Job Description

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at the UHealth Medical Campus in Miami, FL.

CORE JOB SUMMARY
The Clinical Research Coordinator 1 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 JOB FUNCTIONS
1. Performs chart review/pre-screening activities for study participant eligibility and coordination of simple
clinical research protocols. Maintains enrollment procedures according to the protocol.
2. Coordinates routine activities of clinical studies including data collection and maintenance, planning study
timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
3. Performs moderate to complex research tests/ experiments and adapts procedures for quality
improvement under supervision.
4. Understands and follows technical instructions for operating clinical research equipment, problem solves
when operational failures occur.
5. Assists in observing and informing the PI/supervisor of adverse events, including those reported by study
participants.
6. Addresses adverse events per protocol, advocating for study participants and quality standards
throughout the lifespan of the study.
7. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
8. Follows the appropriate fundamental requirements of all international, national, and local regulatory
bodies.
9. Knows the contents and maintenance of study-specific clinical research regulatory binders.
10. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research,
continuing education, and research competencies.
11. Adheres to University and unit-level policies and procedures and safeguards University assets.

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’s degree in relevant field

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 SPECIFICS

JOB SUMMARY:

Clinical Research Coordinator,  under the supervision of the Principal Investigator and Clinical Manager, will assist in creating, updating, and maintaining the research charts and case report forms, including regulatory related issues, in accordance with the Clinical Research Services Department Standard Operating procedures (SOP’s).   The incumbent will assist the PI in obtaining informed consent and document the informed consent process as required. He or she is also responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, Standard Operating Procedures, and all applicable regulations and guidelines. This position is responsible for ensuring that effective data flow associated with research protocols are in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.

J OB DUTIES & RESPONSIBLITIES:

• Assists the Monitors, Clinical research Coordinators and PIs in the organization and preparation of Site Initiation Visits (SIV).
• Attend site disease group tumor board meetings and site disease group collaborative meetings usually composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff.
• Assist the Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.
• Assists PI in obtaining informed consent and documents the informed consent process as required.  Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment.
• Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures.  Complete sand submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.
• Assist in the completion of protocol specific documents.  Obtain relevant medical information from patient clinic charts/medical records.  Maintain logs/progress reports to track both currently enrolled as well as follow-up participants.  Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.
• Under the supervision of the Principal Investigator.  Determine data to be collected and develop forms for collecting/summarizing data.  Enter data onto case report forms and/or into computer database as appropriate.  Complete corrections/queries required at audits/monitor visits.  Ensure data integrity and consistency in computer database and written records.
• Assist the Clinical Study Coordinator for the entry of and maintenance of the patient calendar.  Ensure protocol specific data is entered into Velos.
• Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.
• Query data inconsistencies and revise case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.
• Actively participates in monitoring visits/site audits, etc.  Seek review and approval of the Principal Investigator.
• Assist the Clinical Study Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
• Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.
• Provides support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies.
• 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.
• Engage in continuing education of research policies/guidelines.  Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in field of expertise.
• Other duties as assigned.

EDUCATION & EXPERIENCE:

BS degree in science, health care, or related field required.  Must be able to work independently and collaborate with a team, must have experience in clinical settings, hospitals, etc. or prior experience in research. Excellent organizational skills and attention to detail required. Computer skills required.   Microsoft Office skills (Outlook email, Word, Excel, Power Point) required.   Excellent skills in English (both verbal and written) required.

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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

A8

Job Tags

Full time, Temporary work, Local area, Worldwide, Night shift, Weekend work, Afternoon shift,

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