Clinical Trial Study Specialist (Remote)

Quest Diagnostics•West Norriton Township, PA

1d•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 the scope, timeline, and budget of assigned projects. The role coordinates scientific and technical leadership and laboratory operations to ensure project plans are achievable and resources are available. It identifies risks and out-of-scope customer requests, maintains project records, and helps ensure contracted work meets regulatory requirements, including FDA, EMEA, and GCLP requirements. The specialist assists with project planning and timeline tracking, communicates with customers about sample issues and shipping, tracks, stores, and ships samples throughout the project lifecycle, resolves sponsor queries, and serves as a backup for the project manager during absences. Other duties may be assigned.

Requirements

1–2 years of healthcare experience or equivalent education and experience.
Associate of Science degree and obtain a bachelor's degree within 12 months after hire.
Excellent verbal and written communication skills.
Exceptional interpersonal skills and business acumen.
Strong organizational skills, attention to detail, and self-motivated problem-solving ability.
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.
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 who lead the project.
Coordinate with laboratory operations staff to ensure the operational plan is achievable and resources are available for the project scope.
Identify risks that could affect completion of the project scope within the available 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 applicable regulatory requirements, including FDA, EMEA, and GCLP.
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 management of the Quest team.
Resolve sponsor queries.
Perform other duties as assigned.