Company Overview
EPM Scientific is partnered with a clinical-stage biopharmaceutical company developing highly engineered targeted therapies for patients with serious liver diseases. Their lead investigational program is gearing up for a large scale Phase 3 trial. They are looking for a Lead/In-House CRA to assist in overseeing vendors, CRO's, and clinical sites. With strong leadership from reputable companies and room for vertical mobility, this is an exciting opportunity to begin working with impactful science.
Roles and Responsibilities
- Collaborate with the VP, Clinical Operations and wider team to support and enable clinical study activities in accordance with established protocols.
- Assist in identification and selection of vendors, including CROs, and provide oversight support in conjunction with relevant CTMs
- Work with the CTM to draft, review, and approve study documentation, including essential document packets, study plans, informed consent forms, training materials, etc.
- Evaluate ongoing site performance, review source documents from a sponsor's perspective to ensure compliance with established protocols and quality expectations.
- Provide mentorship to internal and external CTAs, CRAs, etc.
- Demonstrate strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- 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
