Senior Project Specialist

Overview

Provides support to Project Management and other study team members. Keeps study-related essential documentation current and filed. Provides expertise in study start-up and overall study coordination, integrating and adapting knowledge from past experience to fit new study situations. Mentors and trains Project Specialists (PSs) and may serve as a back-up point of contact in Project Manager or Associate Project Manager absences.

Responsibilities

• Set up internal and sponsor team meeting invites, create agendas and minutes (including Kick off Meetings and Investigator Meetings)
• CTMS set-up and maintenance of project-level information Draft Project Management Plan (PMP), Risk Management Plan (RMP), eTMF Plan and other project plans as needed for PM review
• Draft project status and progress reports internally and externally
• Oversee project team training and compliance
• Draft forecasting and revenue units/activities each month – (tracking budgets, forecasted hours/visits, invoicing) for PM Review
• Notify Marketing to administer Customer Satisfaction surveys
• Setup and update project timelines with input from the Project Manager
• Manage DSMB, DMC and/or other committee – charters, meeting organization, planning and scheduling
• Ensure project specific MS Teams is set up and regularly maintained
• Update study items in CTMS (milestones, study contacts, etc)
• Liaison with Procurement and confirm vendors are on the approved vendor list
• Support vendor set up (including vendor contract set up) and management activities
• Ensure the safety TORO is drafted and that the safety database is set up prior to FPI
• Support Ancillary supply vendor set up
• Review project level invoices for vendors
• Weekly review of time entry
• Assist with the completion of the OOS Log
• Maintain Action/Decision Log with input from Department Leads (Clinical Lead, Data Manager, Medical Monitor, Medical Writer, Statistician)
• Triage new user system access requests for new study personnel
• Complete user access reviews
• Perform the final financial reconciliation (including site, vendor, and sponsor invoices and payments)
• File and maintain all study level documents (protocol, study plans, vendor management, communications, etc) in the eTMF
• Mentor and provide support/training to Project Specialists

Requirements

Education/Experience

• BA/BS in the science/health care field, or nursing degree, preferred or equivalent combination of education and experience
• At least 4 years of clinical research coordinating experience or experience working in a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred
• Competent computer skills including MS Office Suite
• Experience working with eTMF and EDC systems is preferred
• Capable of performing job responsibilities with minimal training and oversight; sufficient experience and knowledge to serve as a mentor to more junior CRCs

Skills

• Customer service oriented
• Demonstrated good communication skills (written and verbal)
• Attention to detail
• Manner of interactions demonstrates an understanding of the value of developing positive relationships
• Ability to plan and organize information and activities as directed by a Study Manager or team member
• Able to resolve routine problems and elevate issues appropriately

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.