Jobs
>
Hialeah

    Clinical Research Coordinator - Hialeah, United States - Evolution Research Group

    Default job background
    Description
    Job DetailsJob LocationLOC003
    CPMI Clinical Pharmacology Miami - Hialeah, FLCRCTitle:

    Clinical Research Coordinator Location:

    CPMI

    About us:
    ERG is a leading U.S.

    based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development.

    With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies.

    ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine.

    With access to over 32 million patients/subjects and completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.


    Job Description:
    The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials.

    The CRC 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:


    GeneralObtain 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.

    Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.

    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.

    Manage studies with direct oversight from Site Director, and Principal Investigator to ensure compliance with protocol requirements.
    Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment. Contribute to the SOP review and development as delegated by the Site Director. Study Management Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
    Attend the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.

    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.

    Screen, enroll subjects and schedule subject visits in conjunction with Principal InvestigatorReview and obtain informed consent from with potential study volunteerDocument all written and phone correspondences with sponsor, labs, IRB other regulatory organizationsMaintain organized, accurate and complete study recordsAssist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.

    Enter data as appropriate for protocol (paper-electronic data capture)In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.

    Perform study close-out procedures.

    Store study records appropriatelyAdditionally, 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's objectives.


    Skills and Qualifications:
    Education and experienceHigh School Diploma or its equivalent; College degree preferred.
    Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology to communicate with physician office and laboratory staff.

    Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.

    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.

    RequirementsUnderstand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines. Excellent communication skills (interpersonal, written, verbal) Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)


  • Inspire Staffing Hialeah, United States

    Job Description · Job DescriptionThe Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC will complete all study-related procedures and distribute study medications and instr ...


  • Superior Associates in Research Hialeah, United States

    Job Description · Job DescriptionDescription:Job Summary: · The Clinical Research Coordinator will be responsible for managing clinical research studies, including recruiting and screening patients, coordinating study visits and procedures, maintaining study records, and ensuring ...


  • Nicklaus Children's Hospital Doral, United States Full time

    Description · Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writi ...


  • Miami Children's Hospital Doral, United States Full time

    Job Description - Clinical Research Coordinator (Full Time, Day shift · Job Description · Clinical Research Coordinator (Full Time, Day shift) · - · 26385 · Description · Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment ...


  • Miami Children's Doral, United States Full time

    Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and corresp ...


  • Nicklaushealth Doral, United States Full time

    · Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and corr ...


  • Flourish Research Doral, United States

    Job Description · Job Description · Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives · We offer an excellent comprehensive benefits package, a supportive and ...


  • Clinical Trials Investment Group Doral, United States

    Job Description · Job Description · Clinical Research Site seeking full time clinical research coordinator with experience. Must be Bilingual. · Responsibilities: · Must be able to manage an coordinate accordingly · Must provide clinical research support to investigators to pre ...


  • Nicklaus Children's Health System Doral, United States Full time

    · Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and cor ...


  • Nicklaus Children's Hospital Doral, United States Full time

    · Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and corr ...


  • System One Holdings, LLC Doral, United States

    Job Title: Cardiology Clinical Research Coordinator · Location: · Miami, FL · Hours/Schedule: · Monday-Friday; 8am - 5pm · Type: · Onsite · Joule is currently looking for a Clinical Research Coordinator to work with one of our largest clients.The candidate must be bilingual:E ...


  • System One Doral, United States

    Job Title: · Clinical Research Coordinator · Location: Miami, FL · Hours/Schedule: Monday-Friday; 8am - 5pm · Type: Onsite · Joule is currently looking for a Clinical Research Coordinator to work with one of our largest clients. The candidate must be bilingual: English/Spanish ...


  • Clinical Trials Investment Group Miami, United States

    Job Description · Job DescriptionClinical Research Site seeking full time clinical research coordinator with experience. Must be Bilingual. · Responsibilities: · Must be able to manage an coordinate accordingly · Must provide clinical research support to investigators to prepare ...


  • Flourish Research Miami, United States

    Job Description · Job DescriptionFlourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives We offer an excellent comprehensive benefits package, a supportive and collabo ...


  • COLUMBUS CLINICAL SERVICES LLC Miami, United States

    Job Description · Job DescriptionColumbus Clinical Services is looking for experienced Clinical Research Coordinators (CRC) for their fast-paced, high-energy, clinical research site. · Availability morning, evenings and weekends. CRCs may work up to 40 hours a week · Proficient w ...


  • SQRL Miami, United States

    Job Description · Job DescriptionOpportunity to join one of the fastest-growing Clinical Research site networks in the US The Kendall (Miami) site started in respiratory and sleep trials but has since expanded into neuroscience and infectious disease studies. Join a site that pri ...


  • University of Miami Miami, United States Full time

    Current Employees: · If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review th ...


  • Nicklaus Children's Health System Miami, United States OTHER

    Job Summary · Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and corresp ...


  • Phoenix Clinical Research, LLC. Tamarac, United States

    Job Description · Job DescriptionClinical Research Coordinator · About us · Phoenix Clinical Research is a small business in HEALTH_CARE_MEDICAL in Tamarac, FL We are agile and innovative. · Clinical Research Coordinator · The Clinical Research Coordinator participates in all asp ...


  • Medical Center PA Coral Gables, United States

    Job Description · Job Description · JOB SUMMARY: · The primary responsibility of the clinical research coordinator is to manage the clinical aspects of conducting clinical research trials and the staff working in the designated assigned areas. The clinical research coordinator ...