Clinical Trial Associate

Noema Pharma is a clinicalstage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.

At Noema Pharma every patient matters.

Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes.

We partner with patients their families and caregivers and healthcare professionals to provide a comprehensive approach that goes beyond treating symptoms to ensure that patients experiences perspectives needs and priorities are meaningfully incorporated into our work.

Tasks

Position Summary:

• Assists in the provision of study and/or program execution to plan in accordance with CFR EMA and ICH GCP regulations.
• Responsible and accountable for supporting assigned clinical study(ies) and assisting in the coordination/execution of assigned operational aspects.

Responsibilities:

• To assist the Clinical Operations team in completion of all required tasks to meet departmental and project goals.
• To support the Clinical Operations team with ongoing conduct of studies.
• To be familiar with ICH GCP appropriate regulations relevant SOPs and internal tracking systems.
• To assist project teams with generating or maintaining study specific documentation and guidelines as appropriate.
• To set up organize and maintain with quality all clinical study documentation (e.g. Trial Master File) provide oversight and quality during maintenance through to final reconciliation and archival.
• To assist in coordinating and tracking of vendor deliverables and progress creating or maintaining tracking tools and systems
• To triage incoming correspondence internal documentation CRFs etc. as appropriate to responsible clinical operations team members.
• To assist in tracking of vendor payments if applicable.
• To assist in the contact clinical sites for specific requests (e.g. enrollment updates meeting arrangements etc.).
• To attend project team meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination activities preparation and generate meeting minutes.
• To assist in the production of slides etc. as needed for project departmental vendor and/or company presentations.
• Other duties as assigned.

Requirements

• BS/BA degree required in science/healthrelated field preferred but not required.
• 2 years of clinical research experience in clinical trials preferred.
• General understanding of the drug development process to assist in the management of deliverables as assigned.
• Ability to manage and organize multiple priorities while maintaining attention to detail.
• Selfmotivation and able to work independently in a fastpaced small company environment.
• Proactive and problemsolving attitude: willing to work handson in a very small team with limited internal resources.
• Strong work ethics.
• Personal resilience perseverance energy and drive.
• Working knowledge of ICH GCP guidelines CFR EMA and HIPAA regulations.
• Open effective and proactive written and oral communication skills.
• Fluent in spoken and written English additional languages are an asset.

We are looking for a person who lives in the Boston / New York region.