Overview 

Lightship is the premier provider of enterprise level, technology enabled direct-to-patient clinical research. In this capacity, Lightship functions as a telemedicine-enabled site within a research study, which makes research participation possible for patients through the use of technology and home visits by our nurses. 

Lightship is seeking an energetic, independent, and compassionate individual to join our team as a part-time Clinical Internal Monitor.  

The Clinical Internal Monitor performs comprehensive internal audits and monitoring of ongoing clinical trials at Lightship. Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports. Performs extensive audits and monitoring visits to determine protocol compliance, including the consent process and eligibility criteria. Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, and any other source used to produce study data. Generates an audit report or monitoring report, summarizing the findings of all deviations, discrepancies, and incorrect or missing data. 

This is a part-time, remote opportunity.

You will be responsible for: 

  • Audits or monitors study data, including the consent process, eligibility criteria and case report forms, utilizing medical records, laboratory data, and any other source used to produce study data. Verifies that corrections to the source documents and / or CRFs are made correctly, if applicable. 
  • Audits or monitors study Investigator Site Files (ISFs), verifying that all essential documents are present and completed appropriately.  
  • Reviews the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures. 
  • Verifies that required reporting of Adverse Events (AEs) Serious Adverse Events (SAE) to sponsors has been completed within specified time frames 
  • Reviews the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures. 
  • Verifies that required reporting of protocol deviations, unanticipated problems, and Serious Adverse Events (SAE) to internal organizations (IRB, CPRMC, IBC, OSBC, RSC, DSMC) has been completed in a timely manner. 
  • Audits or monitors study data, including the consent process, eligibility criteria and case report forms, utilizing medical records, laboratory data, and any other source used to produce study data. Verifies that corrections to the CRFs are made correctly, if applicable. 
  • Generates audit reports and monitoring reports, summarizing the findings of all protocol deviations discrepancies, and incorrect or missing data.  
  • Other sturdy audit activities as required 
  • May be required to travel to other participating sites up to approximately 15% of the time to perform audits or monitoring of enrolled subjects as described above. 

We would like to offer you 

  • A platform to develop your clinical research and coordinating skills in healthcare 
  • An opportunity to help re-envision how clinical research is executed and deliver high-quality research outputs 
  • The chance to work with a patient-centered, clinically oriented, collaborative team to deliver enterprise grade direct-to-patient clinical research solutions at scale 

We are excited to speak with someone who has: 

Required knowledge, skills, and abilities 

  • Strong communication skills, including verbal, written, and presentational 
  • Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative 
  • Ability to start from scratch, execute quickly and accurately without pre-defined processes and protocols, and an interest in defining such processes for the future 
  • Exceptional ability to work as part of a team and to multitask effectively 
  • Basic computer skills and aAbility to function independently in a technology-enabled clinical researchremote work setting  

Education and experience 

  • Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields. 
  • Five or more years of experience as an industry Clinical Research Associate or clinical trial auditor or monitor. 

Preferred education experience and skills: 

  • Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA). 
  • Dermatology clinical trials. 
  • Experience managing clinical trials. 
  • Experience as a regulatory affairs administrator. 

Our commitment to diversity & inclusion:

Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, or sexual orientation or any other status protected by applicable law.

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