Clinical Research Coordinator - $46K-65K Per Year

University of Miami is seeking a Clinical Research Coordinator for a job in Miami, Florida.

& Requirements

• Duration: Ongoing
• Shift: 8 hours, days
• Employment Type: Permanent
• Discipline: Allied Health Professional
• Start Date: ASAP
• 40 hours per week
• Specialty: Clinical Research Coordinator

The Sylvester Cancer Center has a great opportunity for a Clinical Research Coordinator 2. 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.

• 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.
• Other duties as assigned.
• 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.
• Provides support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies.
• 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 the Clinical Study Coordinator for the entry of and maintenance of the patient calendar. Ensure protocol specific data is entered into Velos.
• 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.
• 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.
• 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.
• Actively participates in monitoring visits/site audits, etc. Seek review and approval of the Principal Investigator.
• Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.
• Assists the Monitors, Clinical research Coordinators and PIs in the organization and preparation of Site Initiation Visits (SIV).
• 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.
• 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.
• Query data inconsistencies and revise case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.
• Attend site disease group tumor board meetings and site disease group collaborative meetings usually composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff.

Job descriptions are not intended and should not be construed to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job. Management reserves the right to revise duties as needed.

Education

CORE QUALIFICATIONS

Bachelor’s degree in relevant field

Experience

Minimum 2 years of relevant experience

Knowledge, Skills And Attitudes

• Ability to process and handle confidential information with discretion.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Commitment to the University’s core values.
• Ability to work independently and/or in a collaborative environment.
• Ability to work evenings, nights, and weekends as necessary.
• Skill in completing assignments accurately and with attention to detail.

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.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

University of Miami Job ID #R100063022. Pay package is based on 8 hour shifts and 40 hours per week (subject to confirmation).

About University Of Miami

The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common mission of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making the University a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 16,000 faculty and staff from all over the world.

Benefits

• Dental benefits
• 403b retirement plan
• Continuing Education
• Employee assistance programs
• Sick pay
• Wellness and fitness programs
• Vision benefits
• Holiday Pay
• Benefits start day 1
• Medical benefits