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DIRECTOR OF CLINICAL RESEARCH OPERATIONS

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Posting Details

Posting Details

Reference Number 40-27810
Posted Job Title DIRECTOR OF CLINICAL RESEARCH OPERATIONS
School Name Perelman School of Medicine
Org CC-Cancer Center
Posted to the Web 01/22/2018
Posted Job/Salary Grade 031
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8:00am-5:00pm
Months 12
Position Length Contingent Upon Funding
Position End Date
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Director of Clinical Research Operations implements and oversees operational aspects of research within the Abramson Cancer Center’s Clinical Research Unit (CRU). The incumbent provides regulatory guidance and clinical research support to a diverse group of investigators ensuring compliance with investigator initiated as well as sponsored projects (federal and non federal). This position serves as a Senior Administrative liaison between investigators, clinical research projects and clinical research support staff housed within the disease team units

The Director supports the ACC’s Clinical Research Unit enterprise by:
* Providing advice, counsel and strategic direction to senior research administration and Institutional officials
* Supporting and encouraging new and ongoing clinical research programs
* Raising the level of awareness of the strategic and economic importance of clinical research to internal and external customers
* Interfacing with multiple PENN Medicine Physician Leaders and Administrators at multiple sites to assist with the expansion of the breadth of clinical research across Penn Medicine owned and affiliated entities
* Enhancing the brand of a world-class clinical research program in an NCI -designated comprehensive research center

Clinical Research Management
* Developing and maintain tools, processes, training programs, and standard operating procedures (SOPs) designed to support the conduct of clinical research within the CRU
* Working closely with research administration and physician leadership to strengthen the culture of clinical research.
* Supporting a varied portfolio of clinical research efforts throughout the institution
* Overseeing the provision of services designed to assist the research community with comprehensive and strategic recruitment plans to maximize recruitment efforts for clinical research projects
* Working with established ACC, PSOM and University departments to ensure adherence to protocol and sponsor regulations and safety requirements

Resource Management
* Working with Executive Director of Administration and Physician leadership to identify, justify and utilize requested resources in an efficient manner; assist with presentations to other PENN Medicine officials when required
* Interacting with ACC Business office and disease teams to assists with the oversight of effective and practical budgeting, billing, and monitoring of financial activity for clinical trials.
* Providing leadership to coordinate activities between budgeting and contracting, and financial execution ensuring compliance with sponsored and third party insurance billing.
* Working with ACC business office and Office of Research Billing Compliance to ensure appropriate financial training and distribution of proper communication.

Qualifications
  • MS with at least 7 to 10 years of pharmaceutical industry/Clinical Operations experience, or an equivalent combination of education and experience, required.
    * Requires a minimum of 5 to 7 years of experience in clinical research related activities (e.g., monitor, study coordinator, or similar experience) and a 5-7 year proven record in Clinical Operations activities. An in-depth knowledge and experience in the application of Good Clinical Practice (GCP) regulations is required (e.g., ICH, FDA, NIH/NCI, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is needed.
    * 5 or more years of staff supervisory experience required.
    * Possess strong interpersonal, oral and written communication skills in order to effectively and independently oversee clinical operations and communicate results.
    * Strong ability to demonstrate diplomacy and negotiation skills, as well as the ability to persuade when necessary.
    * Able to confidently interact with all levels of management including senior management, PI’s and others.
    * Ability to develop interdepartmental relationships and form solid collaborations is critical.
    * Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics.
Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Quick Link http://jobs.hr.upenn.edu/postings/34065

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter