Senior Clinical Trial Associate

Noema Pharma • Boston, MA

1d

About The Position

Noema is developing a late-stage portfolio of oral, small molecule therapeutics with well-characterized mechanisms and distinct features that offer unique therapeutic advantages for neurological and other disorders. The Company is advancing three programs in parallel across orphan and large-market indications, targeting therapeutic areas of high unmet need and limited competition—each with blockbuster potential.
The Senior Clinical Trial Associate supports the execution of clinical studies and/or programs in accordance with CFR, EMA, and ICH GCP regulations. This role is responsible and accountable for providing operational support to assigned clinical study(ies) and for assisting in the coordination and execution of the designated operational activities.
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 SOP’s and internal tracking systems.
To assist project teams with generating or maintaining study specific documentation and guidelines as appropriate.
Assists with TMF maintenance, including submission of documents to and maintenance of TMF documents as part of the Quality Review Process.
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 contacting of clinical sites for specific requests (e.g., enrollment updates, meeting arrangements, etc.).
To organize and attend study team meetings, create agendas and supportive slides/materials, and generate meeting minutes.
To assist the clinical operations and study 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.Contributes actively to assigned project team(s) and other duties as assigned.

Requirements

• BS/BA degree required in science/health-related field preferred, but not required (e.g. High School diploma with 10+ years of experience is acceptable).
• At least 2 years of clinical research experience in clinical trials preferred; 3 or more years to be considered for Senior CTA.
• Experience in phase I-III clinical studies. Global experience a plus.
• 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 and quality.
• eTMF experience (filing, quality checks, etc.).
• Demonstrated experience in study management as well as working with CROs and other study-related vendors.
• Self-motivated and able to thrive working independently and remotely in a fast-paced, innovative small company environment with remote teams while remaining flexible, proactive, resourceful and efficient.
• Pro-active and problem-solving attitude: willing to work hands-on in a very small team with limited internal resources.
• Working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations with an understanding of inspection readiness.
• Open, effective, and proactive written and oral communication skills.
• Proficient using Word, Excel and PowerPoint; Publisher and OneNote are a plus.
• Fluent in spoken and written English, additional languages are an asset.
• If you are local or able to travel to the Boston office at least monthly and travel to study sites or vendors (as needed) and if your profile matches the above description, we look forward to your application.

Nice To Haves

• Global experience a plus.
• Publisher and OneNote are a plus.
• Fluent in spoken and written English, additional languages are an asset.

Responsibilities

• Supports the execution of clinical studies and/or programs in accordance with CFR, EMA, and ICH GCP regulations.
• Provides operational support to assigned clinical study(ies) and for assisting in the coordination and execution of the designated operational activities.
• Assists the Clinical Operations team in completion of all required tasks to meet departmental and project goals.
• Supports the Clinical Operations team with ongoing conduct of studies.
• Be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
• Assists project teams with generating or maintaining study specific documentation and guidelines as appropriate.
• Assists with TMF maintenance, including submission of documents to and maintenance of TMF documents as part of the Quality Review Process.
• Assists in coordinating and tracking of vendor deliverables and progress, creating or maintaining tracking tools and systems.
• Triage incoming correspondence, internal documentation, CRFs, etc., as appropriate, to responsible clinical operations team members.
• Assists in tracking of vendor payments, if applicable.
• Assists in the contacting of clinical sites for specific requests (e.g., enrollment updates, meeting arrangements, etc.).
• Organizes and attends study team meetings, create agendas and supportive slides/materials, and generate meeting minutes.
• Assists the clinical operations and study team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• Assists in the production of slides, etc., as needed for project, departmental, vendor and/or company presentations.
• Contributes actively to assigned project team(s) and other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level