Summary
Full time 8-5 M-F. No weekends/holidays. Not remote.
Job Description
POSITION SUMMARY:
Cancer research is an essential component of high quality cancer care. The administrative, financial and regulatory complexities necessary to provide safe, compliant, and relevant broad scale cancer research require dedicated and experienced leadership. The Administrative Director of Cancer Research and ABBCI CRU is a position based at Penn Medicine’s nationally recognized Ann B. Barshinger Cancer Institute and works in a dyad relationship with the medical director of cancer research. Working through multiple stakeholders and matrix relationships, this role will have strategic and tactical oversight of CRU business development, contracting and budgeting, regulatory compliance, process effectiveness and functionality, and team development. This key strategic leader will also represent the business and administrative needs of the ABBCI CRU at the LGH Research Institute and the Penn Cancer System level.
ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
Responsible for working collaboratively with dyad and other leaders in Research Administration and the Cancer Service Line in strategic plan development, implementation, and oversight
Develop and leverage professional relationships with sponsors, cooperative groups, and other grantors to grow the number and quality of available trials
Responsible for judicious selection of new studies with the clinical research team and physician partners to best maximize use of resources
Promotes available studies with the appropriate clinical teams, develops improved treatment planning workflows that highlight available clinical trials, continually monitors accrual rates amongst eligible candidates.
Improve financial performance of the CRU through improved sponsor budget negotiation, payment terms, billing and coding accuracy, and revenue tracking
Review contract budgets, study calendars, expense postings, and provide accurate and timely financial reports to key stakeholders
Review study operating procedures and staff roles and responsibilities to optimize efficiency and resource use as the team grows through use of using recognized best practices and innovative management reports
In conjunction with PMLGH Compliance Office and LGH Research institute, assess and interpret institutional and sponsor policies for compliance with laws, statutes, regulations, Medicare national and local coverage decisions. Leads or initiates internal risk audits and coordinates sponsor audits.
Provides oversite of the Clinical Trial Management System (CTMS). Ensure utilization is compliant with the University of Pennsylvania CTMS documentation requirements. Maximizes system capabilities to efficiently manage clinical trial internal documentation and milestone tracking including: study status, patient status, and study expenses/revenues.
Organizes and oversees oncology research oversite committee.
Participates in disease-site teams meetings, regulatory and compliance, Human Research Protection Program and ongoing protocol training/compliance meetings
Lead continuous improvement inititiatives within the CRU and represent the CRU in continuous improvement across the cancer research system
Commitment to equity in clinical trials access, screening, accrual, and completion
SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:
Recruit, mentor and develop CRU staff
Establish positive professional team culture
Develop and facilitate CRU relationships, trust, and education across the Lancaster community
Develops annual department budget, and manages monthly departmental revenues and expenses to achieve targets. Manages staffing resources consistent with approved budget goals. Ensures that staffing keeps pace with workload
Engages with LGH Foundation and key donors as needed to raise funds as required, service donor accounts, and inform stakeholders of progress made with their support
Other duties as assigned.
JOB REQUIREMENTS
MINIMUM REQUIRED QUALIFICATIONS:
Proven leader in clinical trials strategy, business development, and regulatory compliance
Minimum 5 years management experience in clinical trials
Experience and expertise with clinical trials management systems software
Thorough understanding of FDA, IRB, coverage analyses, as they apply to clinical trials conduct
Bachelor of Science degree or higher
PREFERRED QUALIFICATIONS:
Master’s level preparation, e.g. MHA
Prior experience of 5 years or more at director level in an NCI-certified academic Clinical Trials program
Oncology clinical trials experience
MD or DO degree
COGNITIVE REQUIREMENTS
Attention/Concentration: The following level of ability is essential for the jobholder to focus on certain aspects of current experience and reject others.
The position requires strong concentration skills. The individual must have the ability to voluntarily sustain concentration to a task over an extended period of time as a result of an effortful and usually deliberate heightened and focused state of attention.
New Learning and Memory: The following level of ability is essential for the jobholder to learn and retain material.
A large portion of this position requires reliance on verbal memory and new learning. Efficiency in processing of verbal information, either in written or spoken form, is a major requirement and prerequisite of the job. The individual must be able to attend to and process multiple bits of information simultaneously. The individual must be able to organize and categorize this information effectively so that later recall is feasible.
Problem Solving, Reasoning and Creative Thinking: The following level of ability that is essential for the jobholder to think (in order to solve a problem) by combining two or more elements from past experience or imaginative thought.
The position requires much autonomy of thought and problem solving. The individual must be able to apply principles of logical or scientific thinking to define problems. The individual must be able to think abstractly, which is manifested in the ability to form concepts, use categories, generalize from single instances, apply procedural rules and general principles, and be aware of subtle or intrinsic aspects of a problem. The development of hypothesis and potential solutions to problems involves careful interpretation, analysis and diagnosis. The individual must be able to collect data, establish facts, and draw valid conclusions. The individual must be able to think creatively with a degree of inventiveness, experimentation and intuition. They must be able to deal with a variety of concrete and abstract variables.
APTITUDES: The following are essential requirements of the position in relation to job-worker situations. These items describe how a worker must adapt, adjust, conform or act.
Leadership, control and planning: Ability to accept responsibility for leadership, direction, control, planning, negotiating, organizing, directing, supervising, formulating practices, or making final decisions.
Performing under stressful conditions: Ability to perform under stress when confronted with emergency, critical, unusual, or dangerous situations, or in situations in which working speed and sustained attention are critical aspects of the job. Is subject to danger or risk, or to tension as a regular, consistent part of the job.
Variety and change: Ability to perform a variety of duties, often changing from one task to another of a different nature without loss of efficiency or composure involving significant differences in technologies, techniques, procedures, environmental factors, physical demands, or work situations.
Communication: Ability to exchange information with others clearly and concisely; to present ideas, facts and technical information.
Interpersonal relations: Ability to maintain relationships that facilitate task accomplishment; to cooperate and resolve conflicts; to recognize needs and be sensitive of others.
EQUIPMENT USAGE REQUIREMENTS
Equipment/Tools: Computer, Phone, Copier, Printer, Fax, Office Supplies
Software: Microsoft Office Products, CTMS, EMR, Billing software
PHYSICAL REQUIREMENTS
Rarely 0-10%; Occasionally 11-35%; Frequently 36-70%; Continuously 71-100%
Body Position/Movement:
Sit: Frequently
Stand: Occasionally
Walk: Occasionally
Bend: Rarely
Push: Rarely
Pull: Rarely
Kneel/Squat: Rarely
Reach: Rarely
Twist: Rarely
Balance: Rarely
Climb: Rarely
Lifting: Degree of physical exertion is: Light, exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to move objects.
Sensory Abilities specifically required:
PHYSICAL ENVIRONMENT
WORKING CONDITIONS:
Exposure to hazardous conditions/ materials is negligible.
Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates, and should not be considered absolute. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. Incumbent must be able to perform all job functions safely.
PENN MEDICINE LANCASTER GENERAL HEALTH offers the following benefits to employees:
- 100% Tuition Assistance at The Pennsylvania College of Health Sciences
- Paid Time Off and Paid Holidays
- Shift, Weekend and On-Call Differentials
- Health, Dental and Vision Coverage
- Short-Term and Long-Term Disability
- Retirement Savings Account with Company Matching
- Child Care Subsidies
- Onsite Gym and Fitness Classes
Disclaimer
PENN MEDICINE LANCASTER GENERAL HEALTH is an Equal Opportunity Employer, committed to hiring a diverse workforce. All openings will be filled based on qualifications without regard to race, color, sex, sexual orientation, gender identity, national origin, marital status, veteran status, disability, age, religion or any other classification protected by law.
Search Firm Representatives please read carefully: PENN MEDICINE LANCASTER GENERAL HEALTH is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at PENN MEDICINE LANCASTER GENERAL HEALTH via-email, the Internet or directly to hiring managers at Penn Medicine Lancaster General Health in any form without a valid written search agreement in place for that position will be deemed the sole property of PENN MEDICINE LANCASTER GENERAL HEALTH, and no fee will be paid in the event the candidate is hired by PENN MEDICINE LANCASTER GENERAL HEALTH as a result of the referral or through other means.
