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 monthsStart: ASAPJob DescriptionPosition Summary: The purpose of the Sr. Clinical Research Associate position is to provide Study Monitoring for BD 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: oPerform on-site or remote Monitoring Visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study Monitoring Plan oBuild 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) oResolve Case Report Form (CRF) discrepancies oReview/report AE/SAEs and protocol deviations per industry and BD standards oReview documentation for ALCOA standardsoAssist with any site remediation activities, as applicable oEnsure site(s) maintain an acceptable inventory and accountability of study devices and clinical supplies oCommunicate clearly and effectively with study sites oComply with investigative sites confidentiality requirements for monitors oComplete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training Education and Experience: oBachelor’s Degree or higher in a healthcare or science related field. oClinical background strongly preferred (e.g., Registered Nurse, Nurse Practitioner, or other licensed healthcare professional).oConsideration of a candidate with any alternate level of education will be case-dependent based on experience and positional needo5 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 oMedical Device experience required oAbility to travel up to 50% Knowledge and Skills: oFluent knowledge of spoken and written English language, including medical terminologyoSuperior written and verbal communication skills oProficiency in presentation preparation and delivery oTechnical savviness with an ability to understand the impact technology has on increasing effectiveness and performance oWorking knowledge of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc. oWorking knowledge of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPPAoAbility to work in and promote team cohesiveness in a virtual/remote environment oDemonstrated ability to prioritize multiple tasks with competing timelines and deliverables Enable Skills-Based Hiring No Industry Title Clinical Research AssociateJob Group 3Project Name (No Value)Contract to hire position UnknownShift N/AScreening Requirements N/A 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 7.25/hr.