Clinical Operations Specialist

Lexitas

About The Position

Provides support to Study Management and other study team members. Responsible for in-house site management. Manages all protocol-level and investigator-related clinical trial documents, study supplies, and vendor information. Keeps study-related essential documentation current and filed. Facilitates collection and review of essential documents, budgets/contracts, and IRB documentation on behalf of sponsor and site.

Requirements

BA/BS in a science/health care field, nursing degree, or equivalent combination of education and experience
At least 1 to 2 years of clinical research coordinating experience or experience working in a contract research organization (CRO) or pharmaceutical or biotechnology company is preferred
Competent computer skills including MS Office Suite
Customer service oriented
Demonstrates good communication skills (written and verbal)
Attention to detail
Manner of interactions demonstrates an understanding of the value of developing positive relationships
Ability to plan and organize information and activities as directed by a Project Manager or team member
Able to resolve routine problems and elevate issues appropriately
Able to work remotely in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities
Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute

Nice To Haves

Experience working with eTMF and EDC systems is preferred

Responsibilities

Site feasibility process (e.g., questionnaire development, collection, and tracking)
Contribute to creating Study Informed Consent template and route for Clinical Lead and Sponsor review for approval prior to central IRB submission
Complete Local ICF Site and Study Level Checklists and route for Clinical Lead review and approval prior to central IRB submission
Develop other patient-facing materials (e.g., subject diary, questionnaires, etc.)
Prepare and manage central IRB submissions - liaise with central Institutional Review Board (IRB)
Update site-specific information in CTMS
Liaise with the Project Specialist (PS) to draft the site section of the eTMF Plan
Contribute to development of Regulatory Binder Table of Contents and template study logs and forms
Track site activation activities
Collection of regulatory documents from site
Ancillary supply management at the site level, including ordering, reconciliation, re-supply requests, Regulatory Binder contents, and printed materials
Follow up with sites on pending items needed for site activation
Draft and send site activation letter to site upon approval from Clinical Lead
Administer site enrollment surveys
Perform ongoing site file reconciliation
Perform eTMF audits and reviews
Send mass study communications to sites after review and approval from the Clinical Lead
File and maintain all site level documents in the eTMF
Contribute to creating the Monitoring Plan for Clinical Lead review and approval
Provide final EDC subject data to sites with support from the CTA
Provide Site Reconciliation Reports
Run Study User Access Reviews
Perform eTMF document QC
Perform debarment checks on potential Study PIs and record findings in CTMS
Open and close file reviews in eTMF