Clinical Research Program Manager I - Nephrology

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.

• 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

• 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 Education: Bachelors in related field

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

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.

• 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.