CHOP EMPLOYEE? SEARCH FOR JOBS HERE.

Clinical Research Project Manager II

Philadelphia, PA, US, 19104

Job Type: 

Req ID: 22005

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

Functions independently in a clinical research setting and responsible for the complete coordination of a specific clinical research project(s) which may include multiple moderate to large scale clinical epidemiology studies.  Orients and trains staff handling research administration activities associated with conducting clinical studies of varying complexities. Monitors service and staffing levels and oversees the operational aspects of the research team. 

 

The Project Manager will play a pivotal role in the development, execution, and dissemination of research studies evaluating the accuracy of adverse event reporting on cooperative group clinical trials, anthracycline associated cardiac toxicity, and disparities in pediatric cancer outcomes. This work will include managing regulatory approvals, project timelines, manuscript submissions for the PI, and study staff. The Project Manager will also be involved in interpretation of statistical analyses and manuscript preparation as well as grant preparation and writing. This work will utilize a wide range of data sets including large, administrative data sets such as the Pediatric Health Information Systems data, cooperative clinical trial group data such as the Children’s Oncology Group, large-scale electronic medical record data, patient reported outcome data, and observational cohort data. The Aplenc research group also has access to next generation sequencing data that will be analyzed by other investigative teams but integrated into data sets actively used by the Aplenc laboratory.

Job Responsibilities

•    Supervises the implementation of and adherence to study protocols. Educates research and clinical staff on established policies, processes, and procedures.
•    Determines effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. 
•    Develops consent forms for approval by Human Subjects Panel.
•    Oversees and/or coordinates new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.  
•    Completes annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. 
•    Monitors Institutional Review Board submissions, and responds to requests and questions.
•    Provides leadership and expertise in identifying and completing research grants.
•    Oversees financial resources, as needed, creates internal and external budgets for research protocols, assures financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
•    Provides oversight for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team. 
•    May directly supervise Project Manager I’s and Clinical Research Coordinators assigned to the project.

 

Management Group
•    Leads or chairs committees or task forces to address and resolve significant issues.
•    Engages in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
•    Analyzes trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
•    Assists with analysis of data and preparation of manuscripts and scientific presentations.

Required Education and Experience

•    Required Education: BA/BS in related field.

•    Required Experience: 5+ years of relevant clinical research experience; prior experience leading clinical research projects.
 

Preferred Education, Experience & Cert/Lic

•    Preferred Education: MA/MS/MPH in related field

•    Preferred Experience: 3+ years leading relevant clinical research projects
 

Additional Technical Requirements

•    Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies. 
•    Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.
 

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.  Please contact our hiring official with any referrals or questions.

CHOP Careers Contact 

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146 

Phone: 866-820-9288 

Email:TalentAcquisition@email.chop.edu

 

 

CHOP EMPLOYEE? SEARCH FOR JOBS HERE.


Nearest Major Market: Philadelphia

Job Segment: Clinic, Epidemiology, Medical, Oncology, Healthcare, Research