Senior CRA, West Coast

🕒 October 6

🏄 California – Remote

🏄 California – Remote

💵 $120k - $145k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Serve as the primary point of contact for site personnel throughout the clinical trial lifecycle • Support study start-up, site activation, trial conduct, and clinical trial closeout • Support the Global Project Lead and CTM with site selection and feasibility • Assist with collecting essential site documents and regulatory submissions • Conduct site qualification, site initiation, routine monitoring, closeout visits, and central monitoring, remotely and onsite • Document monitoring activities through site visit confirmations, follow-up letters, monitoring visit reports, and trial logs • Review study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and potential breaches • Present CRA role functions in bid defenses, investigator meetings, and sponsor face-to-face meetings • Assist the Global Project Lead in identifying out-of-scope activities • Manage site-level activities to meet project deliverables • Support negotiation of site budgets and contracts with the CTM and Global Project Lead

🎯 Requirements

• At least 3 years of independent monitoring experience with a CRO • Bachelor's degree • 5 years of experience with a CRO • 3 years of independent drug trial monitoring experience • Ability to identify protocol deviations and pharmacovigilance issues affecting data accuracy or patient safety • Knowledge of ICH-GCP and clinical trial monitoring • Willingness to work shifts as needed • Willingness to travel up to 80% for Days on Site visits • Ability to work standard hours of 40 hours per week, Monday–Friday, with additional hours as needed

🏖️ Benefits

• Paid time off • Healthcare benefits • Retirement benefits • Competitive salary

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