Associate Clinical Sample Manager - REMOTE (Prefer Local to Rockville, MD)

Orbis Clinical is seeking a remote-based Associate Clinical Sample Manager (Prefer Local to Rockville, MD) for 6 months.

Position Summary

The Contract Associate Clinical Sample Manager (Contractor) assists in clinical trial sample strategy and the effective and transparent management of all clinical trial samples under that plan. This includes assisting in the coordination of all internal and external operational activities required to collect, track, and deliver clinical trial samples for all assigned clinical trials. The Contractor will assist in trial level support via the use of clinical sample management plans, procedures, and tools and will support in management of vendor contracts as applicable. 

Responsibilities:

• Assist with chain-of-custody activities for all specialty assay laboratories using the most appropriate tools (such as sample regimens, LIMS, etc.),
• Support the collection and shipping of clinical samples from investigative sites to centralized locations (and to subsequent locations as applicable) are to plan.
• Assist in setup and periodic review of trial related tools (templates, regimens, rosters, etc.) and reporting capabilities required per clinical sample management plans and procedures.
• Assist in sample management vendor activities as applicable, ensuring all clinical sample related deliverables are in line with the sponsor/laboratory contract and scope of work. This includes support of laboratory vendor manual, tools, as well as monitoring of vendor shipment and receipt activities, planned and actual analyses, study rosters, and sample management related issues.  
• Support incorporating adequate site training and guidance into the clinical trial training plan and all applicable site training materials (e.g. SIV/ IM materials, etc.).
• Assist in the execution and implementation of vendor contracts as needed, in collaboration with applicable clinical and laboratory team members,
• Ensure all required clinical sample deliverables are managed to completion at study closure.
• Assist in providing budget forecasting related to clinical sample management as needed.

Experience and Qualifications

• BA/BS in Health Sciences or relevant discipline.
• 3+ years relevant industry experience.
• 1+ year clinical sample management work experience or equivalent
• Strong knowledge of ICH/GCP guidelines with working knowledge of GLP
• Ability to function in a fast paced, dynamic environment.
• Must be a demonstrated team player with strong interpersonal skills.
• Excellent written and verbal skills.

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $50-$55 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.