Clinical Trial Study Specialist (Remote)

Job Description

The Clinical Trial Study Specialist is primarily responsible for coordinating the execution of clinical trial projects including working with the Clinical Trial Study Manager to help manage the scope, timeline and budget of assigned projects.

Responsibilities:

• Review contracted scope, budget and timeline to develop a plan of action or multiple plans of action to successfully complete project.
• Coordinate with scientific and technical directors as the scientific leaders for the project.
• Coordinate with appropriate technical staff within the laboratory operations to ensure operational plan is achievable and appropriate resources are available for scope.
• Identify risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available and communicate those to the Clinical Trial Study Manager.
• Identify new or out of scope requests from customer and communicate with Clinical Trial Study Manager so contract modifications can be implemented.
• Maintain official project records from inception to completion including archiving.
• Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).
• Assist Clinical Trial Study Manager in developing overall project plan and maintain regular touch points to ensure that timelines are being met.
• Communicate with customer about discordant samples, shipping and receiving samples
• Tracking, storage, and shipping of samples throughout project lifecycle
• Act as a backup for the project manager during times of absence, leading client communication and management of Quest team.
• Resolve sponsor queries.
• Other duties as assigned.

Qualifications:

Required Work Experience: 

• 1-2 years of healthcare experience or equivalent education and experience.

Preferred Work Experience: 

• Previous work in GXP environment desired.
• Previous laboratory experience preferred.

Physical and Mental Requirements: 

• Ability to sit for extended periods of time.
• Ability to stand for extended periods of time.
• 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.

Skills:

• Excellent verbal and written communication skills. 
• Exceptional interpersonal skills and business acumen.
• Strong organizational skills; very detail oriented and a self-motivated problem solver.
• Ability to multitask and prioritize with little assistance from other staff
• Knowledge of Microsoft Word, Excel, PowerPoint, and Outlook 

Education

• Associates Degree AS Degree & acquire BS within 12 months post-hire. (Required)
• Bachelor’s Degree (Preferred)

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