Clinical Research Monitor (Office of Executive Dean - Research) job Miami Florid
Clinical Research Monitor (Office of Executive Dean - Research) job Miami Florid
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Clinical Research Monitor (Office of Executive Dean - Research) Job

Employer Name: SpiderID: 8870099
Location: Miami, Florida Date Posted: 8/13/2019
Wage: Negotiable Category: Science/Research
Job Code: R100034157

Job Description:

About This Position

The University of Miami, Miller School of Medicine's Office of the Executive Dean of Research has an exciting career opportunity for a Clinical Research Monitor. The Clinical Research Monitor is responsible for monitoring the progress of assigned Sponsor-Investigator initiated clinical studies to ensure studies are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP) and applicable regulatory requirements.

The duties and responsibilities for this position may include, but are not limited to:

  • Conducts 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.

  • Conducts 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 clinical data in regards 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 close out visits for the purpose of ensuring all clinical study data has been captured as required by the protocol, all subject participation visits have been completed, all essential records are filed and ready for long term storage and all SAE's/AE's have been reported and the study is ready for closure with the IRB and or FDA as applicable.

  • Verifies the investigator has adequate qualifications, facilities and resources and that they remain adequate throughout the clinical trial period until study closure.

  • 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.

  • 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 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.

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

  • Assists with the regulatory support to Principal 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.

Minimum Qualifications

Bachelor's degree in a science, health care, or closely related field of study. At least two years of experience working in a research environment, as a research nurse, in regulatory administration and/or clinical study coordination. This experience may also include monitoring experience within the clinical research industry at a Pharmaceutical/Biotechnology company, CRO or academic institution. Working knowledge of Good Clinical Practice (GCP), FDA regulatory requirements & ICH-GCP guidelines. Should have a job related certification (i.e. ACRP, SOCRA) or be able to obtain one within 1 year of employment. Must be able to work independently in addition to working within a team environment. Have the ability to manage multiple projects and assignments. Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology. Excellent verbal and written communication skills with proficiency in the English language. Possess a strong customer focus. Excellent interpersonal skills. Excellent organizational and time management skills with strong attention to detail. Ability to be flexible and adaptable. Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.

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.

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: University of Miami Health System Company Type:
Company: University of Miami Health System

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