Cliinical Trials Analyst, Medicine

Job Description


Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 

The Clinical Trials Analyst assists School of Medicine Faculty in submission, review and analysis of clinical trials submissions, ensuring accuracy and appropriateness, consistent with prevailing regulatory requirements. Develops and maintains timelines for study results, postings and follows up on issues in a timely fashion. Prepares metrics reports to senior leadership for review as requested.

 

Roles & Responsibilities:

 
  • Creates documentation to assist responsible parties submit their clinical trials records for results reporting
  • Performs reviews of clinical trials results submissions for consistency with review criteria and to ensure regular (at least every six months) updates to all records
  • Performs reviews of current postings and follows up on any potential discrepancies that require addressing urgently due to non-compliance or out-of-window reporting
  • Develops and updates standard operating procedures for the institution in compliance with federal regulations
  • Prepares metrics for review by senior leadership on P.I. and other departmental issues
  • May assist with development of corrective action plans for non-compliant P.I,’s or departments
  • Ensure transferring investigators complete, transfer and/or update the clinicaltrials.gov responsibilities prior to their departure
  • Collaborates closely with the PPHS, GCO, OCR, Biostatistics and Research Compliance as appropriate
  • Develops and maintains reportable timelines for posting updates, study results and/or close-outs and alerting P.I.’s to their expectations
  • Assists with the development of an institutional subject recruitment plan in collaboration with the TRAC team
  • Clearly communicates with responsible parties (i.e., clinical trials sponsors, designated P.I.’s and/or statisticians) regarding consistency of clinical trials results with review criteria
  • Other duties as assigned
 
Requirements:
  • Education: Master’s degree from accredited college in a public health and/or mathematic related discipline (epidemiology, biostatistics, statistics, etc.) preferred
  • Experience: (2) years minimum of clinical trials experience as either a research data coordinator or clinical coordinator. Background knowledge relevant to understanding/interpreting clinical trial data and statistics
 

Strength Through Diversity

 

The Mount Sinai Health System believes that diversity and inclusion is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize healthcare delivery together.

 

We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care. 

 

Explore more about this opportunity and how you can help us write a new chapter in our story! 

 
Who We Are
 

Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.

 

Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.

 

The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation. 

 

EOE Minorities/Women/Disabled/Veterans


 

 

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