Clinical Research Coordinator

Clinical Research Coordinator 1 page is loaded## Clinical Research Coordinator 1remote type:
On-Site locations:
Miami, FL:
Coral Gables, FLtime type:
Full time posted on:
Posted Todayjob requisition : R
** 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, please review this .The Clinical Translational Research Site is currently seeking a full time Clinical Research Coordinator 1 to work in Miami.
** CORE

JOB SUMMARY:

** 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.
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* CORE RESPONSIBILITIES:

*** Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
* Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
* Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
* Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
* Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
* Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
* Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
* Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
* Knows the contents and maintenance of study-specific clinical research regulatory binders.
* Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
* Adheres to University and unit-level policies and procedures and safeguards University assets.
** CORE

QUALIFICATIONS:

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* Education:

** Bachelor's degree in relevant field
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* Experience:

** Minimum 1 year of relevant experience
** Knowledge, Skills and Attitudes:
*** Skill in completing assignments accurately and with attention to detail.
* Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
* Ability to process and handle confidential information with discretion.
* Ability to work evenings, nights, and weekends as necessary.
* Commitment to the University's core values.
* Ability to work independently and/or in a collaborative environment.
** Department Specific Functions
** 1. Conducts or supports the informed consent process only after training,competency validation, and delegation; ensures current IRB-approved documents are used and filed.
2. Collects, enters, verifies, and maintains study data in approved systems; completes source documents and CRFs/eCRFs and responds to routine queries.
3. Communicates routine study updates, scheduling needs, missing documentation,and risks to the PI, supervisor, and study team.
4. Prepares and routes routine IRB submissions, amendments, continuing reviews,closures, and supporting documents under supervision.
5. Collects and maintains CVs, licenses, training…