Senior Clinical Research Associate (Xico)

Senior Clinical Research Associate (Xico)

16 ago
|
Sitero
|
Xico

16 ago

Sitero

Xico

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry.We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths.For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
- Job Title_: Senior CRA (Contract)- Location_: Mexico- Function_: Clinical Operations**Mandatory Experience: At least 1 year of independent monitoring experience with a CRO****ESSENTIAL DUTIES AND RESPONSIBILITIES**:- Primary point of contact for site personnel during life cycle of clinical trial.This includes study start up support, site activation, trial conduct and closeout of a clinical trial.
- 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 General project lead in negotiation of site budgets and contracts.
**EDUCATION AND EXPERIENCE REQUIRED**:- 1 year of independent monitoring experience- 3 years minimum in Clinical Research with a CRO, Biotech, or Sponsor- Experience in Women's Health Studies Preferred- Ability to travel to Sites throughout Mexico 60% of the time**COMPENSATION & BENEFITS**:Contractor Hourly Rate paid once per month**EMPLOYMENT TYPE**:Part-Time Contract**COMMITMENTS**:- Standard Hours 40 hours per week, one hour lunch, Monday - Friday.Additional hours as needed.
- Willing to work in shifts as and when needed.

📌 Senior Clinical Research Associate (Xico)
🏢 Sitero
📍 Xico

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