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 Integral 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 (Ciudad de México)
🏢 Sitero
📍 Ciudad de México