Prosidyan Inc., founded in 2009, is thecreator and supplier of the next generation in synthetic bone grafting throughits proprietary manufacturing process utilizing microscopic fibers of bioactiveglass.
We have an exciting opportunity for aresults oriented Clinical Research Associate to join ourteam. The CRA will be responsible for thegeneration of high quality clinical evidence in support of company operationsby overseeing clinical research tasks in an office and clinical setting. Thesetasks will include ensuring quality data, maintaining study compliance withapplicable federal and international regulatory requirements while maintainingstrong customer relationships. Critical knowledge of synthetic bio-materials,product applications, indications, and efficacy will be developed throughdesign, support, and conduction of clinical trials.
ESSENTIAL DUTIES ANDRESPONSIBILITIES:
- Incollaboration with experts and external consultants, design, write, and conductclinical studies and trials in compliance with applicable clinical andregulatory standards.
- Monitor andmaintain a database of the clinical use of Prosidyan products.
- Oversee datacollection and ensure accuracy and timeliness of data
- Compile,review, and analyze results; write reports; perform pre-publication review andediting.
- Develop a deepunderstanding of products, applications, efficacy, and that of competitors
- Collaboratewith and present to current and prospective surgeons and distribution partners;maintain strong customer relationships.
- Perform Research& development activities as needed such as preclinical studies, bio-compatibilitystudies, design (end user) validations.
- Assist in thedesign, development or testing of new products
- Ability toreceive field feedback on products and effectively transfer the informationback to the R&D group.
- Supportother areas of the organization by sharing knowledge, and educational,professional, or promotional presentations
- Bachelors orMasters degree in Biomaterials or Tissue Engineering.
- 1-3 years ofexperience in a position directly supporting clinical research activitiesincluding monitoring;collecting clinical data in the field (surgeon offices, operating rooms, andlabs); and demonstrated technical writing skills.
- Experience in statisticalsampling, data analysis and planning.
- Knowledgeof healthcare related field(s) and clinical outcomes studies
- Knowledge of Good Clinical Practice (GCP) andregulatory compliance guidelines for clinical trials
- Knowledge of World Health Organization (WHO) GoodClinical Practice (GCP) and International Conference on Harmonization (ICH)
- Strong communication, presentation and publicspeaking skills. Ability to effectivelyinterface with surgeons to educate, inform, discuss study design and outcomes;represent the company, build relationships.
- Good prioritization and organizational skillswith high attention to detail and accuracy.
- Proficient with Microsoft Word, Excel, PowerPoint.
- Orthopedics or Spine industrial or clinicalknowledge and experience a plus
- Knowledge of Quality System Regulation (QSR 21CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical DeviceDirective (EU MDD 93/42 EEC), and ISO 13485 and ISO 14155, a plus.
Job Type: Full-time
- collecting clinical data and monitoring in the field: 1 year (Required)
- GCP & compliance guidelines for clinical trials: 1 year (Required)