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Job Title: Clin Research Project Mgr II-Division of General, Thoracic and Fetal Surgery
Job Number: 14082
Organization: Children's Hospital of Philadelphia
Posted: 10/11/2017
Type: Full-Time
Classification: Health Care - General
Industry: Non Profit / NGO
Number of Openings: 1
Location: Philadelphia,  PA    USA
Compensation: Unspecified
Position Description: Job Summary

The Division of General, Thoracic and Fetal Surgery is seeking a clinical research manager with experience coordinating research studies, clinical trials and IRB processes and procedures. The research project manager plays a key leadership role in various clinical outcomes projects of the Center for Fetal Diagnosis and Treatment and General Surgery working directly with Principle Investigators.

The Center for Fetal Diagnosis and Treatment at The Children's Hospital of Philadelphia is an internationally recognized leader in fetal diagnosis, fetal surgery and fetal care. Since 1995, we have cared for more than 20,000 expectant parents from around the world and performed more than 1,500 fetal surgeries, more than any other program in the world.

Our Center is led by N. Scott Adzick, M.D., M.M.M., a pioneer in the field of fetal medicine who has devoted more than 30 years to groundbreaking work in the field of fetology. We are one of only a few programs worldwide to offer comprehensive prenatal diagnosis, fetal therapy and the option of delivering at a leading pediatric hospital. Our Garbose Family Special Delivery Unit (SDU), the world’s first birth facility exclusively for healthy mothers carrying babies with known birth defects within a children’s hospital, has delivered more than 3,000 babies since it opened in 2008. Babies delivered in the SDU are cared for in our world leading surgical neonatal and infant intensive care unit (NI/ICU) by dedicated specialists.

Our experienced, multidisciplinary team includes maternal-fetal medicine specialists, reproductive geneticists, obstetricians, neonatologists, fetal-neonatal pediatric surgeons, anesthesiologists, fetal imaging specialists, fetal cardiologists, genetic counselors, advanced practice nurses, social workers and psychologists. This team sees rare, complex anomalies every day and cares for these patients from prenatal diagnosis through

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. Submit Investigational Device Exemption (IDE), and Investigational New Drug (IND) applications to the FDA as required.

Audits operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.

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 finance

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.

Will 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.

Qualifications: Required Licenses, Certifications, Registrations

None

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 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 Address: 3401 Civic Center Blvd. Philadelphia, PA 19104 Phone: 866-820-9288 Email: TalentAcquisition@email.chop.edu

Organization Description: Since its start in 1855 as the nation's first hospital devoted exclusively to caring for children, Children's Hospital of Philadelphia has been the birthplace for many dramatic firsts in pediatric medicine. The Hospital has fostered medical discoveries and innovations that have improved pediatric healthcare and saved countless children’s lives.

Today, Children's Hospital of Philadelphia is one of the leading pediatric hospitals and research facilities in the world. Our 150 years of innovation and service to our patients, their families and our community reflect an ongoing commitment to exceptional patient care, training new generations of pediatric healthcare providers and pioneering significant research initiatives.

Closing Date: 1/11/2018
Desired Starting Date:
Contact Name: Ashley Quinn,  Clin Research Project Mgr II-Division of General, Thoracic and Fetal Surgery
Contact Location:

    
United States
Contact Location:
 
      
  United States
Contact Phone:  
Contact Fax:
Contact Email: quinna5@email.chop.edu
Web Address:
How to Apply: All interested candidates will want to visit the CHOP website and apply at:

https://careers.chop.edu/job/Philadelphia-Clin-Research-Project-Mgr-II-Division-of-General%2C-Thoracic-and-Fetal-Surgery-PA-19104/432719600/?utm_source=emory

Additional Information:

Web Site Delete Date: 11/10/2017