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CLINICAL TRIALS PROJECT MANAGER

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Posting Details

Posting Details

Reference Number 40-27237
Posted Job Title CLINICAL TRIALS PROJECT MANAGER
School Name Perelman School of Medicine
Org CC-Cancer Center
Posted to the Web 11/03/2017
Posted Job/Salary Grade 027
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8am to 5 pm
Months 12
Position Length Contingent Upon Funding
Position End Date
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.

School/Center Overview

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/

Duties

This position will report to the Principal Investigator at the Clinical Research Unit at Penn Presbyterian Medical Center and will also work closely with the Lead Nurse for the group, if one has been designated. The successful candidate will work closely with disease group investigators to oversee all aspects of the research being performed within their group. This includes assisting with study selection, prioritization of the team’s work, working closely with the Regulatory Manager to manage, review and initiate trials. Project Managers are expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team’s work during absences or when a specific team member’s workload exceeds capacity (including, but not limited to, managing patient visits, transporting specimens, data entry, query resolution and working with study monitors).
Specific responsibilities include (but are not limited to):
* Working with disease site physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources, anticipate any need for a disease group to hire additional staff based on data analysis and develop a business proposal to reflect any needs
* Submitting complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts
* Performing group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
* Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed
* Work closely with the Regulatory Manager of the CRU to manage review and startup of trials
* Working with team members to ensure accurate and timely data entry into Velos (our electronic Clinical Trials Management System), including study status, screening logs, serious adverse events and subject enrollment status
* Closely monitoring and reporting to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
* Conducting weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and other issues needing to be addressed
* Monitoring staff workload and work with other disease teams and Administrative Director to share or borrow staff when needed and appropriate. This will include management of staff paid time off.
* Attending disease group meetings, site initiation visits, and (as needed) monitoring visits.
The candidate will work closely with the CRU Administrative Director to develop and implement SOP’s, report team study metrics and communicate issues that may affect overall research with CRU Trials. The Research Manager may also have primary study coordinator responsibility for at least 1 study.

Qualifications

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

Bachelor’s degree and 3-5 years of related experience, or an equivalent combination of education and experience, are required.

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.
Quick Link http://jobs.hr.upenn.edu/postings/32557

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * 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
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * 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
  4. * Do you have experience with IRB and human research protection regulations?
    • Yes
    • No
  5. * Do you have excellent organizational and time management skills?
    • Yes
    • No

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter