University of Pennsylvania ASSOCIATE DIRECTOR OF OPERATIONS in Philadelphia, Pennsylvania
ASSOCIATE DIRECTOR OF OPERATIONS Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.
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Reference Number 40-28931
Posted Job Title ASSOCIATE DIRECTOR OF OPERATIONS
School Name Perelman School of Medicine
Org CC-Cancer Center
Posted to the Web 06/11/2018
Posted Job/Salary Grade 030
Employment Type Exempt
Position Type Full Time
Position Schedule 8am-5pm
Position Length Contingent Upon Funding
Position End Date
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.
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/
Reporting to the Director of Clinical Research Operations (DCRO) for the Abramson Cancer Center(ACC)- Clinical Research Unit (CRU), the Associate Director of Operations (AD-OP) will be responsible for the frontline direction and planning for day to day clinical research operations. The AP-OP will oversee all operational aspects of the research being performed within the CRU. The AD-OP must have a comprehensive understanding of clinical trial processes and the conduct of clinical research studies. The AD-OP will provide oversight of the daily CRU operations that is aligned with ICH Good Clinical Practice (GCP) to ensure that all staff adhere to the requirements of the University of Pennsylvania and all applicable regulatory bodies.The AD-OP will serve as the day to day CRU operations lead for the ACC CRU physician lead investigators, clinical research staff, and collaborative health system departments.* The AD-OP will directly manage and supervise the CRU Central Operations staff including the Biospecimen Manager, the Multi-Site Project Manager, Float staff (Clinical Research Nurses and Research Assistants). This includes responsibility for performance management and overseeing hiring. * The CRU Research Team managers (Program Managers and Lead Research Nurses) will report indirectly to the AD-OP (with primary reporting to the Physician Leaders of their teams).* The AD-OP will assess the need for additional staff for the CRU and develop plans for hiring additional staff as needed in conjunction with the CRU Research Team Managers and Physician Leaders, the CRU DCRO, and the CRU Medical Director.* The AD-OP will serve as the primary operations liaison for internal collaborative departments including the University of Pennsylvania’s Infusion/CHPS Suite, Pharmacy/IDS, Laboratory/Biospecimens, Radiology/RECIST Core, and ACC clinical practice leaders.* In conjunction with the Associate Director for Education and Quality Assurance (AD-EDUC & QA), the AD-OP will develop a program to continually assess protocol compliance and data quality across the CRU Research Teams and prepare reports for the CRU DCOM, CRU Medical Director, and the Lead Physician Investigator for each team. * Work collaboratively with the Program Managers to identify resource requirements for upcoming protocols, forecast logistical issues impacting operations, and ensure smooth transition of protocols from startup, to study activation, to study close out. This includes study selection and prioritization of work. * In collaboration with the CRU Associate Directors of Regulatory Affairs (AD-RA), AD-EDUC & QA and the DCRO, the AD-OP will facilitate the flow of new ACC CRU research studies through the study life cycle, by identifying operational obstacles and propose improvements to the process. * Collaborate with the AD-RA, the AD-EDUC & QA, the DCRO and the CRU Medical Director with unit-wide process improvements. Develop operational process improvements and tools to ensure adherence to standard operating procedures, GCP, and requirements of all applicable regulatory bodies, increase unit efficiency, and reduce errors.* Participate in research team meetings, Research Team meetings, and ongoing protocol training/compliance meetings. * Interview candidates, check references and make hiring recommendations to Research Teams as requested.
The minimum of a Bachelor’s degree and 7 years to 10 years of experience in health administration or related field, or an equivalent combination of education and experience, required. Master’s degree preferred. Training and experience in clinical research or clinical research compliance healthcare required. At least 5 years’ experience in a hospital academic medical setting or pharma with principle responsibilities related to clinical research and or research education preferred. Oncology experience and prior leadership experience preferred. Able to confidently interact with all levels of management including senior management, physician leaders and others. Must be detail oriented and organized. Excellent verbal/written communication skills required. Prior experience in developing policy or procedural documentation, and/or SOP is required. Excellent technical writing, review, and analytical abilities; Excellent interpersonal and multi-tasking skills. Ability to work collaboratively on all levels and to gain support of others. Ability to develop interdepartmental relationships and form solid collaborations is critical. 5+ years of Good Clinical Practices (GCP) related experience required; Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired. Strong MS Office skills.
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.
Quick Link http://jobs.hr.upenn.edu/postings/37583
Posting Supplemental Questions
Required fields are indicated with an asterisk (*).
How did you hear about this employment opportunity?
Contacted by a Penn Recruiter
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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
PHD/MD/JD or equivalent doctoral degree
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
Do you possess a BA degree and at least 7-10 years experience in health administration or related field?
Do you possess a Master degree and at least 5-7 years experience in a health administration or related field?
Do you have a comprehensive understanding of clinical trial processes and the conduct of clinical research studies?
Do you have at least 5 years’ experience in a hospital academic medical setting or pharma with principle responsibilities related to clinical research and or research education?
Do you have at least 3-5 years of experience managing or directing people?
Do you have a thorough knowledge of relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines ?
Do you have knowledge of funding policies, NIH, and other grant procedures ?
Do you have any oncology experience?
Do you have experience interacting with officials at higher levels?
Do you have strong Microsoft program skills?
- Cover Letter