Clinical Program Manager, Minidich Child Health & Development Institute

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 
 
Roles & Responsibilities:

The candidate will be an integral member of the senior leadership team within the Clinical Trials Office. Responsibilities include but are not limited to: coordinating the data management activities of the CTO while providing supervision and delegation of work assignments and evaluation of the CTO Clinical staff; creating and promoting professional development opportunities (both internally and externally) for staff; implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships.

 

Duties and Responsibilities:

  • Oversees the conduction of multiple projects; provides overall research program management and creates a timeline and a plan to achieve program goals
  • Identifies hires and manages research staff and/or develops training of personnel
  • Identifies staff development needs and provides internal/external opportunities or continuing education
  • Ensures annual competencies required by the hospital, OSHA, JCAHO are completed
  • Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals)
  • Controls costs through the economical utilization of personnel, materials, and equipment
  • Ensures accurate, ethical, and appropriate management of patients in compliance with all institutional and federal regulations
  • Oversees the tracking of study income/expenditures in relation to program management
  • Provide guidance to investigators in the planning, design, and execution of clinical trials, including protocol development and feasibility
  • Ensures team is adequately prepared for and successfully manage all monitoring and/or auditing visits
  • Provides Quality Assurance Oversight to Protocols including producing data quality, timely submission, and query resolution
  • Develop standardized forms, study tools, and promote cross-coverage with Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.
  • Serves as liaison between research program and external contacts: sponsors, regulatory agencies, physicians, patients, etc.
  • Review of industry sponsored research protocols to ensure study feasibility and practicality. Working closely with the Research Director, provide guidance to divisions regarding the potential for competing research trials, feasibility of enrollment and potential contracts and budget issues
  • Resolve research protocol specific issues with institutional review committees including the IRB (Program for the Protection of Human Subjects), CRC (Clinical Research Center), Board and pharmaceuticals companies regarding specific projects including budgets and contracts
  • Develop standardized forms, study tools, and promote cross-coverage with Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.
  • Initiates and participates in staff recruitment and retention activities for staff
  • Directs day-to-day administrative operations
 
 
Requirements:
  • Master’s degree in a related field; Bachelor’s Degree in Nursing – preferred but not required
  • Certification/maintenance of certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) required
  • Demonstrated leadership skills and management training and experience required
  • 5-7 years of experience in clinical research OR 2 years of experience as a Clinical Research Coordinator, Lead with a demonstrated leadership role in developing, implementing, and evaluating the conduct of clinical research; has been or is capable of performing the majority of Clinical Research Coordinator, Lead responsibilities
  • Strong project management skills and experience, including managing external CROs
  • Knowledge and experience with FDA regulatory requirements needed
 
 
Strength Through Diversity
 

The Mount Sinai Health System believes that diversity 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 medicine together.

 

We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make 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 hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel 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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