Research Director

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Irfa******

  • United States 
  • Last Update: 18.03.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
New York, New York
Country
United States

Category


Regulatory, Quality and Clinical

Description


Experience Preferred:

  • Science education within a STEM field (medical / healthcare focus desirable)
  • Training or advanced degree in clinical research discipline
  • Managing study and departmental budgets
  • Knowledge and/or training in application of digital health solutions
  • Leading and supporting identifying and securing funding for a range of validation studies
  • Confirmable success in conducting clinical research (both small and large trials, experiential and registration)
  • Involvement with medical device and/or pharmaceutical and/or digital health registry trials.

Skills:

  • Business communication skills (public speaking and writing)
  • Flexible with well-developed critical thinking skills
  • Must be comfortable in fast paced, agile environment
  • Understanding of technical medical terminology
  • Strong methodological and statistical skills
  • Comfortable and credible in public speaking with ability to clearly present scientific and clinical data to clinicians, sponsors, and partners

Responsibilities:

  • On site management of clinical research teams, focusing on driving clinical trials to rapid enrollment and timely completion.
  • Team responsibilities include:
  • Drafting clinical trial protocols, reports, and submissions for publication
  • Determination of study costs and timing
  • Preparation of trial-related paperwork
  • Coordination of sample evaluation with third-party laboratories
  • Data collection and coordination
  • Coordination of test material delivery to investigation sites
  • Reporting of study progress to management
  • Preparation of advertising for recruitment
  • Monitoring of enrollment status
  • Data management and adverse event reporting
  • Creation and monitoring of study timelines
  • Coach, manage and support research staff
  • Adherence to the HITLAB processes, standards quality management system

Etc.

  • Work closely with other HITLAB senior leaders on-site for business development including planning and forming external, sponsor-facing clinical educational / marketing material, such as publications, conference presentations, symposia, development of scientific advisory boards, etc.
  • Developing and maintaining relationships with clinical thought-leaders in relevant fields of life sciences, digital health fields and major technology companies with healthcare ambitions
  • Oversees all aspects of HITLAB clinical development processes, including establishing appropriate frameworks, tools, SOPs, training materials, etc. for fully

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