Director, Clinical Research Operations (Department of Dermatology)

Description

Job Responsibilities

• Serve as the day-to-day operations lead for the principal investigators (PIs) and clinical research staff within the Dermatology Clinical Studies Unit (CSU).
• Directly manage and supervise the CSU staff (program managers, clinical research nurses, clinical data specialists, clinical research coordinators, and clinical research assistants).

This includes responsibility for performance management and overseeing hiring and staff training / onboarding.

Work collaboratively with PIs and the Director of Clinical and Translational Research 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.

Assess the need for additional staff for the unit and develop strategic business plans for hiring additional staff as needed.

Interview candidates, check references, recruit new and replacement staff, and ensure training and onboarding.

Directs the flow of new clinical research studies through the study life cycle, by identifying operational obstacles and propose improvements to the process.

Implements general and trial-specific strategies that assure effective enrollment and optimal data quality.

Work in conjunction with the Dermatology Business Office and the Director of Clinical and Translational Research to ensure the allocation of fixed (personnel / space / equipment) and financial resources;

collaborate with the preparation and negotiation of budgets as needed; and ensure that all clinical trials are conducted in accordance with the study protocol.

Collaborate with the Director of Clinical and Translational Research to develop operational process improvements and tools to ensure adherence to standard operating procedures (SOPs), GCP, and requirements of all applicable regulatory bodies, increase workflow efficiency, and quality of research.

Direct the development and implementation of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control processes.

Frequently assess protocol compliance and data quality across the unit.

Adoption and utilization of the Clinical Trial Management System (Penn CTMS) for all studies conducted within the CSU.

Develop, monitor, and retain program metrics (performance, portfolio, and enrollment); Remain actively engaged in organizational goals especially those directly related to all trials.

• Lead research team meetings and oversee protocol training / compliance meetings.
• Serve as the primary operations liaison for internal collaborative departments.
• Perform other duties and responsibilities as assigned.

Qualifications

Bachelor’s degree and 7-10 years of related experience required; Master’s Degree and 5-7 years of related experience 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 principal responsibilities related to clinical research and or research education preferred.

Prior leadership experience preferred.

• Able to confidently interact with all levels of management including senior management, physician leaders and others.
• Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans.
• Must be detail oriented and organized.
• Excellent verbal / written communication skills required.
• Must be a demonstrated initiative-taker and team player with strong interpersonal skills.
• Prior experience in developing policy or procedural documentation, and or guidance documents is desired.
• Excellent technical writing, review, and analytical and problem-solving abilities; Excellent interpersonal and multi-tasking skills.
• Ability to work collaboratively on all levels and to gain support from others. The 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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$140,000.00 - $170,000.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

University Benefits

Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare.

You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn.

Your dependent children are also eligible for tuition assistance at other institutions.

Retirement : Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis.

Choose from a wide variety of investment options through TIAA and Vanguard.

Time Away from Work : Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family whatever your personal needs may be.

Long-Term Care Insurance : In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.

If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements.

Eligible family members must always provide proof of good health and are subject to underwriting.

Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life.

That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

Professional and Personal Development : Penn provides an array of resources to help you advance yourself personally and professionally.

University Resources : As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities.

Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples.

As a member of the Penn community, you’re right in the middle of the excitement and you and your family can enjoy many of these activities for free.

Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff.

Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff.

You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

Flexible Work Hours : Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments.

These approaches involve use of non-traditional work hours, locations, and / or job structures.

Penn Home Ownership Services : Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

Adoption Assistance : Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.