Clinical Trial Lead
Denver, CO, USA
Posted on Tuesday, March 14, 2023
Topography Health is a first-of-its-kind, physician-focused clinical trials platform. We offer a full stack of tools and services to empower doctors to gather evidence within an existing practice. Our mission is to accelerate clinical research by increasing the investigative capacity of every physician, creating a new world of medicine where patients have seamless access to advanced research. We care deeply about creating data sets that are more inclusive and representative, and we’re determined to change how research is conducted at the community level. We’re backed by Andreessen Horowitz, Bain Capital Ventures, and other great financial and strategic partners.
As a Clinical Trial Lead at Topography, you will have demonstrated success in a recent clinical research coordinator role and/or a role overseeing CRCs, and be eager for the next step in your career journey. You will execute trials conducted within one or more physician practices and act as day-to-day leader of an ever-growing team, embodying the player/coach philosophy. Our CTLs mentor and train several other on-site staff, and set the tone for an efficient and positive work environment. You will spearhead recruitment and enrollment efforts across our portfolio of active trials with a metrics-driven approach, and conduct patient study visits, which may also include clinical and lab procedures. You will be expected to cover all functions of a successful research program including informed consent, protocol adherence and high data integrity, study start-up, planning, and close-out, PSVs and SIVs, IP management, and protocol deviation tracking to name a few. In your capacity as on-site clinical research expert, you will build trust and relationships with various stakeholders including providers and practice management. Your goals will tie into broader company goals, and be an essential part of our success. The ideal candidate is meticulous, embodies teamwork and self awareness, possesses strong communication skills, and be adaptable to the dynamic clinic and startup environment. You will need to lead with empathy for patients, and as the face of Topography at the local level, a commitment to our mission is a must.
Bachelor’s degree in nursing, public health, life sciences, or other similar field or 4+ years relevant experience
3+ years of experience as a Clinical Research Coordinator and/or Research Assistant, with other similar roles as additional experience
3+ years of experience independently coordinating industry studies, from study startup to close out
Professional working knowledge of FDA regulations and ICH/GCP guidelines
Ability to work 4+ days onsite with remote flexibility
1+ years of prior clinical experience conducting routine procedures (e.g. V/S, EKG, phlebotomy)
1+ years of experience with site-level technologies including EDC, CTMS, or other similar technologies
1+ years experience independently leading/managing a team of clinical research coordinators or similar role
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