Director of Operations WHCRC (Center for Research on Reproduction & Women's Health)

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Director of Operations WHCRC (Center for Research on Reproduction & Women's Health)

 


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.

Posted Job Title
Director of Operations WHCRC (Center for Research on Reproduction & Women's Health)

Job Profile Title
Manager Research Project C

Job Description Summary
It is expected that the Director of Clinical Research Operations will implement and oversee all operational aspects of research within the Women's Health Clinical Research Center (WHCRC). The incumbent will provide regulatory and operational guidance and support to a diverse group of investigators ensuring compliance with investigator initiated as well as sponsored projects (federal and non-federal). This position will serve as a liaison between investigators, clinical research projects and clinical research support staff. The Director of Operations will work closely with the Grants Administration to ensure that Clinical Trials Agreements are reviewed and negotiated in a timely and efficient manner. She/he will also develop research budgets and negotiate terms with sponsors as well ensuring that spending projections are on course.

Job Description

The primary role of the Director of Operations is the organization, coordination and implementation of clinical trials, regulatory oversight of research, and support of faculty and clinical research staff within the Women's Health Clinical Research Center. The essential functions of the position include but are limited to:

Work with Investigators and Grant Administrators

 

 

  • Oversee negotiation Collaborative Research Agreements, Clinical Trial Agreements, Material Transfer Agreements and budget generation.
  • Establish professional and effective relations with University partners to ensure that negotiations stay on track and are completed in a timely manner.


Assist with Investigator Initiated research (Faculty, Fellow, Resident projects)

 

 

  • Determine regulatory review status (exempt, expedited, full board).
  • Assist with protocol/ICF design, CRF development, regulatory binder, data base set-up.
  • Train staff/coordinators on research conduct.
  • Monitor data or train staff to monitor data on a regular basis.


Provide training and guidance to investigators, trainees and support staff in OB/GYN on Good Clinical Practice and regulatory compliance. Work with investigators, practice managers and Vice Chair of Clinical Research to develop and maintain a clinical research infrastructure at University Pennsylvania Health System. Participate in the review and preparation of protocols for original, pharmaceutical and government clinical trials. Review protocols, informed consents, data collection forms, and advertisements for regulatory approval. Assist with grant writing and budget development; be responsible for tracking site reimbursement and allocating patient stipends and general revenue activity. Be responsible for oversight and review of SOPs and Quality Assurance plans. The Director of Clinical Research Operations should possess an in depth knowledge of Penn regulatory requirements, she/he will supervise other WHCRC support staff, Research Nurses and Clinical Research Coordinators.

Qualifications
Master's Degree with 5-7 years of experience in clinical research, data management, medical industry/CRO or equivalent combination of education and experience required. Position also requires an articulate individual with a strong background in women's health and patient education and management of clinical research regulations. Must possess excellent oral and written communication skills as well as the ability to work independently and also as part of a team. Strong planning and organizational capabilities along with problem solving skills desired.

Must be able to work flexible hours. Must be able to communicate comfortably and effectively with regulatory authorities/sponsor/investigators. Requires strong attention to detail in composing and proofing written materials. Superior computer skills with MS Word, Excel, PowerPoint, RedCap is required. Knowledge of GCP guidelines is a must.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$72,837.00 - $138,391.00

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.




To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/3701-Market-Street---8th-Floor/Director-of-Operations-WHCRC--Center-for-Research-on-Reproduction---Women-s-Health-_JR00036576





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