Senior Clinical Research Associate, Field Monitor in United States at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate, Field Monitor based in United States.
This role is a key clinical operations position within a fast-paced biotechnology environment focused on advancing innovative immunotherapy and oncology treatments. The Senior Clinical Research Associate, Field Monitor will play a critical role in ensuring the successful execution of clinical trials by supporting site operations, interpreting study protocols, and maintaining high-quality data integrity. Acting as a subject matter expert for investigative sites, you will help ensure compliance, patient safety, and protocol adherence across multiple studies. The role involves close collaboration with internal clinical teams, field CRAs, vendors, and site staff to resolve operational and data-related challenges. You will contribute to study start-up, ongoing monitoring activities, and continuous process improvement efforts. This position offers strong exposure to cutting-edge clinical research in a highly collaborative, science-driven environment where your work directly supports the development of life-changing therapies.
- 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.
- Bachelor’s degree in a clinical research, life sciences, or health-related field with 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, drug development lifecycle, and 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 to both technical and non-technical audiences.
- Strong organizational skills with the ability to manage multiple studies, priorities, and deadlines in a fast-paced environment.
- Ability to work independently while also collaborating effectively within cross-functional teams.
- Demonstrated problem-solving skills with the ability to identify issues, propose solutions, and guide site teams accordingly.
- High attention to detail, reliability, and ability to maintain compliance with SOPs and regulatory standards.
- Willingness and ability to travel up to 75% for on-site monitoring activities.
- Competitive base salary with eligibility for discretionary bonus and equity awards
- Comprehensive medical, dental, and vision insurance coverage
- Life, disability, and AD&D insurance options (company-paid and voluntary)
- 401(k) retirement plan with company match
- Flexible spending accounts (healthcare and dependent care)
- Paid time off, including holidays and additional PTO structures based on employment type
- Employee assistance programs and wellness support resources
- Additional perks such as identity theft protection, legal services, pet insurance, and employee discounts
- Flexible remote work arrangement with the ability to support multiple time zones
- Exposure to advanced immunotherapy clinical trials and cutting-edge oncology research programs.