Job Description: DSMB/EAC Coordinator

Position Overview

The DSMB/EAC Coordinator plays a crucial role in managing and coordinating various aspects of clinical trial data, ensuring timely review, reporting, and adherence to protocols. This position involves significant interaction with internal and external stakeholders, including clients, board members, investigative sites, and third-party vendors.

Employment Type

Full-time

Work Schedule

Standard (Monday-Friday)

Location Type

Office

Environmental Conditions

Office environment with exposure to electrical office equipment.

Responsibilities

• Protocol & Data Coordination:
  • Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) data.
  • Tracks all necessary data and generates reports for clients, project teams, and/or external vendors.
• Meeting Representation & Facilitation:
  • Represents the organization's DSMB/EAC Coordination Team at global and domestic committee meetings (teleconference and face-to-face).
  • Coordinates logistical aspects and assists with facilitation alongside clients, board members, third-party vendors, and project teams.
• Project Implementation & Contract Management:
  • Interfaces with various internal and external parties to implement projects.
  • Prepares Confidentiality Disclosure Agreements (CDAs), Letters of Intent (LOIs), and Member Agreements based on contractual considerations.
  • Reviews all contractual documents for accuracy and coordinates internal and external approvals.
• Dossier Compilation & Site Follow-up:
  • Compiles adjudication dossiers.
  • Creates and submits follow-up information to investigative sites.
• Meeting Management & Documentation:
  • Coordinates and facilitates project meetings.
  • Drafts meeting minutes.
  • Posts blinded and unblinded minutes/materials to client portals and distributes them to internal and external project teams.
• Project File Management & Training:
  • Manages project-specific training.
  • Manages the set-up, maintenance, and archival of program files, ensuring Pharmacovigilance (PV) remains audit-ready.
• Data Privacy & Compliance:
  • Identifies and redacts subject identifiers per local requirements.
  • Retrains sites and escalates reoccurrences to the organization's Data Privacy team.
• Data Entry & Budget Management:
  • 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.
• General Support:
  • Answers incoming hotline calls.
  • Coordinates department functions.
  • Performs other duties as assigned.
  • Supports specific activities performed by the local office that cannot be performed remotely.
  • Provides training to junior staff.

Qualifications

Education and Experience

• High school diploma or equivalent, along with a relevant formal academic or 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.
• Potential drives to site locations and/or rare travel may be required.
• The majority of work is computer-based.
• Long and varied hours may be required on occasion.