Clinical Trial Associate

NSF•Germantown, MD

About The Position

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.

Requirements

Bachelor’s degree (or equivalent) in scientific discipline
1 year of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience).
Working knowledge of ICH-GCP guidelines and FDA regulations
Strong verbal and written communication skills
Ability to work effectively both independently and in a team environment
Strong organizational and planning skills
Excellent interpersonal and professional skills
Excellent time management skills with the ability to prioritize responsibilities and multitask
Strong administrative skills
Excellent documentation and file management skills
Self motivated and detail oriented
Proficient in Microsoft Office and able to learn appropriate software

Nice To Haves

Prior experience in clinical research is preferred.

Responsibilities

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
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/3rd 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
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