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Clinical Research Associate

Prosidyan, Inc.


Location:
Warren Township, New Jersey 07059
Date:
03/27/2018
2018-03-272018-04-26
Categories:
  • Clinical Operations
Prosidyan, Inc.
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Job Details

Prosidyan Inc., founded in 2009, is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass.

We have an exciting opportunity for a results and solutions oriented Clinical Research Associate/Specialist to join our team. The Clinical Research Associate/Specialist will be responsible for the generation of high quality clinical evidence in support of company operations by overseeing clinical research tasks in an office and clinical setting. These tasks will include collecting clinical data in the field, managing clinical study sites, ensuring quality data, maintaining study compliance with applicable federal and international regulatory requirements while maintaining strong customer relationships. Critical knowledge of synthetic biomaterials, product applications, indications, and efficacy will be developed through design, support, and conduction of clinical trials.

This position will involve 60% travel to interact with clinicians and surgeon champions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • In collaboration with experts and external consultants, design, write, and conduct clinical studies and trials in compliance with applicable clinical and regulatory standards.
  • Monitor and maintain a database of the clinical use of Prosidyan products.
  • Oversee data collection and ensure accuracy and timeliness of data
  • Compile, review, and analyze results; write reports; perform pre-publication review and editing.
  • Develop a deep understanding of products, applications, efficacy, and that of competitors
  • Collaborate with and present to current and prospective surgeons and distribution partners; maintain strong customer relationships.
  • Assist in the design, development or testing of new products
  • Ability to receive field feedback on products and effectively transfer the information back to the R&D group.
  • Support other areas of the organization by sharing knowledge, and educational, professional, or promotional presentations.

Qualifications Include:

  • Masters or PhD in Biology, Biomaterials or Tissue Engineering; or BS/MS in Nursing or Physician Assistant Studies.
  • 1-5 years of experience as a nurse, physician’s assistant, or position directly supporting clinical research, monitoring or relevant experience in medical/scientific area.
  • Experience collecting clinical data in the field: surgeon offices, operating rooms, and labs; and demonstrated technical writing skills.
  • Knowledge of healthcare related field(s) and clinical outcomes studies
  • Knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
  • Knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
  • Strong interpersonal skills: Ability to effectively interface with surgeons to educate, inform, discuss study design and outcomes; represent the company, build relationships.
  • Presentation and public speaking ability
  • Good prioritization and organizational skills with high attention to detail and accuracy.
  • Proficient with Microsoft Word, Excel, PowerPoint.
  • Orthopedics or Spine industrial or clinical knowledge and experience a plus
  • Knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485 and ISO 14155, a plus.
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