Job location: HUP

Employment Type: Full-time
Posted data: 2021-10-26
Req: JR00033883
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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn’s vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title

Sr. Project Manager (Dept. of Renal - Electrolyte & Hypertension)

Job Profile Title

Manager Research Project B

Job Description Summary

The Project Manager will lead the operations for the Data Coordinating Center (DCC) for two related multicenter studies (one observational study and one clinical trial) to elucidate mechanisms underlying diabetic kidney disease.

Job Description

Responsibilities include leading project development; preparing, revising, and submitting protocols; managing protocol execution at collaborating sites, preparing and maintaining study documents and supplies; collecting and processing specimens shipped to Penn; managing periodic shipping of biologic samples to study Sponsors and Investigators; reporting and tracking adverse events; maintaining the study databases and overseeing data entry; tracking data quality and completeness; monitoring completion of study procedures by participants at all sites; drafting and sending correspondence; coordinating accrual of participants for all sites in the study; and performing additional study related duties as required. The project manager will be responsible for ensuring regulatory compliance by all sites relying on Penn's IRB as the Central IRB and overseeing regulatory compliance by sites operating under their own institution's IRB. Experience with REDCap will be very helpful.

Duties:

* Manage the Trident Consortium infrastructure by serving as the primary central point of contact for 19 active sites and troubleshoot any study related issues. Manage the closing of three formerly active sites. Organize Executive Committee and Steering Committee meetings; provide study updates in the form of monthly calls with coordinators, monthly emails to PIs and quarterly Bulletins to the consortium. Mange bi-weekly TRIDENT Core team meetings. Manage communication for P&P and Ancillary Committees. Train and oversee all coordinators implementing protocols at outside sites. Regularly interact with sites, sponsors, Principal Investigators, and other regulatory agencies.

Manage time, prioritize activities, and exercise mature judgment, and that a high level of independence, attention to detail, strong written and verbal communication skills, and leadership ability are expected. The individual should have demonstrated ability to work as part of team as well as independently.

* Oversee the implementation of TRIDENT 2.0, to be merges with the Trident Consortium as a separate study under the same umbrella. Set-up the active recruiting sites, preparing training documents, coordinate study drug dispensing and storage with IDS, assist the contract and budget office, communicate updates with study PI and funding sponsors, manage IRB submissions and safety reporting to DSMB and FDA (if necessary).

* Correspond with IRB and other regulatory agencies for both Trident and TRIDENT 2.0, including the preparation and submission of protocols, protocol amendments and SAE reports locally. Manage regulatory compliance of all sites relying on Penn's IRB as the Central IRB and oversee regulatory compliance of sites operating under their own institution's IRB.

* Manage timelines for both studies, recruitment strategies, and evaluation of study needs and resources. Oversee screening, recruitment and consenting of patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants at local recruiting sites. Responsible for sample collection; processing for specimens shipped to Penn; managing supplies for sites and Core Team.

* Maintain patient databases and study trackers for Trident and TRIDENT 2.0; oversee continued database maintenance and lead any enhancement activities; manage the Data Review Team and oversee data entry and management of study subject databases by periodically completing audits.

* Monitor study progress for Trident and TRIDENT 2.0 and report regularly on study progress to PI and funding sponsors including written reports, email communications and reports to the DSMB. Develop and maintain MOPs, study case report forms, source documents and training SOPs and ensure implementation at all the recruiting sites.

* Participate in drafting trial protocol, manual of operations. Develop trial data forms and data management system. Seek additional resources to continue the vitality of the Trident Consortium by proactively updating and implementing both short-term and long-term plans.

* Supervise and delegate tasks for the Trident 2.0 CRC C. it may be necessary to delegate several of the regulatory, data, and administrative tasks to the CRC C with careful supervision and oversight.

* Creating REDCap data management systems, case report forms, and monitoring multi-site data is required.

* Perform additional duties as assigned

***Position is contingent upon funding***

Qualifications
Master's Degree with 3-5 years of related experience or equivalent combination of education and experience is required

Working Conditions
Office, library, computer room

Physical Effort
Typically sitting at a desk or table; Occasional lifting 25 lb. or less; Typically standing or walking

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$59,703.00 - $113,435.00

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