Clinical Research Monitor - Population Health Science & Policy

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 
Roles & Responsibilities:
The Clinical Research Monitor supports the field activities for the conduct of clinical research studies in compliance with applicable regulatory standards, IRB policies and procedures and internal requirements. He/she will play an integral role in verifying data from multi-center clinical trials. The incumbent will report directly to the Program Manager and work collaboratively with the clinical trial Research Coordinators, Project Managers, Coordinating Center and others on the responsibilities for verification of data collection on grant-funded genomic implementation pragmatic clinical trials. 
  • Oversee and review routine and moderately complex site activities through monitoring activities, including remote monitoring and in-house assessments, using computer, telephone and other technologies according to the trial-specific monitoring plan to assess protocol, regulatory, and SOP compliance.
    • Independently perform monitoring activities for multiple sites and multiple projects, identifying and reporting deviations from regulations and SOPs. Assess protocol and regulatory compliance, including but not limited to source document verification, informed consent process and human subject protection, data integrity, and review of investigator and regulatory files.
    • Provide study training and guidance to designated site personnel for conducting studies in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Identify situations that may affect subject safety or data integrity and retrain site personnel accordingly.
    • Identify action items and discuss with appropriate site personnel. Communicate routine and unusual findings to trial supervisors. Document ongoing follow-up and resolution of issues. Recognize ongoing action items and coach site personnel to improve their performance.
    • Independently document site management and clinical monitoring activities, site communication, and trial related activities. Utilize monitoring tools and trial documents, recommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes; independently develop study-specific versions as directed.
    • Regularly review and update study and site status information into required systems to maintain accurate, current reports.
    • Maintain essential trial and site communication records, electronic and hard copy, to meet trial and organizational and sponsor standards as directed.
    • Develop and implement action plans for resolution of routine and complex site and study issues. Follow up on outstanding issues including ongoing documentation.
  • Manage and review routing and moderately complex site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established practices. Recommend improvements for data collection and data processing and implement efficiencies as directed.
    • Review specified patient data and source documents. Appropriately report safety concerns, protocol deviations or unexpected data trends.
    • Review data status reports and follow-up with sites regarding missing and/or late data. Observe for trends and coach sites to improve performance.
    • Provide training for site personnel on appropriate source documentation, CRF completion, data procedures and timelines, and query resolution. Review data queries, assist sites with query resolution and follow up on outstanding queries
  • Build and maintain effective working relationships with site personnel, internal and external study contacts.
  • Provide routine updates and moderately complex reports to trial supervisor(s) and other assigned contacts to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities.
    • Communicate with teammates to consolidate accurate and complete assessments of sites’ activities. Routinely report updates to trial supervisor without prompting.
    • Independently assess findings and recommend resolution of complex issues, utilizing trial supervisor as a resource to verify proposed plans.
  • Serve as a resource to other team members for day-to-day trial activities. Assist with training and mentoring less experienced personnel.
  • Develop site training materials, including site initiation activities, agendas, slides, and study tools
  • Participate in regular teleconferences, staff meetings, etc.
  • Perform other related duties incidental to the work described herein. Other duties may include, but are not limited to: assisting with recruitment of study participants, assisting trial supervisors and peers in the preparation of IRB submissions, grant proposals, presentations to scientific and community audiences, manuscripts, and progress reports 
Requirements:
  • BA/BS required; Master’s degree in a health-related field preferred 
  • At least 2 to 3 years of research experience, ideally working with diverse populations
  • Strong interpersonal skills; ability to establish and promote positive business relationships; customer service oriented
  • Ability to collaborate with study staff and internal and external partners to achieve goals
  • Proficient computer skills including MS Word, Excel and PowerPoint and familiarity with web-based data collection systems preferred
  • Strong organizational skills and attention to detail
  • Ability to perform multiple activities at once to accomplish individual and team goals with competing deadlines
  • Strong problem analysis and resolution skills
  • Ability to perform routine site management and monitoring activities independently
  • Ability to travel off site and to study meetings, as needed
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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