[Hiring] Senior Clinical Research Associate @Sitero LLC

Role Description

The Senior CRA (West Coast) will serve as the primary point of contact for site personnel during the life cycle of clinical trials, including:

• Study start-up support, site activation, trial conduct, and closeout of clinical trials.
• Providing support to the Global Project Lead and CTM during project start-up to ensure timely site selection and feasibility.
• Assisting with the 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.
• Identifying protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety.
• Conducting site qualification, site initiation, routine site monitoring, and close-out visits (remote and onsite) 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.
• Overseeing conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and potential breaches that can impact data integrity.
• Presenting essential functions of the CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face-to-Face meetings.
• Assisting the Global Project Lead in identifying out-of-scope activities.
• Basic understanding of assigned project scope, milestones, and budget, managing site-level activities to ensure project deliverables are met.
• Providing support to the CTM and Global Project Lead in negotiation of site budgets and contracts.

Qualifications

• Bachelor's degree.
• 5 years of experience with a CRO, including 3 years of independent drug trial monitoring experience.

Requirements

• At least 3 years of independent monitoring experience with a CRO.

Benefits

• Competitive salary.
• Paid time off.
• Healthcare and retirement benefits.

Commitments

• Standard hours: 40 hours per week, one hour lunch, Monday – Friday.
• Additional hours as needed.
• Willing to work in shifts as needed.
• Up to 80% travel for Days on Site visits.

Disclaimer

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.