Senior Clinical Research Associate (Contract)

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. 

This role will involve regulatory work to get the country and sites approved through the Regulatory Authority (RA) and Ethics Committees (ECs), as well as site activities from feasibility through close out visits.  The ability to perform both Reg and CRA duties is required.

Job Title: Senior Clinical Research Associate (Contract)                   

Location: Moldova (Remote)     

Function: Clinical Operations and Regulatory              

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. applications/Approvals required.
• Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety.
• Familiarity with regulations surrounding conduct of clinical trials in all countries pertinent to your contract
• Knowledge and ability to perform throughout the duration of the study any RA submissions, Central EC submission, Local EC submission, and any other country specific submissions required
• 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:

• 5 years of experience independently monitoring clinical drug trials
• Completed at least 2 clinical trial application submissions in the past 5 years in each country pertinent to your contract
• Rare Disease; Hepatology and Gastrology experience required
• Bachelors degree in a life science field required

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Contract; 0.5-0.75 FTE availability required.

COMMITMENTS:

• 5-0.75 FTE availability
• Willing to work in shifts as and when needed.
• Ability to travel up to 80% for site monitoring and regulatory purposes
• Ability to lift 1-50 pounds at varying times
• Ability to stand for long durations, kneel, bend, and sit for varying periods of time

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.