Senior Project Specialist

Lexitas

. Provide support to Project Management and other study team members .

Posted 10/21/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical research coordination, project management, and team mentorship, with a strong focus on maintaining documentation and compliance. Proficient in managing project timelines, vendor relationships, and financial reconciliation within a clinical research environment.

Highest-signal resume keywords

Clinical Research CoordinationProject ManagementETMF System ExperienceMentorship and TrainingBudget Tracking and Financial Reconciliation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project Management Plan DraftingRisk Management Plan DraftingETMF MaintenanceCTMS Project-Level Information ManagementBudget TrackingForecastingVendor ManagementCustomer Satisfaction Surveys AdministrationMeeting OrganizationDocumentation Filing

Soft Skills

Attention to DetailGood Communication SkillsCustomer Service OrientationProblem-SolvingOrganizational Skills

Tools & Technologies

MS Office SuiteCTMSETMFEDC SystemsMS Teams

Industry Keywords

Clinical ResearchContract Research Organization (CRO)PharmaceuticalBiotechnologyStudy Start-Up

About the role

Key responsibilities & impact

Provide support to Project Management and other study team members
Keep study-related essential documentation current and filed
Provide expertise in study start-up and overall study coordination
Mentor and train Project Specialists and provide support to more junior CRCs
Serve as a back-up point of contact during Project Manager or Associate Project Manager absences
Set up internal and sponsor team meeting invites, agendas, and minutes, including Kick off Meetings and Investigator Meetings
Set up and maintain CTMS project-level information
Draft project plans, including the Project Management Plan, Risk Management Plan, and eTMF Plan
Draft internal and external project status and progress reports
Oversee project team training and compliance
Draft monthly forecasting and revenue units/activities, including tracking budgets, forecasted hours/visits, and invoicing
Administer Customer Satisfaction surveys through Marketing
Set up and update project timelines with input from the Project Manager
Manage DSMB, DMC, and other committees, including charters, meeting organization, planning, and scheduling
Set up and maintain project-specific MS Teams
Update study items in CTMS, including milestones and study contacts
Liaise with Procurement and confirm vendors are on the approved vendor list
Support vendor setup, contracts, and management activities
Ensure the safety TORO is drafted and the safety database is set up before FPI
Support ancillary supply vendor setup
Review project-level vendor invoices
Review time entry weekly
Assist with completion of the OOS Log
Maintain the Action/Decision Log with input from department leads
Triage new user system access requests and complete user access reviews
Complete final financial reconciliation, including site, vendor, and sponsor invoices and payments
File and maintain study-level documents in the eTMF

Requirements

What you’ll need

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
Customer service oriented
Demonstrated good communication skills (written and verbal)
Attention to detail
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
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
Ability to lift, carry, and move 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

Benefits

Comp & perks

Remote work (United States)