Skip to Main Content

CLINICAL TRIALS RESEARCH PROJECT MANAGER

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.

If you would like to bookmark this position for later review, click on the Bookmark link. If you would like to print a copy of this position for your records, click on the Print Preview link.

Posting Details

Posting Details

Reference Number 40-27469
Posted Job Title CLINICAL TRIALS RESEARCH PROJECT MANAGER
School Name Perelman School of Medicine
Org CC-Cancer Center
Posted to the Web 12/04/2017
Posted Job/Salary Grade 028
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8am-5pm
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

The Project Manager for the Breast Cancer Clinical Trials Unit will oversee, direct and participate in all operational aspects of breast cancer clinical trials This individual will supervise the Breast Clinical Trials Program research coordinators, data managers and research assistants in their functions, as well as directing the process of implementing new trials, screening new patients for trial participation, performing data quality assurance, interacting with sponsors, providers, and other team members and assisting with other duties as outlined by the Program Manager, Physician Directors or Program Principal Investigators.

Project Manager duties may include, but will not be limited to (1) supervising and assisting in the conduct of clinical research coordinator and data management duties for a portfolio of clinical research trials, assigning trials and tasks to this group and managing overall workflow, (2) managing the overall process of data collection and submission by CRCs, (3) training and maintenance of ongoing education of clinical research staff, (4) develop new recruitment strategies and functioning as a liaison to outside physicians and patients seeking entry to UPenn breast cancer trials, and (5) supervising and assuring quality of data collection, working closely with staff, sponsors and regulatory bodies. This individual will work closely with the Biospecimen Lab Coordinator to implement specimen management across all clinical trials; manage and report on study results; work closely with study staff to manage participant visit schedules; manage Investigator’s protocols with regulatory personnel including renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of associated regulatory reports (SAE, deviation, IND safety reports) to ensure timely review/approval by institutional review board; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain U Penn approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; help the coordinators prepare for and participate in any internal and external audits or reviews of study protocols. PM will have oversight of study coordinator team responsibilities and work closely with the Director and Lead nurse to ensure studies are opened and staffed appropriately. The PM with be responsible for the day to day management of research and associated staff activities. The PM will lead team meetings and participate and create training activities for new staff and assist in ongoing trainings for all staff. PM will have the ability to collect, review and report study data, complete case report forms and source document tools as well as serve as a resource/oversee for staff in the successful and timely completion of these activities. The incumbent will establish and maintain positive, professional working relationships with monitors, auditors, sponsors, investigators and other relevant personnel associated with the study from start until its completion.

PM responsibilities include distributing and managing coordinator assignments as trials transition in and out of the program, managing coordinators who will be recruiting patients, coordinating study visits involving human subjects, that may require careful safety checks are essential prior to performing study procedures; supervise coordinators performing data entry and perform frequent quality control checks to ensure data integrity; and assist research staff in resolving data queries. The PM will assume some coordinator tasks on occasion as needed by the coordinator team. The PM will work with all members of the research team in a highly collaborative and supportive role to ensure complex studies with human subjects are carried out in an ethical, legal, timely and highly precise manner. The PM will be a liaison with other U Penn departments (e.g. Radiology, Clinical Labs, IDS, CRU staff, Regulatory) as it pertains to study needs. The PM will also assist with protocol and resource management and clinical study organization. The PM will be responsible for completing administrative tasks as needed and all duties associated with this position. The PM will participate in strategic planning activities. The PM will work well in a fast paced, task oriented environment and exhibit outstanding character traits focused on efficiency, collegiality, support and respect for leadership, team mates, patients, families and all others involved in any aspect of the job.

Qualifications

A Bachelors degree and 5-7 years or Master degree with 3-5 years of related experience, or an equivalent combination of education and experience, are required.

Effective problem solving abilities, effective communication and writing skills, strong organizational and time management skills required. Supervisory experience helpful. Progressively responsible clinical research experience strongly preferred. Knowledge IRB and human research protection regulations (AE reporting, IND safety reports, monitoring and auditing)
Must be able to work well in a fast paced, task oriented environment and exhibit outstanding character traits focused on efficiency, collegiality, support and respect for leadership, team mates, patients, families and all others involved in any aspect of the job. Have the ability to establish and maintain positive, professional working relationships with monitors, auditors, sponsors, investigators and other relevant personnel associated with the study from start until its completion

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
Quick Link http://jobs.hr.upenn.edu/postings/33197

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

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter