Clinical Trial Associate at NSF — Germantown, USA | Base Career

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The Clinical Trial Associate serves as the primary point of contact for administrative support to the site and clinical trial team. The Clinical Trial Associate is also responsible for coordinating the day to day clinical study activities and maintaining the logistical aspects of clinical trials in compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements.

Responsibilities

The Clinical Trial Associate will be involved in most activities in preparation for the set up, conduct, and completion of a clinical trial.

This includes, but is not limited to:

Primary Trial Master File Duties

Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned
Set up and maintain electronic filing systems/set up of the Investigator Site File (ISF)
Track Ethics/Regulatory submissions and approvals for studies
Prepare distribute, track, and file essential clinical trial documentation
Coordinate archiving of study documentation

Cra And Study Team Support

Assist the Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
Serve as the point of contact for CRA assistance with TMF or study related material support
Arrange and participate in the organization of investigator meetings and study team meetings including taking and distributing minutes and tracking of the final document

Assist the Clinical Trial Manager in the site selection process
Assist in initial composition of Operations Manual, Pharmacy Binder, and Investigator Site File (ISF) Binder, etc.
Manage and maintain study documents and trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites
Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial
Create and maintain study contact lists for team/sites/3 rd parties
Review study mailbox and file emails in appropriate mailbox folders
Assist in preparation and distribution of study newsletters /study correspondence to all participating sites on an ongoing basis
Set up of finance systems accurately, process invoices and track payments for the trial for investigator and vendor payments
Assist with collating, tracking and shipping case report forms (CRFs) and data queries to Data Management
General study filing

Other possible tasks may include:

Assist with designing of study logs, source document template, etc.
Arrange translation of advertisement material and patient documents
Assist CRAs on monitoring visits
Reorder clinical drug supplies for sites
Other duties as assigned

#LI-CB1

With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health.

We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide.

We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life.

One of our core values is We Are One NSF.

This means that while we’re one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work.

Come join a team that makes a difference in the world.

More information about NSF can be found at nsf.org.

NSF is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.

Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role.

Resumes submitted to an NSF employee by a third-party agency without a valid written & signed search agreement between NSF and said third-party agency will become the sole property of NSF.

No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral.

Thank you.

Clinical Trial Associate

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Full Job Posting

Responsibilities

Primary Trial Master File Duties

Cra And Study Team Support

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