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)
Quest Diagnostics honors our service members and encourages veterans to apply.
While we appreciate and value our staffing partners, we do not accept
unsolicited resumes from agencies. Quest will not be responsible for paying
agency fees for any individual as to whom an agency has sent an unsolicited
resume.
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender
Identity/Religion/National Origin/Disability/Vets or any other legally protected
status.