On Target Laboratories · 3 hours ago
Senior Clinical Research Associate
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expOn Target Laboratories is a biotechnology start-up focused on advancing cancer imaging technology. The Senior Clinical Research Associate serves as the primary liaison to clinical trial sites, managing site activities across all stages of clinical trials to ensure compliance and performance aligned with guidelines and company standards.
BiotechnologyLife ScienceMedical
Responsibilities
Develop strong site relationships and ensure continuity of site relationships through all phases of the trial
Perform clinical study site monitoring activities in compliance with ICH-GCP, company SOPs, Local Laws & Regulations, Protocol, Study Monitoring Plan and associated documents
Perform remote and on-site monitoring and oversight activities to ensure that data generated at the sites are complete, accurate, and unbiased and that subjects’ rights, safety, and well-being are protected
Conduct site visits including but not limited to evaluation visits, initiation visits, interim monitoring visits, close-out visits
Produce clear and accurate monitoring of visits reports and visit correspondence
Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out
Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance
Identify, assess, and resolve site performance, quality or compliance problems and escalate as appropriate to leadership
Assist with development of study-related documents such as study monitoring plans, informed consent forms, source documents, and/or case report forms
Manage and maintain information and documentation in CTMS, eTMF, and/or various other systems as appropriate and per timelines
Support audit/inspection activities as needed
Manage, monitor, and communicate Investigator Sponsored Study activity to ensure adherence to established timeline
Qualification
Required
Bachelor's degree from an accredited college or university in nursing, healthcare, science, or other appropriate scientific/technical discipline
Minimum of 10 years of clinical research experience, at least 6+ years in a field-based CRA role
Current knowledge of global GCP guidelines and regulations is essential. This job requires a broad knowledge of the global clinical research and drug development process
Willingness to travel up to 80% domestically
Ability to provide operating room case support, including credentialing with multiple credentialing vendors
Experience with Trial Master File (TMF) management according to the DIA Standard Model
Experience operating within various site EMR/HER systems
Experience using eTMF, EDC, CTMS, and other vendor systems/portals
Highly detail oriented with special attention to quality and quality control
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Well organized and able to work under tight deadlines
Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills, including verbal and written communication, are essential
Company
On Target Laboratories
On Target Laboratories engages in discovering, developing, and commercializing small molecules that target specific pathological
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$111.7MKey Investors
Johnson & Johnson InnovationPurdue Foundry Investment Fund
2023-11-16Series C· $30M
2021-03-24Series B· $21M
2018-03-14Series B· $4M
Leadership Team
Scott Huennekens
Executive Chairperson
Recent News
2025-05-04
Google Patent
2025-04-02
2025-04-02
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