Senior Clinical Research Associate, Field Monitor
New
United StatesFull-TimeSenior
SalaryCompetitive base salary with eligibility for discretionary bonus and equity awards
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Job Details
- Experience
- 6+ years of clinical research experience; or equivalent combination of education and experience.
- Required Skills
- GCP
Requirements
- Bachelor’s degree in a clinical research, life sciences, or health-related field.
- 6+ years of clinical research experience or equivalent combination of education and experience.
- Minimum of 2 years’ experience as a Clinical Research Associate II or in a more senior CRA role.
- Strong understanding of clinical trial processes and drug development lifecycle.
- Deep knowledge of GCP (ICH E6) and regulatory requirements (CFR).
- Experience using clinical systems such as EDC, eTMF, and CTMS platforms.
- Excellent communication skills with the ability to explain complex clinical and scientific concepts.
- Strong organizational skills to manage multiple studies, priorities, and deadlines.
- Ability to work independently while also collaborating effectively within cross-functional teams.
- Demonstrated problem-solving skills to identify issues and propose solutions.
- High attention to detail and ability to maintain compliance with SOPs and regulatory standards.
- Willingness and ability to travel up to 75% for on-site monitoring activities.
Responsibilities
- Support the development, review, and distribution of study-related training materials, including site initiation presentations, informed consent templates, and operational manuals.
- Interpret clinical study protocols and provide clear guidance on eligibility criteria, study procedures, scientific rationale, and patient safety considerations to sites and internal teams.
- Serve as a subject matter expert for assigned studies, supporting investigative sites with protocol clarification, feasibility assessments, and operational guidance.
- Oversee site start-up activities, including essential document collection, feasibility questionnaires, and study readiness tracking.
- Participate in data review activities, including CRF review, source document verification support, and resolution of data queries in collaboration with sites.
- Coordinate closely with field CRAs and internal teams to address site issues identified during monitoring visits and ensure corrective actions are implemented.
- Support investigational product (IP) management, including accountability reviews, temperature excursion resolution, and site training on proper handling procedures.
- Conduct remote monitoring tasks and maintain study trackers, metrics, and operational reporting tools.
- Train and support investigators, coordinators, vendors, and newly hired research staff on study requirements and clinical processes.
- Ensure proper specimen handling processes, including review of logs and coordination of shipments to laboratories or vendors.
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