<div><body> OverviewProvides 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<ul style='font-family:"Basel Grotesk",Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;'><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Set up internal and sponsor team meeting invites, create agendas and minutes (including Kick off Meetings and Investigator Meetings) </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">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 </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Draft project status and progress reports internally and externally </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Oversee project team training and compliance </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Draft forecasting and revenue units/activities each month – (tracking budgets, forecasted hours/visits, invoicing) for PM Review</li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Notify Marketing to administer Customer Satisfaction surveys </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Setup and update project timelines with input from the Project Manager </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Manage DSMB, DMC and/or other committee – charters, meeting organization, planning and scheduling</li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Ensure project specific MS Teams is set up and regularly maintained </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Update study items in CTMS (milestones, study contacts, etc) </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Liaison with Procurement and confirm vendors are on the approved vendor list </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Support vendor set up (including vendor contract set up) and management activities </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Ensure the safety TORO is drafted and that the safety database is set up prior to FPI </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Support Ancillary supply vendor set up </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Review project level invoices for vendors </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Weekly review of time entry </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Assist with the completion of the OOS Log </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Maintain Action/Decision Log with input from Department Leads (Clinical Lead, Data Manager, Medical Monitor, Medical Writer, Statistician) </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Triage new user system access requests for new study personnel </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Complete user access reviews </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Perform the final financial reconciliation (including site, vendor, and sponsor invoices and payments) </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">File and maintain all study level documents (protocol, study plans, vendor management, communications, etc) in the eTMF </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Mentor and provide support/training to Project Specialists</li></ul> RequirementsEducation/Experience:<ul style='font-family:"Basel Grotesk",Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;'><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">BA/BS in the science/health care field, or nursing degree, preferred or equivalent combination of education and experience </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">At least 4 years of clinical research coordinating experience or experience working in a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred</li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Competent computer skills including MS Office Suite</li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Experience working with eTMF and EDC systems is preferred </li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;">Capable of performing job responsibilities with minimal training and oversight; sufficient experience and knowledge to serve as a mentor to more junior CRCs </li></ul> 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 RequirementsPosition requires: ordinary ambulatory skills and physical coordination sufficient to move about<s> </s>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.</body></div>

Senior Project Specialist