Job Description
The Clinical Project Specialist provides general administrative project management support for the assigned projects.
· Perform 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.
· Assist with document collection, dissemination, tracking and filling as per the organizational process ensuring compliance with SOPs and processes, and all applicable regulations.
· Assist with the development and distribution of site binders as requested.
· Track and prepare 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.
· Set-up and coordinate meetings, take and distribute meeting minutes.
· Proactively identify and escalate issues that arise relate to support functional deliverables.
· Work closely with study team members and study manger to fulfill assigned study execution tasks.
· Support study material development as assigned.
· May participate in process improvement and quality-related initiatives associate with study execution and departmental deliverables.
· Other duties as assigned.
Qualifications
· 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.
· 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.
· 2+ years of experience in the pharmaceutical/clinical research environment is preferred. Ideal candidate will have at least 1 year of Clinical Project Specialist experience.
· 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.
Additional Information