Senior Clinical Research Associate

Senior Clinical Research Associate

Our vision at On Target is to brighten the future for those fighting cancer by making cancer visible intraoperatively so it can be removed more completely with our cancer-targeted intraoperative molecular imaging agents.

We are an agile, tenacious, collaborative biotechnology start-up with a relentless focus on advancing real-time cancer imaging. Our end game is helping people fight cancer, boldly pushing boundaries to advance science, technology, and humanity.

Our intraoperative molecular imaging agents, based on the pioneering work of Purdue University's Philip S. Low, PhD, illuminate cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX (pafolacianine) injection, On Target's first product, received FDA approval for ovarian cancer in November 2021 and lung cancer in December 2022. For more information visit and We are currently commercializing CYTALUX®, and scaling our team.

The Senior Clinical Research Associate (Sr CRA) serves as the primary liaison to clinical trial sites participating in On Target-sponsored studies. This role is responsible for managing site activities across all stages—qualification, initiation, monitoring, and close-out. The Sr CRA ensures patient recruitment, enrollment, and overall site performance are aligned with GCP, ICH guidelines, and company SOPs.

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

UNCONVENTIONAL THINKERS. People who have the courage to challenge the status quo when necessary and come up with a better way of doing things.

RELENTLESS ACHIEVERS. People who thrive in a fast-paced entrepreneurial environment and are creative problem solvers who overcome obstacles with successful solutions.

INSPIRATIONAL COLLABORATORS. People who bring diverse individuals together and build strong teams that can successfully work toward a common goal and achieve success.

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

On Target Laboratories, Inc., is an Equal Opportunity Employer. On Target Laboratories, Inc. does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.