Clinical Lab Scientist I

Role: Clinical Lab Scientist I (Contract Role)

Location: Tucson, AZ

Description:

***This is a first shift position (9:00 AM to 6:00 PM, M-F) for a Clinical Lab Scientist.

Key Requirements

• Bachelor's degree in Life Sciences (BA/BS)
• 1-3 years of experience in a clinical lab setting; histology or IHC experience preferred
• Demonstrates strong teamwork and adaptability, combining a willingness to follow direction with the self-motivation needed to deliver consistent results.
• Preferred: Histotechnologist certification (HT or HTL)

The Opportunity

• Lead clinical and medical research studies
• Analyze clinical trial data and publish findings
• Ensure compliance with medical research regulations
• Collaborate with healthcare professionals and research teams
• Support drug and therapy development efforts
  

Who You Are

• 1-3 years of experience
• Strong problem-solving skills
• Excellent communication abilities
• Knowledge of industry best practices

Preferred (Optional)

• Experience in clinical trials preferred

Informed Consent Form (ICF) Management:

• Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices Clinical Trial Submissions & Regulatory Coordination:
• Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle. Site Documentation & Compliance:
• Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed.
• Oversee translation and approval of drug labels and patient-facing materials, as required
• Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs

Budgeting & Contract Management:

• Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting
• Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

Qualifications

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master's degree highly desirable
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
• Experience managing vendor/CRO relationships
• Proven leadership or line management experience (for PLs) Skills & Competencies
• Excellent communication and interpersonal skills
• Strong organizational, analytical, and problem-solving capabilities
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
• Collaborative and adaptable mindset with attention to detail
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams
• Fluency in written and spoken English is mandatory.
• Fluency in written and spoken language(s) of the host country is mandatory.

Thank You

vinaya@itengagements. com