Clinical Trials Budgets & Contracts Assistant - Advanced Clinical : Job Details

Clinical Trials Budgets & Contracts Assistant

Fully Remote

6 Month contract with renewal

The Clinical Trials Budgets & Contracts Assistant works closely with study teams, clinical site personnel, Legal, Accounts Payable, and other stakeholders to support logistical and administrative aspects of multiple clinical trials, simultaneously. This position will perform required job duties with oversight from the Budgets & Contracts Senior Manager in compliance with company policies, study protocols, Standard Operations Procedures (SOPs), and applicable legal and regulatory requirements.

● Builds solid working relationships within the Clinical Trial Operations organization

● Provides operational and logistical support for multiple clinical trials/studies or initiative projects, simultaneously

● Prepare site and study related documents such as NDAs and vendor forms

● Work closely with other members of the clinical team, legal, and accounts payable

● Organize, track and manage Study Start-up (SSU) documents (site NDAs, site contracts, vendor set-up)

● Assist with managing study contracts, budgets, vendor set-up and management for clinical trial vendors including investigative sites

● Assists in the preparation, handling, filing, and archiving of clinical documents and reports according to SOPs and study requirements

● Support the department by accurately updating and maintaining clinical systems and trackers to ensure completion of key study activities

● Facilitate internal project communication, correspondence and associated clinical information to external contacts

● Manage tracking and submission of site invoices and payment details, track through payment and reconciliation

● Partner with other research and development groups at Natera to achieve deliverables

● Troubleshoot issues of moderate scope and complexity - Seeks guidance from manager and more senior peers as needed to determine the appropriate course of action

● Demonstrates willingness to expand personal knowledge and commitment to own development

● Day to day tasks are discussed with manager (increasingly independent)

● May suggest process improvements to manager to be considered as development opportunities

● Employee must complete training or provide training records relating to HIPAA/PHI privacy, Humans Subjects Protection, GCP, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. Must maintain a current status.

Qualifications:

● Bachelor's degree or equivalent is required; degree in a scientific related discipline is preferred with 1-2 years of experience working on clinical studies in the biopharma, diagnostics, or medical device fields

Experience with clinical EDC systems

● Familiarity with the organization and structure of the Trial Master File (TMF)

● Competency in SOPs, ICH-GCP, FDA Regulations

● Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint

● Experience in Salesforce, Contract Management and enterprise systems preferred

● Demonstrated ability to work independently

● Outgoing and confident demeanor

● Demonstrated analytical skills and ability to identify problems and propose solutions

● Detail oriented, with solid organization and time management skills