Regional Clinical Research Associate

Position Title: Sr. Clinical Research Associate
Position Type: Locum / Per Diem Role working up to 20 hours/week; Remote US position with ability to travel up to 50%
Contract length: 6 months
Start: ASAP
Position Summary:
The purpose of the Sr. Clinical Research Associate position is to provide Study Monitoring for Client clinical studies. The Clinical Research Associate serves as a study monitor for compliance with Good Clinical Practices, and all National and Local Regulations. They may also perform the role of Lead Monitor on studies as required, and/or mentor a Study Monitor assigned to a project.
Job Responsibilities:
o Perform on-site or remote Monitoring Visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study Monitoring Plan
o Build and maintain successful working relationships with internal partners (e.g. clinical functions, RA, QA, R&D) and investigational site staff (e.g., investigators, research nurses, coordinators)
o Resolve Case Report Form (CRF) discrepancies
o Review/report AE/SAEs and protocol deviations per industry and Client standards
o Review documentation for ALCOA standards
o Assist with any site remediation activities, as applicable
o Ensure site(s) maintain an acceptable inventory and accountability of study devices and clinical supplies
o Communicate clearly and effectively with study sites
o Comply with investigative sites confidentiality requirements for monitors
o Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
Education and Experience:
o Bachelor's Degree or higher in a healthcare or science related field.
o Clinical background strongly preferred (e.g., Registered Nurse, Nurse Practitioner, or other licensed healthcare professional).
o Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need
o 5 or more years of relevant clinical research experience as a field based CRA in the device/pharmaceutical industry, including a multi-phase business knowledge of medical device or pharmaceutical product development
o Medical Device experience required
o Ability to travel up to 50%
Knowledge and Skills:
o Fluent knowledge of spoken and written English language, including medical terminology
o Superior written and verbal communication skills
o Proficiency in presentation preparation and delivery
o Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance
o Working knowledge of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
o Working knowledge of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPPA
o Ability to work in and promote team cohesiveness in a virtual/remote environment
o Demonstrated ability to prioritize multiple tasks with competing timelines and deliverables