Job location: Miami, FL

Employment Type: Full-time
Posted data: 2019-03-22
Req: R100029917
Current Employees:
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Where Excellence Meets Purpose

The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.

With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful purpose to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value.  Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.

The University has been named on Forbes's Best Employers list for two consecutive years, and is the only university in Florida to receive this honor.

The Research Associate 1,  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.

JOB 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 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:

r4