Senior Clinical Research Associate

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.  
• 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. 

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.