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Clinical Research Program Manager I - Nephrology

Philadelphia, PA, US, 19104

Job Type: 

Location: LOC_COLKET-Colket Translational Research 

Req ID: 83696

Shift: Days

Employment Status: Regular - Full Time 

Job Summary

The Research Program Manager position in the Division of Nephrology will support Dr. Amaral’s research, Hand Transplant research and administration, and the CHOP It Up! Cooking Programs. The individual will be responsible for managing financial and regulatory aspects of Dr. Amaral’s research program and will play a major role in the coordination and implementation of study activities. The Program Manager will assist in the preparation of project deliverables including progress reports, final reports and papers for scientific publications. 

 

Dr. Amaral’s research focuses on complications of childhood kidney diseases, including chronic kidney disease (CKD), kidney transplantation, medication adherence, and developing educational gaming applications for solid organ transplant recipients. 

 

The candidate is expected to function independently in a clinical research setting and responsible for the complete coordination of a specific clinical research project(s), which includes multiple small to moderate, multi-center, mhealth & clinical trials. The ideal candidate will have clinical coordinator research experience and be comfortable with completing duties aligned with clinical research coordination.

 

Orients and trains internal and recruitment site staff handling research administration activities associated with conducting clinical trials. Monitors service levels, and identifies adequate coverage for trial workload across multiple studies varying in administrative complexity.

 

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.
  • 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 New Drug 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.
  • Engages in recruitment and bio-specimen collections/study visits as needed.
  • 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
  • Provide guidance and support for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
  • Provides supervision to research interns, students and research coordinators
Job Responsibilities (Continued)
  • 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.
  • Participates in conducting staff performance reviews and interviewing of new hires.
  • Assists with analysis of data and preparation of manuscripts and scientific presentations.
Required Licenses, Certifications, Registrations
Required Education and Experience

Required Education: Bachelors in related field

 

Required Experience: 5-7 years’ experience in clinical research

Preferred Education, Experience & Cert/Lic

Preferred Education: Masters in related field

 

Preferred Experience:

  • 3 years of experience in research administration or managing a research group, including budget administration, financial planning, and grants management.
  • Experience in an academic institution strongly preferred.
  • 1-2 years of supervisory experience in a clinical research environment.
Additional Technical Requirements
  • Excellent customer service and time management skills required. Must be able to work effectively with minimal direct oversight and manage multiple projects with varying deadlines for several individuals. Must be able to juggle multiple demands, work styles and needs.

     

  • Must have strong organizational skills, be able to work accurately, pay strict attention to detail, and be amenable to doing varied work that requires an intellectual and professional approach.

     

  • Successful performance in a high-intensity work environment.

     

  • Excellent problem identification and problem solving skills.  

     

  • Excellent written and interpersonal skills.

     

  • Ability to handle confidential matters and materials.
     
  • Evidence of leadership ability.

     

  • Ability to work with sensitivity to cultural diversity and to assist staff in understanding this diversity.

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.

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 

 

 

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