Clinical Trial Associate/Sr. Clinical Trial Associate

Imbria Pharmaceuticals

3+ years

Not Disclosed

Boston

10 July 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Imbria Pharmaceuticals

Company Overview: Imbria Pharmaceuticals is a privately held clinical-stage company dedicated to developing innovative therapies for patients suffering from cardiometabolic disorders. Our focus is on restoring or enhancing cellular energy production in cardiovascular conditions where energy impairment contributes significantly to symptoms and functional limitations. Our lead investigational product, ninerafaxstat, has successfully completed Phase 2 trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and high-risk patients predisposed to cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). Ninerafaxstat has demonstrated excellent tolerability in Phase 1 and 2 studies, with Phase 2 trial results expected in early 2025 as part of IMPROVE-DiCE.

For more information, visit www.imbria.com.

Position Overview: Clinical Trials Associate (CTA)

Location: Boston area (on-site role)

Responsibilities:

Clinical Operations Support:
- Assist in managing daily clinical operations activities, providing administrative support to study teams.
- Track and maintain trial status to ensure efficient trial management.
Collaboration and Oversight:
- Collaborate with Contract Research Organizations (CROs) and vendors on start-up activities, including site initiation and document review.
- Assist Clinical Trial Manager (CTM) in managing study-specific eTMF (Trial Master File) and other administrative tasks.
Administrative Tasks:
- Develop and review study documents, coordinate team reviews, and distribute study materials.
- Support in building study eSystems and conducting User Acceptance Testing (UAT).
Quality Assurance and Compliance:
- Oversee and conduct quality checks on CRO-managed Trial Master Files.
- Track and reconcile clinical trial equipment, samples, and imaging files.
Financial Oversight:
- Assist in invoice and budget activities, reviewing vendor invoices against contracts under CTM supervision.
Site Management Support:
- Aid CTM in site management activities, including monitoring report reviews and performance metric tracking.
Meeting and Communication Support:
- Plan and organize project-specific meetings, create agendas, record meeting minutes, and distribute documents.
- Act as a point of contact for study-related inquiries from team members and external service providers.
Regulatory Compliance:
- Assist in distributing and tracking IND Safety Reports, SUSARs, and CIOMS reports as per study team procedures.

Qualifications:

Bachelor’s degree in Life Sciences or equivalent field required.
Minimum of 3 years of clinical research experience in biotech, pharmaceuticals, or medical devices.
Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint, SharePoint).
Experience in clinical trial start-up for global studies preferred.
Familiarity with ICG/GCP and FDA regulations governing clinical trials.
Strong ability to work independently, prioritize tasks effectively, and thrive in a fast-paced remote environment.
Excellent communication skills, both verbal and written, with professionalism in all interactions.
Demonstrated commitment to company values, self-motivation, attention to detail, and teamwork.
Focus on continuous improvement, identifying opportunities to enhance operational efficiency.

About Imbria Pharmaceuticals:

Imbria Pharmaceuticals offers a competitive total compensation package and values diversity and innovation in our workforce. Join us in advancing clinical research and making a meaningful impact on patient care. Apply today to build your career with Imbria Pharmaceuticals!

How to Apply:

To apply for the Clinical Trials Associate position at Imbria Pharmaceuticals, please submit your resume and cover letter through our careers page or designated application channel.

Equal Opportunity Employer:

Imbria Pharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, or veteran status.

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