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The Department of Executive Dean for Research is currently seeking a full time Clinical Research Monitor to work in Miami. The Clinical Research Monitor manages and facilitates the milestones of clinical studies in compliance with applicable clinical and regulatory standards related to human subject protocols.

CORE JOB FUNCTIONS  

 Monitors activities and manages clinical study sites to assure adherence to study Good Clinical Practices (GCPs), federal regulations, standard operating procedures, and study protocols.  

Reviews regulatory documents as appropriate. 

Assists with study development and start-up processes, including reviewing protocols, designing and reviewing CRFs, and preparing informed consent forms. 

Participates in clinical research training programs and maintains awareness of developments in the field. 

Evaluates quality and completeness of data, participant safety documentation, compliance with research regulations, and protocol adherence. 

Generates monitoring reports and follow up letters of visit findings, and tracks corrections to resolution. 

Maintains records of monitoring activities, reports, responses, and follow-up activities. 

Reports deficiencies and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented. 

Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements. 

Assists with the preparation and presentation of educational programs. 

Keeps abreast of regulatory and legislative changes that may affect current job functions. 

Adheres to University and unit-level policies and procedures and safeguards University assets.

Assists with developing the risk analysis, prepares monitoring plans as well as the centralized monitoring plans. 

Identifies potential risks, estimates the impact of such risks, and devises efficacious mitigation data review strategies for all assigned studies and subsites. 

Verifies the investigator has adequate qualifications, facilities and resources to conduct an investigator-initiated study and that they remain adequate throughout the clinical trial period until study closure.  

Assists in study start-up activities, including site selection and collection/review of regulatory documents, and ensures the site is qualified and ready to conduct the study. 

Monitors the clinical study progress for all assigned study sites, in addition to providing site management through frequent contact with the site staff by telephone, e-mail and monitoring visit.  

Assists investigators or institution with the conduct of site initiation visits for the purposes of ensuring clinical research key personnel have been trained on IRB approved protocols, study procedures, follow-up visits, patient recruitment, data collection/entry, investigational product dispensing/accountability/compliance, serious adverse event and adverse event reporting for assigned Investigator-Initiated clinical studies.   

Independently performs interim monitoring visits for assigned Investigator-Initiated clinical study sites (either onsite or remotely) to verify the subject rights and well-being are protected, verify the integrity of critical trial data in regard to accuracy, completeness and verifiable from source documents and to ensure the Sponsor-Investigator and/or Investigator obligations are being met and are compliant with applicable regulatory requirements, ICH-GCP guidelines and applicable UM policies and procedures.  

Conducts centralized monitoring of accumulated critical trial data for multi-site studies to review data completeness, outliers, variability, systematic errors and trends.  

Conducts monitoring close out visits for the purpose of ensuring that all study monitoring activities as dictated by the study monitoring plan have been completed.   

Verifying that investigational product is stored and dispensed properly and that receipt, use and return are controlled and documented adequately. 

Reviews essential regulatory documents for accuracy, completeness and appropriate filing.  

Generates monitoring reports and follow up letters of visit findings and tracks corrections to resolution.  

Maintains records of monitoring activities, reports, responses, and follow-up activities.  

Ensure compliance of study activities with appropriate local, state, ICH-GCP, and FDA regulations  

Reports deficiencies to the Investigators and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented.  

Ensures outstanding issues and/or action items are appropriately escalated for assistance in resolution. 

Ensure the reporting of high-quality data and timely query resolution by providing frequent reports to study sites. 

Collaborates with the clinical trials unit team and others to collect data/documents from sites within established timelines and assists in preparation for quarterly internal and external DSMB/C submissions.  

Keeps abreast of appropriate UM policies, regulatory and legislative changes that may affect current job functions.  

Provide advice to Sponsor Investigators and research teams in respect to the conduct and maintenance of IND and IDE studies.  

Maintains awareness of developments in the field of clinical research as needed.  

Ability to travel as needed, about 20%. 

Other duties as assigned. 

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.

Qualifications:

Education: 

Bachelor’s degree required. Health care, science or related field preferred.      

Certification and Licensing: 

CCRP, CCRC, CCRA certification or similar strongly preferred (or should be sought within one year of employment).  

Experience: 

A minimum of 1 year of experience working on a clinical trials team. Relevant positions include clinical research coordinator, research nurse, regulatory coordinator, monitor or similar.    

Knowledge, Skills and Attitudes: 

Knowledge of research-related federal regulations (FDA and HHS), guidance documents (ICH GCP) and state laws 

Excellent English skills, both verbal and written   

Excellent interpersonal and team skills 

Strong attention to detail, time/project management and organization skills 

Strong Microsoft Office (Excel, Outlook, PowerPoint, Word) skills  

Must be able to work independently in addition to working within a team environment 

Ability to manage multiple projects and assignments 

Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology  

Proficiency in using clinical trial management applications 

Excellent customer service skills. 

Ability to demonstrate self-directed and ration problem solving skills 

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.

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