Clinical Research Associate; In-House Burlington, MA

l be a key enabler of clinical sites’ success with respect to study enrollment, site relationships, data integrity and overall quality.

Responsibilities include a focus on investigators, regulations, compliance, timelines, data collection and review, and safety reporting. The In-house Sr. CRA may be assigned to 1-2 projects, with flexibility to assume additional project assignments. This position is an excellent opportunity for career development as MBX builds out the infrastructure to support our clinical pipeline.
Key Responsibilities
• Acts as primary liaison for assigned study sites, CROs and Vendors to convey project information, answer questions and resolve issues in accordance with the CTM escalation pathway.
• Develops and reviews regulatory documentation to support study start-up activities, including ensuring all site supplies are available on site for site initiation visits.
• Attends, prepares and presents materials for Investigator Meetings and study-specific training for assigned trials when needed.
• Conducts all operational responsibilities in compliance with applicable Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.
• Involved in the independent completion of activities across multiple clinical studies, ensuring the safety of the subjects and the integrity and validity of the study data are maintained.
• Ensures all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials in collaboration with the CTM.
• Conducts and oversees all phases of study monitoring (PSV, SIV, IMV, and COV), either independently or jointly with a CRO partner.
• Oversees subject recruitment and treatment status remotely through IxRS and EDC systems and direct communication with sites to update detailed tracking sheets daily.
• Oversees various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.) and follows up to collect outstanding documents.
• Maintains current understanding of assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials.
• Contributes to the study budget process by managing and reconciling invoices for 3rd party CROs, vendors, consultants and clinical sites.
• Partners with the CTM for overall project management of trials including preparing meeting agenda, minutes, and action items.
• Identifies new approaches to resolve problems and mitigate risks.
• Serves as mentor for junior CRAs and CTAs and those new to the company and/or clinical trial management.
• Adheres to all department and company-wide policies regarding conduct, performance, and procedures.
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. Responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising, and managing job performance, delivering feedback, coaching, and providing career development planning and opportunities.
• Performs other duties as required.
Education
• Bachelor’s degree with 5+ years related experience.
Experience
• 4+ years of direct experience with clinical site management, CRO/Vendor management, and logistical execution of clinical trials.
• Experience working in a small company in the biotech or pharmaceutical industry is preferred.
• Prior team management experience (direct or indirect).
• Experience with Smartsheet and Veeva Vault eTMF systems.
• Strong understanding of clinical trials, drug development, Phase I through Phase III.
Additional

Skills and Qualifications
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Ability to establish and…