Clinical Project Support (Hybrid Position)

Job Summary

The Clinical Project Specialist position is responsible for providing general
administrative project management support for the assigned projects.

Essential Functions

• Performs general administrative tasks to support project management activities related to the clinical trial execution, e.g., assist with the development and formatting of documents, review, and reconciliation of study-specific information, etc.
• Supports the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements.
• Assists with document collection, dissemination, tracking and filling as per the organizational process ensuring compliance with SOPs and processes, and all applicable regulations.
• Assists with the development and distribution of site binders as requested.
• Tracks and prepares study-specific information utilizing databases, spreadsheets, and other tools as assigned. This may include but is not limited to clinical and non-clinical supplies and services such as tracking of appropriate subjects and site activity/metrics, performing quality check activities across different components of the clinical trial.
• Sets-up and coordinates meetings, takes and distributes meeting minutes.
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Works closely with study team members and study manager to fulfill assigned study execution tasks.
• Supports study material development as assigned.
• May participate in process improvement and quality-related initiatives associated with study execution and departmental deliverables.
• Other duties as assigned.

Necessary Skills and Abilities

• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required.
• Experience with email and calendar programs necessary.
• Electronic data capture (EDC), CTMS, IVRS, and eTMF experience is preferred.
• Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Excellent communication and interpersonal skills are essential as the CPS interacts with many people of varying levels of responsibility for clinical trial programs.
• Must be able to write clearly and summarize information effectively.
• Must have the ability to build and maintain positive relationships with management and peers.

Educational Requirements

• Bachelor's degree is preferred.
• Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.

Experience Requirements

• 2+ years of experience in the pharmaceutical/clinical research environment is preferred.
• The ideal candidate will have at least 1 year of Clinical Project Specialist experience.