Client Delivery Analyst (Clinical Trials Coordinator)- Lewisville, TX req58670 in Lewisville, TX at Quest Diagnostics

Date Posted: 2/12/2021

Job Snapshot

Job Description

Client Delivery Analyst (Clinical Trials Coordinator- Lewisville, Texas - Mon-Fri Day shift

Job Summary:
The Client Delivery Analyst is primarily responsible for coordinating and assisting the execution of clinical trial projects including managing the scope, timeline, and budget of assigned projects. This position will manage monthly reports, sponsor communications, departmental SOPs, and maintain regulatory documentation including facilitation of sponsor qualification questionnaires. In addition, this position will also actively participate as a laboratory medical technologist and support the laboratory personnel on various studies as needed.

Essential Duties and Responsibilities:
-Review contracted scope, assist with budgets, 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.
-Coordinate with the Operations Manager throughout the life of the project to ensure scope, timeline and budget are well understood and understand escalation path for communicating issues.
-Identify, track, and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.
-Identify new or out of scope requests from customer and communicate with Operations 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).
-Develop overall project plan and maintain regular touch points to ensure that timelines are being met.
-Communicate with customer on regular operational items (project updates, scope alignment).
-Other duties as assigned.
-Ensures quality of performance in accordance with internal policies and contract parameters
-Ensures compliance with CLIA, HIPAA, GCP, OSHA, and safety guidelines as described in the respective regulations.

Works closely with the Operations Manager and Lead Technologist to maintain QA/QC and compliance within the department

Essential 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.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to read, analyze, and interpret documents such as scientific and technical journals, safety rules, operating and maintenance instructions, and procedure manuals
Basic mathematical skills required

Experience and Education:
-Bachelor’s degree in Science or equivalent
-MLS(ASCP) certification or 3-4 years of clinical laboratory experience.
-1-2 years of previous project management experience required.
-1-2 years of previous laboratory experience preferred.

Physical & 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.

Work Environment:
The work environment characteristics described herein are representative of those an employee encounters while performing the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Exposure to inside environmental conditions; brief exposure to refrigerator and freezer temperatures.
Exposure to minimal but constant noise levels.
Frequent exposure to hazards with:
Automation - proximity to moving mechanical parts.
Electrical currents associated with testing equipment.
Fumes, odors and/or gases associated with chemicals, reagents, and/or microbial cultures.
Exposure to biohazards associated with the handling of patient specimens
Exposure to radioactive materials
Note: Most functions require the use of personal protective equipment such as face shields, gloves, and fluid resistant coats.

Other Requirements:
Travel (0 – 10%) Occasional travel required to meet with customers or attend trade shows or
Occasional weekends

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