link to Video of Tack Endovascular System

This animation is provided for general information only. It is not intended to provide clinical instructions for use (IFU). Always read and understand the IFU supplied with the device prior to use.

CAREERS

To apply for any of the below openings, please submit your resume to info@intactvascular.com.

Clinical Site Manager (CSM)

The CSM supports multiple activities for the conduct of clinical research studies, operations and special projects in compliance with applicable regulatory standards, IRB/EC policies and procedures and Intact Vascular internal requirements.  This position works with minimal supervision and directly with study management and the study team.

Principle Responsibilities

  • Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. 
  • May assist in preparation of sections of the Investigational Plan, study materials and/or training.
  • Will interface with, and ensure training of investigators, site staff, and assigned Intact Vascular staff. 
  • Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review) and site closeout activities.
  • Responsible for coordinating field activities with clinical site needs to ensure enrollment and study execution.
  • Assist in follow-up and resolution of site issues. 
  • Assist in review of adverse event information. 
  • Assist in device allocation, reconciliation and compliance, review, and conclusion of device complaints.
  • Assist in preparation of annual, interim and final reports and presentations.
  • May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs).
  • Able to refer to Standard Operating Procedures (SOPs) for guidance on everyday study tasks.
  • Contribute to ongoing SOP development and review.
  • Participate in training to enhance knowledge base.

Secondary Responsibilities

The successful candidate must have / be:

  • Strong verbal and written communication skills, technical and problem solving skills
  • Able to read, analyze and interpret general business documents, technical procedures, and standard operating procedures
  • Able to work effectively, independently and on cross-functional teams
  • Able to write reports, business correspondence and procedure manuals effectively
  • Able to frequently use general knowledge of industry regulations, practices, techniques, and standards
  • Develop solutions to a variety of problems of moderate scope and complexity
  • Able to refer to policies and regulations for guidance

The above statements are intended to describe the general level of work being performed by people assigned to this job.  They are not intended to be an exhaustive list of all responsibilities.

Job Requirements

  • Education Level: Bachelor’s Degree and 1+ year of experience in clinical / clinical research setting.
  • Knowledge of ICH and GCP Guidelines
    Strong computer literacy with Microsoft Office

Additional Skills

  • Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
  • Understanding of Clinical Operations
  • Experience working with small cross-function product/process development teams.
  • Able to generate and communicate project strategies and scenario plans to team members, management, board members, etc.
  • Ability to work independently

Special Requirements

  • Environmental Situation
    • General Office Environment
    • Medical Device Research Manufacturing Environment
    • International and Domestic Travel
  • Physical Functionality
    • Varying work schedule
    • Prolonged periods of standing, sitting and walking
    • Up to 80% overnight travel by automobile, aircraft and train
    • Occasional weekend travel

Clinical Research associate (CRA)

The CRA is responsible monitoring and management of clinical sites for trials conducted by Intact Vascular. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with CRF, ICH/GCP guidelines and Intact Vascular’s Standard Operating Procedures.

Principle Responsibilities

  • Assure study compliance to SOPs, ICH-GCP guidelines and regulatory requirements.
  • Assist with identifying and qualifying potential investigators. Perform Site Qualification Visits. Assist In-House CRA and Study Manager with site start up activities including essential document review, collection, IRB review, budget/contract negotiations and approval process.
  • Responsible for setting up the clinical site, which includes ensuring each site has the appropriate study materials, including devices.
  • Ensure that the site staff is appropriately trained on study specific industry standards.
  • Will monitor the study throughout its duration, involving visiting the site on a regular basis, as stipulated in the monitoring plan.
  • Verify that the data entered onto the CRFs are consistent with patient clinical notes or source documents.
  • Ensure compliance with study protocol, CRF, GCP/ICH and overall clinical objectives.
  • Track and report progress of study, including patient enrollment/screening, data monitoring, protocol deviations, issue resolution and follow up compliance.
  • Ensure device accountability is accurate and complete.
  • Ensure that the study staff complies with the serious adverse event reporting requirements.
  • Prepare and submit visit trip reports, Confirmation and Follow up letters within timelines outlined in the Clinical Monitoring Plan.
  • Ensure clinical site training records are current and maintained as required.
  • May assist in the preparation and follow up of on-site sponsored quality audits, as well as regulatory authority inspections.
  • Assist Data Management as requested.
  • Identify data discrepancies, trends, and other analytics related to site performance.
  • Attend staff meetings and trainings as required.
  • Adhere to Clinical Operations or project specific quality documents (i.e. SOPs, Work Instruction, etc.) as applicable.
  • Other duties may be assigned as deemed necessary by the supervisor.
  • This position requires approximately 80% travel, may include international travel.

Job Requirements

  • RN or BA/BS required.
  • Minimum 5 years’ experience in Clinical Research
  • Preferably 2-4 years’ experience in Device Monitoring
  • Cardiology and/or Vascular experience a plus
  • Previous Study Coordinator experience a plus
  • Strong working knowledge of Microsoft Excel and Power Point
  • Proficiency with software applications for PC
  • Excellent time management and communication skills (written, verbal)
  • Able to set priorities and be flexible within a fast-paced environment

Additional Skills

  • Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
  • Experience working with small cross-function product/process development teams.
  • Ability to travel to home office when not on-site or as requested by manager. 

Environmental Situation:

  • General Office Environment
  • Laboratory Environment
  • Domestic and International Travel
  • Medical Device research and manufacturing environment