment/diagnoses and physician/PI/Sub-PI collaboration.
<ul><li>Identifies expected outcomes based on the assessment/diagnoses and physician/PI/sub-PI collaboration.
</li><li>Ensures initial and ongoing consent process is performed and documented in compliance with FDA, Good Clinical Practice (GCP), institutional sponsor, IRB, and other applicable regulations, guidance&rsquo;s, and policies.
</li><li>Participates in the education of clinical trial patients about their clinical trial and significant new information that is forthcoming during or after the conduct of the trial.
</li><li>Ensures ordering and scheduling of all procedures/exams that are required to enroll patients, for further assessment for adverse events, and for evaluation of disease response to study treatment according to protocol.
</li><li>Ensures adherence to protocol schedule of events, study drug, and other requirements.
</li><li>Ensures the successful completion of correlative components of the clinical trial (pharmacokinetics and quality of life studies).
</li><li>Orders, prescribes, and recommends interventions in plan of care that reflects expected outcomes.
</li></ul></div><div>Implementation : Institutes necessary actions as outlines in the plan of care.
Collaborates with research and primary care team members to ensure implementation of plan
<ul><li>Implements physician/PI/Sub-PI orders per protocol.
</li><li>Works in collaboration with study team to assure good documentation clinical practices and assures there is a source related to the documentation being performed.
</li><li>Documents assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and role.
</li><li>Documents adverse events according to CTCAE criteria.
</li><li>Provides patient/family education regarding disease processes, treatment options, treatment outcomes, possible complications, medications, drug handling (oral treatments), discharge/follow-up planning and lifestyle modification.
</li><li>Integrates current knowledge of professional issues, trends in health care and technological advances into scope of practice.
</li><li>Communicates plan of care to team members.
</li><li>Assists in the management of family dynamics and coping mechanisms during acute and chronic phases of patient care.
</li></ul>Evaluation : Evaluates the patient&rsquo;s progress in attaining expected outcomes by follow up with
<ul><li>collaborating physician and staff
</li><li>Evaluates disease response results and physical assessment data in conjunction with the principal investigator or sub investigator to determine response per the protocol.
</li><li>Assures patient is transferred to appropriate physician/specialty once study completed.
</li></ul>Consultation/Collaboration : Consults with collaborating physician(s) on implementation, evaluation and revision of treatment plan.
<ul><li>Ensures ongoing formal and informal communication regarding clinical trials with team members.
</li><li>Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, respect for persons, beneficence, and justice.
</li><li>Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with an accrual to clinical trials.
</li><li>Provides education related to clinical trials to staff, patients, and their significant others.
</li><li>Advocates for clinical trial patients as well for promotion and integrity of the clinical trial.
</li><li>Advocates for clinical trials by participating in community outreach efforts to provide general clinical trials education when opportunities arise.
</li><li>Coordinates care with interdisciplinary health care team in the development and implementation of plan of care.
</li><li>Conducts or participates in multidisciplinary rounds and ensures appropriate and quality care for patients.
</li><li>Attends institutional PI and Site Disease Group (SDG) meetings and participates by providing patient updates required by study team and any potential patients that can be enrolled.
</li></ul></div>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>

APP Team Manager - Medicine, Hematology - Full Time

<div>TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Clinical Research Manager (CRM) - home based in East Coast, US.
If you have a minimum of 5 years clinical operation experience in a CRO setting (plus no less than 1 year of CRM experience) with at least 1+ year of OPH experience and are fluent in Spanish and English - we want to hear from you!
About this role
As part of our CDS Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. 
 
The Clinical Research Manager (CRM) is is part of Clinical Operations Unit within TFS Clinical Development Services and will function operationally as a member of a Project Team being responsible of coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs, and regulatory requirements in addition to financial and contractual obligations.
The CRM will be reporting to the Project Manager being responsible of certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.
Key Responsibilities:<ul><li>
Project oversight and responsibility over clinical operations deliverables</li><li>
Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to the applicable SOPs, protocol requirements, study specific plans, ICH/GCP and all other applicable laws, rules, and regulations.</li><li>
Serve as primary Sponsor contact for operational project-specific issues and study deliverables.</li><li>
Lead, manage and guide CRAs ensuring all necessary project-specific training is provided, carried out, and documented.</li><li>
Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.</li><li>
Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.</li><li>
Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.</li><li>
Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.</li><li>
Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.</li><li>
Perform co-monitoring visits as part of the monitoring team quality oversight.</li><li>
Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.</li><li>
Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.</li><li>
Reviewing protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns.</li><li>
Leading and guiding the internal clinical study team and chairing study team meetings.</li><li>
Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level.</li><li>
Ensure documents remain current during the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager</li></ul>
Qualifications:<ul><li>
Degree in clinical, science or health related field</li><li>
5+ years of clinical research experience, as a CRA, including relevant on-site monitoring experience.</li><li>
Minimum of 5 years clinical operation experience in a CRO setting (plus no less than 1 year of CRM experience) with at least 1+ year of OPH experience - this is mandatory</li><li>
Able to work in a fast-paced environment with changing priorities.</li><li>
Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.</li><li>
In-depth knowledge of applicable clinical research regulatory requirements Good Clinical Practice, ICH guidelines</li><li>
Ability to work independently as well as in a team matrix organization and multiple projects.</li><li>
Excellent English and Spanish written and verbal communication skills as well as computer skills</li><li>
Excellent organizational and leadership skills</li><li>
Ability and willingness to travel up to 20-30%</li></ul>
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You&rsquo;ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.</div>

Clinical Research Manager (CRM) - Spanish Speaker

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APP Team Manager - Medicine, Hematology - Full Time

Clinical Research Manager (CRM) - Spanish Speaker