1+ months

Director of Clinical Research Ops

Kelly Services
Denver, CO 80238
**Director of Clinical Research Operations**

**Direct Hire**

(Full Benefits)


The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.


In collaboration with the Associate Director of Clinical Research and the Director for the Oncology Clinical Research Support Team, this position will ensure that the functions of the CDPM are carried out, in particular by providing oversight and coordination for clinical trial activity conducted by the Cancer Center, focusing on the CCTO which conducts clinical trials. This position will also oversee education and training for clinical research staff and work in collaboration with the Director for the Oncology Clinical Research Support Team to develop standard operating procedures related to oncology clinical research.


+ Optimize clinical program results by improving CCTO administrative, operational and financial performance related to clinical research and resolving problems through the independent exercise of judgement and discretionary decision-making authority.

+ Develop and strengthen resources, programs and services that facilitate clinical research operations within the CCTO with a continuing focus on quality improvement, cost-effectiveness and productivity enhancement.

+ Participates in the strategic decision-making process relevant to clinical research through leadership as a member of the Clinical Research Leadership Team.

+ Evaluates and coordinates improvements in processes to maintain performance.

+ In collaboration with the CCTO management, provides leadership, and oversight for operations of the CCTO by coordinating across functions (pre-award budget development, contract routing, regulatory submission, trial implementation, etc) and systems (clinical trial management system, reporting systems, etc) to optimize the trial process.

+ Collaborates with the Assistant Director of Finance in developing accurate projections of expenses, budgetary, and staffing needs and makes recommendations to CCTO management and the CCTO Medical Director as appropriate.

+ Works with the CCTO managers and the Cancer Center Assistant Director of Finance to develop metrics to support resource allocation decisions and develop annual budget requests.

+ Establishes and maintains communication and collaboration with the Director of Research Compliance, the Vice Chancellor for Research and the Oncology Clinical Research Support Team (OCRST) Director regarding issues relevant to patients participating in clinical trials conducted across the Cancer Center.

+ Holds joint responsibility with the OCRST Director for the development and implementation of Cancer Center guidelines and policies.

+ Leads, together with the Cancer Center Associate Director of Clinical Research, and the Director of OCRST, the efforts to achieve clinical research administration goals as delineated in the Cancer Center Support Grant (P30), including participating in the writing and editing of relevant sections of the grant and annual progress reports, and participation in the NCI site visit.

+ Develops effective partnerships with the Clinical Research Administration Office (CRAO), OnCore team, CCTSI (CTSA-grant holder), Investigation Drug Service, and Health administration among others.

+ Establishes a collaborative working environment with member institutions under the Health system and communicates with Associate Director of Clinical Research, CCTO Medical Director and Leadership team regarding all issues related to research.


**Minimum Requirements** **:**

+ A bachelors degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.

The position requires 7+ years of extensive, diverse and progressively responsible clinical oncology research experience, including direct responsibility for operations and /or organization management.

**Substitution:** A combination of education and related technical/professional experience may be substituted for the bachelors degree on a year for year basis. A masters degree in a related field can substitute for the bachelors degree.

+ The position requires extensive, diverse and progressively responsible clinical research experience, including direct responsibility for operations and /or organization management. 7+ years of experience with at least 3 years oncology experience required.

**Preferred Qualifications** **:**

+ Masters degree in a health, science or business field

+ Experience working in an academic institution

+ Experience writing policies and procedures

+ Experience with research budget and grant development for sponsored projects

+ Experience with OnCore Clinical Trial Management System

**Knowledge, Skills and Abilities** **:**

+ Ability to lead through collaboration and teamwork.

+ Ability to optimize clinical research operational results by promoting and supporting a positive internal and external customer service focus throughout the Cancer Center.

+ Advanced knowledge of Good Clinical Practices, FDA rules and regulations in relation to clinical trials, and ICH regulations.

+ Excellent interpersonal communication, organization skills, and ability to problem solve and manage a fast-paced highly diverse workload.

+ Knowledge of academic center regulatory and clinical processes as related to clinical trials.

Contact cynthia.silva@kellyscientific or 303-229-2032 for more information

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2022-04-11 Expires: 2022-06-11

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Director of Clinical Research Ops

Kelly Services
Denver, CO 80238

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