Clinical Trial Study Specialist (Remote)
About The Position
The Clinical Trial Study Specialist coordinates the execution of clinical trial projects and works with the Clinical Trial Study Manager to help manage project scope, timelines, and budgets. The role coordinates with scientific and technical directors and laboratory operations staff to develop achievable operational plans and ensure appropriate resources are available. It identifies and communicates project risks and out-of-scope customer requests, maintains official project records through archiving, and helps ensure work complies with FDA, EMEA, and GCLP requirements. The specialist also helps develop and monitor project plans, communicates with customers about discordant samples and sample shipping and receiving, and tracks, stores, and ships samples throughout the project lifecycle. When the project manager is absent, the specialist serves as a backup by leading client communications and managing the Quest team, and resolves sponsor queries.
Requirements
- 1–2 years of healthcare experience or equivalent education and experience.
- Associate degree required, with an AS degree holder required to acquire a BS within 12 months post-hire.
- Excellent verbal and written communication skills.
- Exceptional interpersonal skills and business acumen.
- Strong organizational skills, attention to detail, and a self-motivated problem-solving approach.
- Ability to multitask and prioritize with little assistance from other staff.
- Knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to sit and stand for extended periods.
- Must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Ability to use fine motor skills to operate office equipment.
- Ability to receive and comprehend instructions verbally and/or in writing.
- Ability to use logical reasoning for simple and complex problem solving.
Nice To Haves
- Previous work in a GXP environment.
- Previous laboratory experience.
- Bachelor’s degree.
Responsibilities
- Review contracted scope, budget, and timeline and develop one or more plans of action to complete the project successfully.
- Coordinate with scientific and technical directors as project scientific leaders.
- Coordinate with laboratory operations staff to ensure the operational plan is achievable and appropriate resources are available.
- Identify risks that could affect project scope, timeline, or budget, and communicate them to the Clinical Trial Study Manager.
- Identify new or out-of-scope customer requests and communicate them to the Clinical Trial Study Manager so contract modifications can be implemented.
- Maintain official project records from inception through completion, including archiving.
- Ensure contracted work is conducted in accordance with FDA, EMEA, and GCLP regulatory requirements.
- Assist the Clinical Trial Study Manager in developing the overall project plan and maintain regular touch points to ensure timelines are met.
- Communicate with customers about discordant samples and sample shipping and receiving.
- Track, store, and ship samples throughout the project lifecycle.
- Back up the project manager during absences by leading client communication and managing the Quest team.
- Resolve sponsor queries.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Education Level
Associate degree
