Otolaryngology - Clinical Research Coordinator
University of Miami

Miami, Florida

Posted in Education and Training
about 1 month ago

This job has expired.

Job Info

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Transforming Lives

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 mission 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 Department of Otolaryngology is currently seeking a Clinical Research Coordinator. The incumbent in this position will monitor the proper conduct of the clinical trial (satellite sites and in-house) . Responsible to assure all aspects of protocol are performed as specified and inform the Clinical Research Coordinator of any trials updates/changes in budget, contract, protocol or sponsor requirements. Liaise with Business Development, Analytical Laboratory and Statistical Laboratory effectively to meet project goals. Preparation and review of study-related documentation including but not limited to subject's sources and study specific documents. Development/revision and implementation of Clinical Guidelines for clinical procedures as needed per protocol. Support the preparation of final written clinical report and grant submissions. Communicate, in a timely manner with Principal Investigator, Sub-Investigators and Ethics

Review Boards with respect to subject issues; relay all medical and study related information obtained on patients with regard to their involvement in the trials directly to the Investigator and ensure proper follow-up. Responsible for remaining current with regulatory requirements (TPD, FDA, EMEA, ICH, MHRA, etc.)

Budget and Coverage Analysis development and review for new and current studies. Ensure that protocol lab kits and study specific supplies are obtained as required. Protocol,ICFs and study related documentation submission to IRB as well as continuing reporting, reportable events, amendments and follow ups to IRB. Enter required Report protocol enrollment to CRIS office and JHS according to established procedures. Complete and submit to the CRIS office and/or JHS CTO office protocol forms as required per UM and/or JHS policies. Liaise with Clinical Research Coordinator, when needed, to determine data to be collected and develop forms for collecting/summarizing data. Review data onto case report forms and/or into computer database as appropriate. Assist the Clinical Research Coordinator and Pl in corrections/queries required at audits/monitor visits. Ensure data integrity and consistency in computer database and written reports. Execute the plan developed for procurement of protocol specific subject specimens, pharmacokinetics, and tissue procurement as necessary and ensure it is successfully completed.

Monitor participant adherence to protocol. Take action to report and correct deviations or other problems. Verify accuracy of research data and monitor data quality control. Monitor the proper record of serious adverse events, etc. in compliance with applicable regulations and report to Quality Assurance.

Promptly reports side effects of treatment to the Investigator. In turn, ensures appropriate patient follow up is performed and follow up safety reports are completed and provided to IRB per HSRO policies, protocol specific requirements, GCP, and the federal regulations. Liaise with Clinical Research Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs. Ensure that randomization and registration of patients entered onto Cancer Center sponsored clinical trials are performed in compliance with CRS and UM policies, the protocol,GCP, and federal regulations. Establish/maintain contact with patients/participants, health care provides, community agencies, study sponsors. Update appropriate agencies (such as sponsors,regulatory, etc.) regarding current status of research projects. Liaise with Clinical Research Coordinator to ensure study protocol adherence, including completion of protocol specific procedures and 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. Update Business Office staff as requested about patient accruals/completed cycles for billing of Industry Studies/Federal Studies and for calculation of RVUs for in-house studies. Provide support in relation to the performing of study related procedures as required. i.e. obtain participant's Gift Card and snacks, maintain petty cash accounts, laboratory and tumor assessment studies, prior approval from Director.

Other duties as assigned

The minimum qualifications for this position are as follows: Bachelors' degree required, Master's degree or foreign MD degree preferred. Certified Clinical Research Coordinator/CCRC via ACRP and/or SOCRA preferred. Three years work related experience in Clinical Research required. Must be able to work independently and manage a team, must have experience conducting quality control audits and data analysis/entry. Computer skills related to data management required. Excellent verbal and written skills are 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.

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.

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.

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Full time

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