Clinical Trial Associate/Sr. Clinical Trial Associate
3 weeks ago
Company Overview
Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit www.imbria.com.
Position Overview
The CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA provides administrative support to study teams throughout the study. Key activities include, but are not limited to, managing meeting materials, review of study documents particularly during study start-up, maintaining study trackers, and oversight of the study-specific eTMF and other administrative upkeep. Note: This position requires the incumbent to reside in the Boston area.
Responsibilities
- Serves as a member of the clinical operations team and provides administrative support and tracking of trial status, with the goal to contribute towards efficient management of trials
- Collaborates with CRO and vendor partners on start-up activities, providing oversight of site initiation, reviewing essential documents, providing authorization of clinical sites to receive investigational product, assisting in providing access to study eSystems, etc., in coordination with Clinical Trial Manager (CTM)
- Administrative upkeep of clinical studies, including development of documents, review, and coordination of broader team review of CRO or vendor-generated material, tracking and distribution of study documents, drafting/review of meeting minutes
- Support CTM in build of study eSystems and subsequent User Acceptance Testing
- Provide oversight and quality checks of CRO-managed Trial Master File
- Track and reconcile clinical trial equipment, samples, imaging files, etc.
- Support invoice and budget activities including review and tracking of vendor invoices against contracts with oversight of CTM
- Assisting CTM with site management activities, including review of monitoring reports, tracking of performance metrics, risk identification and mitigation, etc.
- Provides administrative support to the clinical study team for study related activities (e.g. maintenance of study mailbox, newsletter creation/review, study document formatting, binders, meeting minutes etc.)
- Assists in planning and organizing project-specific meetings including but not limited to internal clinical study team meetings, external service provider/partner meetings, CRA training, Investigator Meeting and PI meetings. Creates agendas, meeting minutes, and distributes.
- May act as point of contact for study-related requests for team members and service providers/partners
- May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan
Qualifications
- Bachelor’s degree required, preferably in the Life Sciences or equivalent
- Minimum of 3 years of clinical research experience or proven competencies for this position, prefer experience in a clinical research related position within the biotech, pharmaceutical or medical device industry
- Must have established experience and fluency in the Microsoft Office package of programs (Excel, Word, Outlook, PowerPoint, SharePoint)
- Prior experience with clinical trial start-up in global studies preferred
- Familiarity with ICG/GCP, and FDA requirements governing clinical trial management
- Proven ability to work independently and prioritize tasks effectively in a fast-paced, remote working environment
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates values and a work ethic consistent with Company Values
- Exhibits high self-motivation, is detail-oriented, and able to work and plan independently as well as in a team environment
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient
This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria
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Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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