Specialist Study Management

1 week ago

Wilmington, United States Artech Full time

***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 Investigator s 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 #J-18808-Ljbffr

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