Clinical Research Coordinator
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2019-09-09
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The Schiff Center for Liver Diseases is actively seeking a Clinical Research Coordinator. This position requires participation in a cooperative, organized work environment through teamwork, demonstration of a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center, and coverage for other Clinical Research Coordinator (CRC) as needed. This is a full-time regular position with flexible hours (day/night/weekend) to accommodate the need of the study/subject/PI. The incumbent in this position must be willing to travel to investigational meetings. The CRC will conduct all aspects of the clinical trial (outpatient/ inpatient) under the supervision of the Administrator, PI or Director. The CRC manages an assigned set of patients accrued to multiple research protocols to assure efficiency and compliance. The CRC is responsible for screening and enrolling research subjects.
- Initiation Visits (SIV) and in providing the patients and their families with a thorough description of the research protocol. Attends site group collaborative meetings.
- Assures that all continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner. Manage/file all information provided by in-house regulatory team accordingly.
- Compiles patient data and presents those to the PI / recruiter for their determination of patient eligibility for protocol enrollment.
- Assists PI in obtaining informed consent and documents the informed consent process as required. Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures.
- Updates Enrollment log and in-house Study list on a timely manner.
- Replies to emails promptly (same day unless the email is received after business hour)s.
- Complete and submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.
- Ensures study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records.
- Establishes and maintains contact with patients/participants, health care providers, community agencies, study sponsors.
- Updates appropriate agencies such as sponsors, IRB, etc. regarding status of research projects as required and under the supervision of the PI. Maintains /logs progress reports to track both currently enrolled as well as follow-up participants.
- Provides protocol specific study documentation required in the management of study patients as per the protocol, federal regulations, sponsor requirements, SOPs and/or UM policies while maintaining logs to track progress reports participants.
- 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.
- Execute the plan developed for collection of protocol specific subject specimens, i.e. pharmacokinetics samples, blood specimen, tissue samples, etc. as per protocol.
- Ensures that protocol lab kits and study specific supplies are obtained/ordered as necessary. Responsible for the entry of and maintenance of the patient calendars. Ensures protocol specific data is entered into VELOS within 24 hours –Per policy
- Enters EDC and respond to sponsor queries within 24-48 hours
- Monitors adherence to protocol.
- Takes action to report and correct deviations or other problems. Records and reports AEs, SAEs and UPs in compliance with federal regulations, the protocol and UM policies to the sponsor and/or IRB as directed by the PI. Maintains logs including but not limited to the following: screening, enrollment, adverse event, deviation, concomitant medication, delegation and other sponsor and/or protocol specific logs and actively participates in monitoring visits and site audits.
- Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.
- Other duties as assigned.
Knowledge, Skills, and Abilities:
- Basic knowledge base for outpatient clinical care.
- Demonstrates the ability to access relevant clinical information.
- Basic computer skills and proficiency with Microsoft Office; excellent interpersonal, organizational, communication, and time-management skills; and a strong desire to learn.
- Must be able to work independently and collaborate with a team, must have experience conducting quality control audits and data analysis/entry.
- Excellent English (both verbal and written) required.
- Bachelor's degree in Biology or other related field.
- Minimum two years of relevant experience is required.
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 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.
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 timeEmployee Type:StaffPay Grade:r6