Project Specialist - Remote

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Project Specialist to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

You’ll be doing:

• Partners with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety).
• Collaborates with the team in the collection of information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases.
• Builds working relationships with the project team to resolve issues at the study level. Collaborate with the cross-functional team to identify risks associated with milestones and deliverables and updates risks on study risk log.
• Applies standard operations procedures (SOPs) and ICH/GCP best practices in all responsibilities assigned.
• Partners with the PM, CL, functional leads (where appropriate) to initiate team communications and documentation internally and externally. Maintain internal and external project team contact lists. Ensures effective communication by scheduling internal and external team meetings, developing agendas, capturing minutes, and managing the action/decision log. Supports the CL in the creation and distribution of study newsletters as required.
• Applies study knowledge to maintain, update, and disseminate study timelines in accordance with the study proposal, as well as feedback from functional groups and the sponsor.
• Partners with the PM in developing, maintaining, and updating financial tools to track project budgets. Helps to identify and track out of scope services, and assists in preparing Change Orders.
• Supports the management of timely approval and tracking of pass-through invoices in accordance with the executed Clinical Trial Agreements. Tracks supplies, invoices, and budgets relating to vendor management, as appropriate.
• Collaborates with the team to ensure assigned projects are audit ready; i.e., project tasks are completed in accordance with project plans (customizes project templates when applicable) and SOPs and are filed to TMF, as appropriate. Initiates TMF development (TMF filing plans, tracking/qc tools, and TMF access); ensure functional group compliance and that the TMF is accurate, complete, and audit ready as all times. Helps to identify and track applicable SOP updates and SOP Deviations at the study level.
• Creates and maintains the required project systems, SOP indices, and study team lists, as applicable. Manages study team/contact lists, system access requests, and e-mail distribution lists as required.
• Collaborates with the functional leads in the development of team trainings or meeting presentations and maintains the study training matrix. Ensures completion and proper documentation of study specific training requirements as directed by the PM.
• Assigned additional project / ad hoc activities to manage independently. Develops and provides training and support to other team members, as appropriate. Leads department improvement activities.
• Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures Participates in corporate initiatives and actions that ensure the continued success of the company.
• Ensures accurate and up to date personal training record.

You’ll need:

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field, or minimum 4 years’ experience in clinical research
• In addition to a Bachelor’s degree or 4 years’ experience in clinical research, 1-3 years of clinical research experience required
• Basic knowledge of ICH/GCP regulations
• Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Basic knowledge of project management terminology and guidelines
• Strong computer skills in MS office suite required