Specialist Study Management - Wilmington, United States - Creative Solutions Services, LLC

Creative Solutions Services, LLC Wilmington, United States

3 weeks ago

Description

Wilmington, DE All On-site Starts 4/22/2024

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Job Description

***Please use the attached/revised ERMO Resume Template for resume submissions*** RECOMMENDED BILL RATE MAX: ***/HR. *You may determine the appropriate pay rate for your candidate; keeping in mind the resulting bill rate should be considered financially responsible according to your existing MSA. If you feel the recommended bill rate is not in line with market demands, please contact me to discuss prior to submitting the candidate. For this open recruitment, please direct communications to main point of contact ***. Thank you

Note: Candidates should be available to start as soon as possible. Start date could change, to an earlier date, depending on when the right candidate has been identified.

Location- Remote (Must be able to work EST time/hours)
Internal AZ Title: Study Start Up Clinical Study Administrator (SSU CSA)

Candidate:

REQUIRED:
1. Strong verbal & written communication skills
2. Strong organizational skills
3. Previous administrative experience
4. Computer proficiency

Key Responsibilities:
SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly
and processed (submitted to vendor or global team) according to study team
guidelines.
SSU CSA is responsible for reviewing and processing all sub Investigator
documents. SSU CSA will attend weekly Study Team meetings to report on vendor
spreadsheets, sub I document progression, etc. All responsibilities are performed
according to AZ Procedural Documents, international guidelines such as ICH and
GCP as well as relevant local regulations.
A SSU CSA with longer tenure and experience may take on additional
responsibilities from the SSU Manager.

Typical Accountabilities
Assist SSU Manager with obtaining and maintaining essential documents in
compliance with ICH-GCP, AZ Procedural Documents.
Review and process start up documents, including Sub Investigators documents in
compliance with ICH-GCP, AZ Procedural Documents
Drive delivery of regulatory documents at the sites. Proactively identify delays in start-
up activities and the risks to the activation plan.
Attend study team meetings and be prepared to provide a report on vendor spreadsheet
status and sub I document status.
Set-up, populate and accurately maintain information in *** tracking and
communication tools (e.g. Veeva Clinical, Box, etc.) and support others in the usage of
these systems

Education, Qualifications, Skills and Experience
Level of education that supports Skills and Capabilities of the position and ensures
successful conduct of accountabilities/responsibilities and appropriate interactions
with internal/external customers, completed high school and further studies in
administration.
Experience with vendor management, strong verbal & written communication skills,
and strong organizational skills
Previous administrative experience
Proven organizational and administrative skills
Computer proficiency
Very good knowledge of spoken and written English
Display excellent organization and time management skills, excellent attention to
detail, and ability to multi-task in a high-volume environment with shifting priorities
Team oriented and flexible; ability to respond quickly to shifting demands and
opportunities

Desirable Qualifications, Skills and Experience
Working knowledge of the Clinical Study Process and an understanding of the range
of working procedures relating to study Start-up, together with an understanding of
the ICH/GCP guidelines
Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
Good interpersonal skills and ability to work in an international team environment
Willingness and ability to train others on study administration procedures
Integrity and high ethical standards

About Artech Information Systems LLC
Artech is the #1 Women-Owned IT Staffing Company in the U.S. working with a workforce of over 11,000 professionals across the globe. We recruit top-notch talent for over 90 Fortune and Government clients with coast-to-coast across the U.S., Canada, India, and China. We empower businesses by providing not just the right solutions and opportunities, but human intellect which makes THE difference.

Our Talent Promise
We enable our team to maximize their intellect by providing unlimited opportunities for growth. Because when theyre empowered, they become achievers in spirit and LIMITLESS at heart.
Empowering your Career. Maximizing your Intelligence.

Our Consultant Care Program
At Artech, we routinely match our best consultants to new assignments. Often, consultants also move on to permanent jobs at our Fortune and Global 500 clients. We manage these transitions with great care because of our long-term dedication to our clients and employees-turned-alumni. Our consultants have Talent Management Specialists (TMS) assigned to them as part of the companys consultant care program. The TMS not only help orient them to their assignment but are there for them if they have any questions or require any additional support.

Connect with us Today
Visit our website to learn more about Artech.
Connect with us on Facebook , LinkedIn , Twitter , and YouTube

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