Senior Clinical Research Associate

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Sitero

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.

📋 Description

• Primary point of contact for site personnel during life cycle of clinical trial. • Provides support to the Global Project Lead and CTM during project start up to ensure timely site selection and feasibility. • Assists with collection of essential documents from the site. • May assist with submission of central EC Applications, Local EC applications, RA applications and any other local regulatory applications/Approvals required. • Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety. • Conduct Site qualification, site initiation, routine site monitoring close out visits (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP. • Expert documentation of monitoring priorities/activities via site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs. • Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can impact data integrity. • Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings. • Assists the Global Project Lead in identification of out-of-scope activities. • Basic understanding of assigned projects scope, milestones and budget and manages site level activities to ensure project deliverables are met. • Provides support to the CTM and Global project lead in negotiation of site budgets and contracts.

🎯 Requirements

• At least three (3) years of independently monitoring drug trials experience with a Contract Research Organization • 5 + Years of experience independently monitoring drug trials required • Bachelor's degree or higher education in a science related field required • Previous Contract Research Organization or Pharma experience required • CNS (Central Nervous System) therapeutic alignment experience is highly preferred

🏖️ Benefits

• Competitive salary • Variable pay • paid time off • healthcare benefits • retirement benefits