Senior Project Specialist

Job not on LinkedIn

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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Lexitas

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🛡️ Insurance

💼 Consulting

📦 Logistics

💰 Debt Financing on 2016-09

Insurance • Consulting • Logistics

Lexitas is a trusted provider of legal and corporate support services, offering a wide range of services such as court reporting, record retrieval, legal talent outsourcing, registered agent services, process service, investigations, and eLaw case tracking. The company addresses the needs of legal, insurance, and corporate leaders by delivering responsive professional services combined with advanced technology solutions. Lexitas is dedicated to accuracy, timeliness, and reliability, making it an ideal partner for law firms, insurance companies, and corporations seeking to enhance efficiency and reduce costs in their legal and administrative operations.

📋 Description

• 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

• 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

• Remote work (United States)