Lead Clinical Research Associate

Company Overview

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in severe liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey. Position Summary:

The Lead/In-house CRA will work with the Clinical Operations team members to assist in overseeing vendors, CROs, and clinical sites participating in clinical studies. The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate, manage, and escalate issues and trends. This is an in-house role that will support the Clinical Operations and cross-functional program team to provide oversight on study related activities.

Roles & Responsibilities:

• Collaborate with the VP, Clinical Operations and wider program team to support and enable clinical study activities in accordance with established protocols.
• Assist in the identification and selection of vendors, including CROs, and provide oversight support in conjunction with relevant CTMs.
• Assist in the identification and selection of Clinical Investigators and sites appropriate to the therapeutic area and phase of the study.
• Work with the CTM to draft, review and approve of study documentation, including essential document packets, study plans, informed consent forms, training materials, etc.
• Attend key team meetings as required; may provide support in cross-functional internal/external study meetings.
• Collaborate with internal departments (regulatory, strategic sourcing, data management etc.) to ensure operational excellence as it relates to study management.
• Implement study tracking, subject enrollment, and site performance metrics in collaboration with CTMs and other Clinical Operations team members.
• Assess, review, and monitor quality and capabilities of partners at our CROs: perform co-monitoring visits as needed, review Monitoring Visit Reports (MVRs) and MVR metrics, assist with site training, etc.
• Evaluate ongoing site performance, review source documents from a sponsor's perspective to ensure compliance with established protocols and quality expectations.
• Review essential documents for IP release and assist with IP inventory tracking.
• Ensure the timely, accurate and complete collection and submission of study data.
• Assist the CROs, vendors, and clinical sites in problem solving and provide consultation on monitoring and other study related activities.
• Demonstrate strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Provide mentorship to internal and external CTAs, CRAs, etc.
• This position may require up to 20% travel

Qualifications:

• 3 or more years of CRA experience, including extensive vendor oversight
• Ex-US trial experience required
• Experience in late-stage clinical trials required (Phase 3 and beyond)
• Working knowledge of GCP, ICH, and relevant regulations required
• Experience with Smartsheets is a plus
• Effective communication (written and verbal), adaptability, and self-motivation are required attributes
• Experience integrating with cross-functional teams such as Regulatory, CMC, Strategic Sourcing, and/or Finance a plus
• Resourceful and able to handle multiple and changing priorities
• Ability to think creatively and independently and be proactive
• Ability to understand team's objectives, identify risks, problem-solve, and escalate in a timely manner
• Ability to exercise discretion when managing confidential information
• Embraces and embodies Boston Pharmaceuticals' corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team
• BA/BS preferred