What are the responsibilities and job description for the Clinical Lab Scientist I position at IT Engagements, Inc.?
Greetings from IT Engagements IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients. Job Summary
Role: Clinical Lab Scientist I (Contract Role)
Location: Tucson, AZ
Description
vinaya@itengagements. com
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.
- 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)
- 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
- 1-3 years of experience
- Strong problem-solving skills
- Excellent communication abilities
- Knowledge of industry best practices
- Experience in clinical trials preferred
- 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
- 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.
- 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.
vinaya@itengagements. com