Senior Project Specialist

Lexitas

18h

About The Position

The Senior Project Specialist supports Project Management and other study team members by maintaining current study-essential documentation and providing expertise in study start-up and overall study coordination. The role applies and adapts knowledge from previous experience to new study situations, mentors and trains Project Specialists, and may serve as a back-up point of contact when a Project Manager or Associate Project Manager is absent. The position coordinates project administration, documentation, timelines, meetings, training and compliance, vendor activities, financial tracking, system access, and study-level filing. It also supports project planning and reporting, committee coordination, safety-system readiness, and final financial reconciliation.

Requirements

A BA/BS in a science or health care field, a nursing degree, or an equivalent combination of education and experience; the listed degree paths are preferred.
At least 4 years of clinical research coordinating experience, or experience working in a CRO, pharmaceutical, or biotechnology company, is preferred.
Competent computer skills, including use of the MS Office Suite.
Able to perform job responsibilities with minimal training and oversight and has sufficient experience and knowledge to mentor more junior CRCs.
Customer-service orientation.
Demonstrated good written and verbal communication skills.
Attention to detail.
Interactions that demonstrate 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.
Ability to resolve routine problems and elevate issues appropriately.

Nice To Haves

A BA/BS in a science or health care field or a nursing degree.
At least 4 years of clinical research coordinating experience or experience in a CRO, pharmaceutical, or biotechnology company.
Experience working with eTMF and EDC systems.

Responsibilities

Set up internal and sponsor team meeting invitations, agendas, and minutes, including Kick-off and Investigator Meetings.
Set up and maintain project-level information in CTMS.
Draft the Project Management Plan, Risk Management Plan, eTMF Plan, and other project plans for Project Manager review.
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 and visits, and invoicing, for Project Manager review.
Notify Marketing to administer Customer Satisfaction surveys.
Set up and update project timelines with input from the Project Manager.
Manage DSMB, DMC, and/or other committees, including charters, meeting organization, planning, and scheduling.
Ensure the project-specific MS Teams site is set up and regularly maintained.
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, including vendor contract setup, and vendor management activities.
Ensure the safety TORO is drafted and the safety database is set up prior to 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, including the Clinical Lead, Data Manager, Medical Monitor, Medical Writer, and Statistician.
Triage new user system-access requests for new study personnel.
Complete user-access reviews.
Perform final financial reconciliation, including site, vendor, and sponsor invoices and payments.
File and maintain all study-level documents, including protocols, study plans, vendor management documents, and communications, in the eTMF.
Mentor and provide support and training to Project Specialists.