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.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.