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 with cardiometabolic heart failure with preserved ejection fraction (HFpEF). 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 and assistance to study teams during study start-up, study execution and close out activities. Key activities include, but are not limited to, review of study specific plans and documents, maintaining study trackers, and oversight of the study-specific eTMF, attending project meetings and managing meeting materials, and assisting with other tasks as assigned.
This is a hybrid position in the Greater Boston area.
Responsibilities
- Serves as a member of the clinical operations team and provides coordination, administrative support and tracking of trial activities to meet project and company goals
- 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)
- Manages 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
- Supports CTM in build of study eSystems and subsequent User Acceptance Testing
- Provides oversight and quality checks of CRO-managed Trial Master File
- Tracks and reconcile clinical trial equipment, samples, imaging files, etc.
- Assists 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 (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, frequently remote working environment
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possesses good interpersonal skills and effective communication with internal and external stakeholders
- 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 process efficiency
The anticipated salary range for candidates who will work in Boston, MA is $75,000 to $95,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
We offer a competitive compensation and benefits package. We invite you to consider a career with Imbria!
