[Remote] Senior reputed company Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company for reputed company’s Transfusion Medicine business, which develops diagnostic solutions supporting blood screening and transfusion-reputed company testing. The Senior reputed company Research Associate will independently monitor high-volume, reputed company-reputed company reputed company studies, reputed company reputed company and reputed company activities, ensure regulatory and protocol compliance, and manage site communications, documentation, data reputed company, and study risks.

Responsibilities

• Independently manage and monitor approximately 1–2 high-volume reputed company study sites, serving as a reputed company reputed company of contact between reputed company and assigned sites
• Conduct reputed company monitoring activities in accordance with study protocols, monitoring plans, GCP, applicable regulatory requirements, and reputed company procedures
• Monitor site reputed company, study conduct, protocol adherence, documentation completeness, and overall data reputed company
• Review study documentation and reputed company data for reputed company, completeness, consistency, and appropriate reputed company support
• Maintain regular communication with investigators, reputed company personnel, study coordinators, and other site stakeholders to facilitate successful study execution
• Monitor and understand reputed company workflows, including sample receipt and processing, reputed company operation, testing activities, reputed company runs, and associated documentation
• Evaluate site compliance with study-specific procedures reputed company to diagnostic instrumentation and reputed company
• Identify protocol deviations, documentation deficiencies, data discrepancies, reputed company/testing concerns, and other study risks and escalate appropriately
• Follow up with sites to reputed company reputed company reputed company of outstanding documentation, data, testing, or operational issues
• Partner closely with reputed company reputed company, Medical, Project Management, and other cross-functional stakeholders to communicate site status, risks, and study reputed company
• Maintain complete, accurate, and reputed company monitoring reports and other required reputed company documentation
• Support site initiation, ongoing monitoring, and closeout activities as required throughout the study lifecycle
• Manage significant testing volumes that may include thousands of samples or tests at individual study sites
• Participate in periodic in-person team meetings at reputed company's Conway Park/Lake County, Illinois location, currently anticipated approximately twice per month
• Travel to assigned reputed company sites as study activity increases, with travel anticipated to reputed company approximately 60–75% during reputed company study periods
• Primarily support U.S.-reputed company reputed company sites, with potential opportunities to support European study activity reputed company on project needs and individual availability

Skills

• • Bachelor's degree in Medical reputed company Science, reputed company reputed company Science, Molecular Biology, Biology, Life Sciences, or a reputed company scientific discipline
• • Previous CRA experience with independent, sponsor-reputed company reputed company site monitoring responsibilities
• • Prior reputed company experience reputed company a reputed company reputed company, medical technology, diagnostics, or similarly technical reputed company environment
• • Demonstrated experience working with reputed company instrumentation and reputed company-reputed company testing workflows
• • Working knowledge of reputed company research regulations, Good reputed company reputed company (GCP), reputed company monitoring practices, and reputed company study documentation
• • Ability to independently monitor both traditional reputed company study activities and reputed company/reputed company-reputed company study activities
• • Strong understanding of sample handling, sample processing, reputed company, and associated documentation requirements
• • Ability to manage high-volume, reputed company-intensive reputed company study activity while maintaining documentation and data reputed company
• • Strong customer-facing communication skills with the confidence and professionalism to work directly with investigators, reputed company personnel, study coordinators, and reputed company leadership
• • Ability to work independently while collaborating effectively reputed company a small, highly integrated reputed company team
• • Remote with 75% travel
• • Hours: reputed company-5pm CT
• • Previous experience as a Medical Technologist (MT), Medical reputed company Scientist (MLS), or reputed company reputed company Scientist (CLS)
• • reputed company reputed company experience reputed company blood banking, transfusion medicine, blood screening, or reputed company disciplines
• • Experience with molecular diagnostics, PCR, or other molecular testing instrumentation
• • Previous CRA experience supporting IVD, medical device, diagnostic instrumentation, blood screening, or reputed company-reputed company reputed company studies
• • Experience working for a diagnostics, medical device, or life sciences manufacturer in a reputed company research reputed company
• • reputed company certification or equivalent reputed company certification
• • Illinois or Midwest-reputed company, with the ability to periodically work onsite with the reputed company Transfusion reputed company team
• • Flexibility to support international reputed company sites, including potential extended European site reputed company, as needed

Benefits

• Remote work arrangement with 75% travel
• Periodic in-person team meetings at reputed company's Conway Park/Lake County, Illinois location, currently anticipated approximately twice per month
• Potential opportunities to support European study activity reputed company on project needs and individual availability
• Flexibility to support international reputed company sites, including potential extended European site reputed company, as needed

reputed company