Senior Project Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide assistance to Project Management and other members of the study team.

• Maintain essential study documentation, ensuring it is up-to-date and properly filed.

• Offer expertise in study initiation and overall study coordination.

• Mentor and train Project Specialists while supporting junior Clinical Research Coordinators (CRCs).

• Act as a backup point of contact during the absence of the Project Manager or Associate Project Manager.

• Organize internal and sponsor team meeting invites, agendas, and minutes, including Kick-off and Investigator Meetings.

• Establish and maintain CTMS project-level information.

• Draft project plans such as the Project Management Plan, Risk Management Plan, and eTMF Plan.

• Prepare internal and external project status and progress reports.

• Oversee training and compliance for the project team.

• Prepare monthly forecasts and track revenue units/activities, including budgets, forecasted hours/visits, and invoicing.

• Manage Customer Satisfaction surveys via Marketing.

• Create and update project timelines based on input from the Project Manager.

• Coordinate DSMB, DMC, and other committee activities, including charters, meeting organization, planning, and scheduling.

• Set up and manage project-specific MS Teams.

• Update study information in CTMS, including milestones and study contacts.

• Collaborate with Procurement to ensure vendors are on the approved vendor list.

• Assist with vendor setup, contracts, and management activities.

• Ensure the safety TORO is drafted and the safety database is established prior to FPI.

• Facilitate ancillary supply vendor setup.

• Review project-level vendor invoices.

• Conduct weekly time entry reviews.

• Help complete the OOS Log.

• Maintain the Action/Decision Log with input from departmental leads.

• Manage new user system access requests and conduct user access reviews.

• Finalize financial reconciliation, including site, vendor, and sponsor invoices and payments.

• Organize and maintain study-level documents within the eTMF.

⛳️ Requirements

• BA/BS in a science/health care field or nursing degree preferred, or an equivalent combination of education and experience.

• A minimum of 4 years of clinical research coordinating experience or experience in a contract research organization (CRO), pharmaceutical, or biotechnology setting is preferred.

• Proficient computer skills, including the MS Office Suite.

• Experience with eTMF and EDC systems is preferred.

• Capable of performing job responsibilities with minimal supervision; possesses sufficient experience and knowledge to mentor junior CRCs.

• Customer service-oriented.

• Strong communication skills, both written and verbal.

• Keen attention to detail.

• Ability to organize and plan information and activities as directed by a Study Manager or team member.

• Capable of resolving routine problems and appropriately escalating issues.

• Adequate ambulatory skills and physical coordination to navigate conference or meeting locations as necessary.

• Ability to stand, walk, stoop, kneel, and crouch periodically for extended durations.

• Capacity to lift, carry, and move light to medium weights ranging from 10–35 pounds.

• Dexterity in arms, hands, and fingers, including the ability to grasp and type for extended periods.

• Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials over prolonged periods.

• Ability to sit, reach with hands and arms, talk, and hear for extended durations.

🏝️ Benefits

• Remote work (United States).