Clinical Affairs Specialist

Seattle, Washington

Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 150972

Date Posted: 03/30/2020

Title: Clinical Affairs Specialist

Duration: Direct, Full-time Employee

Location: Field based-up to 75% travel, preferred locations AZ/WA/OR/NV/CA

Joule is seeking a Clinical Affairs Specialist for an innovative medical device company. The ideal candidate will possess 5+ years of experience and have medical device, respiratory, or neurostimulation experience and have a strong background in clinical care or nursing. This position will report direct to the VP of Clinical Affairs. Candidates must be willing to travel up to 75% of the time. Preferred locations AZ/WA/OR/NV/CA.

Job Description

  • Assists with all facets of the management of clinical trials including development
    of clinical protocols and CRFs and understanding of data entry processes
  • Takes full responsibility for assigned regions/accounts which includes but is not limited to:
    • Site identification, selection, qualification
    • Responsible for driving enrollment to achieve company goals for all clinical protocols;
    • Supports all facets of the trial activities which includes support of the ongoing patient therapy as needed
    • Assist sites with contracts/budgets/investigator agreements and consents for trial activities
    • Site initiation and ongoing training and education of coordinators, physicians and support staff as necessary
    • Available to travel to clinical trial sites when need arises both during clinical trials and after product market approvals
    • Encompasses thorough knowledge and application of regulations for clinical trial conduct and good clinical practice
  • Educational support of customer base to include the development and presentation
    of training and marketing tools for all clinical activities and commercialization as needed
  • Participation in meetings, seminars, tradeshows as needed;
  • Provides case support and patient support during trials and after commercialization as needed
  • Assist with the review of adverse event information
  • Works closely with R&D department and provides on-site technical support as deemed necessary
  • Able to develop and nourish strong sustainable relationships within the account to assure strong enrollment
  • Support research and development by gathering information from the medical
    community and communicating this information to the engineering and R&D team
  • Interacts with in-house quality, regulatory, R&D, data management and monitors

Job Qualifications and Experience

  • Requires some type of degree in nursing, medicine, biology or biomedical engineering with a focus on clinical
  • Must have at least 6 years’ experience with medical device companies with a minimum of 5 years clinical trial research background
  • Strong project management capabilities
  • Able to work independently
  • Knowledgeable about GCP guidelines
  • Experience with the education and training of physicians and hospital support staff
  • Experience in the Cath lab, OR or ICU environment a plus
  • Experience with implantable devices or neurostimulation a plus