Clinical Trials Monitor

Beth Israel Lahey Health•Boston, MA

1d•$58,240 - $90,002•Hybrid

About The Position

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated clinical research studies across all disease groups in the Cancer Clinical Trials Office. The CTM will also help with audit prep by reviewing records for potential FDA or sponsor audits and may be involved in quality improvement and policy. The position is primarily remote but may require some on site work.

Requirements

Bachelor's degree in Life Sciences or related field required; Master's degree in Life Sciences or related field preferred.
1-3 years related work experience required in clinical trials and/or regulatory.
Solid understanding of FDA good clinical practice guidelines
Ability to maintain confidential and sensitive information, set own priorities and work both independently and collaboratively with other research and hospital personnel.
Must demonstrate a positive, professional, and collaborative attitude with peers, supervisors, and colleagues; must possess organization, time management and critical thinking skills.
Advanced skills with Microsoft applications, which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications; may produce complex documents, perform analysis and maintain databases.
Competent in ICH E6 (GCP/GLP/GCLP), ICH Q9, 21 CFR, GDPR and, HIPAA laws and regulations.

Responsibilities

Monitors study facility to assure compliance with GCLP and ICH guidelines.
Conducts detailed review of clinical studies in collaboration with pharmaceutical companies and other sponsors.
Conducts audits of study facility including equipment, documents and procedures to ensure regulatory compliance.
Manages Corrective Action Logs, Deviation Trending Logs, SOPs, GCLP Documents and personnel performance for accurate risk assessment and provides recommendation and oversight on efficiency of research quality.
Ensures study facility inspection preparedness by collaborative efforts across teams and departments as well ensuring GCP/GCLP staff working in designated areas are adequately trained accord to regulatory and SOP standards.
Collaborates with document control team in the development, implementation, and maintenance of SOPs, study protocols and supporting documents.
Reviews clinical trial and non-human primate data ensuring integrity, privacy, consistency and compliance for multiple trials at a time.
Assists as part of the lab administration in the day-to-day functions and activities of the lab, including but not limited to calendar management, ordering, event planning, and other administrative functions as needed
Assists the lab with regulatory filings including, but not limited, to shipping permits and adding personnel to the IACUC animal protocols.
Increases external and internal lab engagement by managing the lab's social media following institutional guidelines, including the center website by creating content, updating news, publications, lab staff profiles, marketing of activities and events.
Other duties as assigned.