Job Description

Position Overview

This role involves coordinating the timely review of protocol inquiries, adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) data. The position requires tracking data, generating reports, and representing the organization's DSMB/EAC Coordination Team at various committee meetings. Key responsibilities include interfacing with internal and external parties, managing project logistics, preparing contractual documents, and compiling adjudication dossiers.

Employment Type

Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Responsibilities

• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board data.
• Tracks all necessary data and generates reports for the client, project team, and/or external vendors.
• Represents the organization's DSMB/EAC Coordination Team at global and domestic committee meetings (teleconference and face-to-face) with clients, board members, third-party vendors, and the project team.
• Coordinates all logistical aspects and assists with facilitation of meetings.
• Interfaces with various internal and external parties to implement projects.
• Prepares Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements based on contractual considerations.
• Reviews all contractual documents for accuracy and coordinates internal and external approvals.
• Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
• Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals, and distributes them to internal and external project teams.
• Manages project-specific training and the set-up, maintenance, and archival of program files, ensuring PV remains audit-ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites, and escalates reoccurrences to the organization's Data Privacy team.
• Performs data entry into internal/external databases, tracking systems, and the organization's budget management system.
• Performs system reconciliations to identify issues that may negatively impact project timelines.
• Oversees expenses and manages translations, ensuring budget parameters are not exceeded.
• Answers incoming hotline calls and coordinates department functions.
• Performs other duties as assigned.
• Supports any specific activities performed by the local office that cannot be performed from elsewhere.
• Provides training to junior staff.

Qualifications

Education and Experience

• High school diploma or equivalent and relevant formal academic/vocational qualification.
• Technical positions may require a certificate.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Working Conditions and Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Potential drives to site locations and/or travel required on rare occasions.
• Majority of work is computer-based.
• Long and varied hours required on occasion.