Clinical Research Monitor (EDR) job Miami Florida
Clinical Research Monitor (EDR) job Miami Florida
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Clinical Research Monitor (EDR) Job



Employer Name: SpiderID: 12154263
Location: Miami, Florida Date Posted: 2/24/2022
Wage: Negotiable Category: Science/Research
Job Code: R100052661

Job Description:



Job Summary:

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.  



Primary Duties and Responsibilities:




  • 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 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 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. 

  • Other duties as assigned. 




Customer and Partner Interactions: 

Regularly interacts with Investigators and members of the clinical research team, and various UM departmental staff members as needed to conduct research. 




Success Indicators: 



  • 100% of the time monitoring visits will be conducted according to assigned study site's monitoring plan unless otherwise indicated. 

  • At least 90% of the time completion of monitoring visit reports and follow up letters in a timely manner. 





Minimum Qualifications:



  • Bachelor's degree in science, health care, or related field required. Master's degree preferred.   

  • Working knowledge of Good Clinical Practice (GCP), FDA regulatory requirements & ICH-GCP guidelines. 





Certification and Licensing:



  • Should have a job-related certification (i.e., ACRP, SOCRA) or obtain one within 1 year of employment. 



Experience:





  • A minimum of 1 years of relevant experience working in a research environment, research nurse, regulatory administration or study coordination is preferred. 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

  • High-level interpersonal skills are preferred

  • Excellent English oral and written communication skills and strong computer skills are required

  • Maintains job related certifications (i.e., ACRP, SOCRA)







  • Any appropriate combination of relevant education, experience and/or certifications will be considered



Knowledge, Skills and Attitudes:



  • 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 

  • Excellent English oral and written communication skills 

  • Strong customer focus 

  • Excellent interpersonal skills 

  • Excellent organizational and time management skills, 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 






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
City:
State:
Zip:

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