Clinical Research Associate (CRA)

Vesper Medical

Wayne, PA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 05/27/2021
  • Website: www.vespermedical.com
  • Company Address: 640 Lee Road, Suite 101, Wayne, PA 19087

About Vesper Medical

Vesper Medical is a privately held company shaping the future of treating deep venous disease through the creation of the Vesper DUO Venous Stent System®, a next-generation, modular, and uniquely engineered venous stent portfolio that addresses the multiple anatomical challenges presented by the iliac and femoral veins and provides the ability to customize therapy to a broad range of patient needs.

Job Description

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

RESPONSIBILITIES

  • Ensure study compliance to SOPs, ICH-GCP guidelines, regulatory requirements, the study protocol, and overall study objectives.
  • Maintain a working knowledge of the study protocol, investigational device, and Clinical Affairs SOPs and Study Plans.
  • Assist with identifying and qualifying potential investigators via activities such as performing remote or on-site Qualification Visits.
  • Assist the In-House CRA and Project Manager with site start up activities including but not limited to essential document collection, review, and budget/contract negotiations.
  • Responsible for setting up the clinical site, which includes ensuring each site has the appropriate study materials and training required to conduct the trial.
  • Conduct Site Initiation Visits either remotely or in-person.
  • Serve as the main point of contact for the site from activation through close-out.
  • Collaborate with the Clinical Site Managers and members of the Clinical Affairs team to ensure alignment and successful execution of the study.
  • Monitor the study throughout its duration by 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 and/or source documents.
  • Track and report the progress of the study, including patient enrollment/screening, data monitoring, imaging upload, protocol deviations, issue resolution, and follow-up compliance.
  • Ensure device accountability is accurate and complete.
  • Ensure that the study staff complies with all safety reporting requirements.
  • Prepare and submit visit trip reports and Confirmation and Follow up letters within the required timeframe.
  • Ensure completeness and accuracy of the site regulatory binder.
  • Ensure clinical site training records are current and maintained as required.
  • May assist in the preparation and follow up of sponsored quality audits, as well as regulatory authority inspections.
  • Work with the site to ensure that study timelines and milestones are met.
  • 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.

The successful candidate must have / be:

  • Hands-on team player with the ability to work in a fast paced, dynamic startup environment.
  • Ability to think critically and make strategic decisions.
  • Experience working with small cross-function product/process development teams.

REQUIREMENTS

Education and Experience:

  • Advanced Degree or relevant industry experience
  • 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 PowerPoint
  • 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

Environment and Physical Functionality:

  • General office, laboratory and medical device research and manufacturing environment
  • Includes varying work schedule
  • Prolonged periods of sitting, standing and walking
  • Travel by automobile, train and aircraft (approximately 80% of the time), both domestic and international travel and occasional travel on weekends

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.