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Senior Clinical Research Associate

3+ years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Research Associate

Department: Clinical Services
Location: Mexico City, Mexico (Remote)
Employment Type: Contractor
Minimum Experience: Mid-level

Company Overview:

Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. With expertise across a wide range of therapeutic areas, Sitero focuses on innovative, technology-enabled solutions that allow clients to concentrate on their core strengths. From early-phase studies through Phase III clinical trials, Sitero delivers high-touch services and technologies emphasizing ethics, compliance, and innovation.

Job Title:

Senior CRA (Contract)

Function:

Clinical Operations

Mandatory Experience:

At least 1 year of independent monitoring experience with a CRO is required.

Essential Duties and Responsibilities:

  • Serve as the primary point of contact for site personnel throughout the clinical trial life cycle, including study start-up, activation, conduct, and closeout.

  • Provide start-up support by assisting the Global Project Lead and CTM with site selection, feasibility assessments, and collection of essential documents.

  • Assist with submissions to central and local Ethics Committees (EC) and Regulatory Authorities (RA) as required.

  • Identify protocol deviations and pharmacovigilance issues affecting data accuracy or patient safety.

  • Conduct site qualification, initiation, routine monitoring, and closeout visits (both remote and onsite) in compliance with study protocol and ICH-GCP guidelines.

  • Document monitoring activities through confirmation letters, follow-up letters, monitoring visit reports, and maintenance of trial logs.

  • Oversee trial conduct by reviewing study data listings, vendor dashboards, and CTMS documentation to detect trends, errors, and potential breaches impacting data integrity.

  • Present CRA role responsibilities during Bid Defenses, Investigator Meetings, and Sponsor Face-to-Face meetings.

  • Assist the Global Project Lead in identifying out-of-scope activities.

  • Understand project scope, milestones, and budgets; manage site-level activities to ensure deliverables are met.

  • Provide support in negotiating site budgets and contracts.

Education and Experience Required:

  • Minimum 1 year of independent monitoring experience.

  • At least 3 years of experience in clinical research within a CRO, Biotech, or Sponsor environment.

  • Experience in Women’s Health studies preferred.

  • Ability to travel throughout Mexico approximately 60% of the time.

Compensation & Benefits:

  • Contractor hourly rate, paid once per month.

Employment Type:

  • Part-Time Contract.

Commitments:

  • Standard 40 hours per week, Monday–Friday, with a one-hour lunch break.

  • Additional hours and shift work as needed.