Clinical Research Associate II - Clinical Futures

SHIFT:

Day (United States of America)

Seeking Breakthrough Makers

Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career.



CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.


A Brief Overview
This position is offered through Clinical Futures at the Children’s Hospital of Philadelphia. Under minimal supervision, the clinical research associate will coordinate all clinical research activities within the scope of clinical research protocols.

This position will support Dr. Emily Gregory’s research projects. Dr. Gregory is a primary care physician and a maternal-child health services researcher. Current projects examine the impact of Medicaid policy on birth outcomes and insurance enrollment during early adulthood, primary care support for breastfeeding and other maternal health needs, and emerging use of GLP-1 medications in pediatric settings. The position offers the opportunity to be part of an active, interdisciplinary research team; contribute to research projects; develop research skills; and participate in or lead dissemination of research findings (e.g. presentations, publications).

The ideal candidate will have:
· Experience supporting grant writing and submissions, manuscript writing and submissions, seeking approval from institutional review boards, and working with student research assistants.
· Experience using data management and analysis programs such as R, python, or Stata, to support or conduct research using electronic health records, administrative claims data, or other large datasets.
· Experience working with diverse low-income urban families through prior work, volunteer, or other experience and a strong interest in and commitment to maternal child health research and policy that aims to improve outcomes for children and families.

A candidate with doctoral training is preferred; however, we will consider applicants with a master’s or bachelor’s degree in a health-related field and relevant experience.

What you will do

• Activity Management
• Oversee staff work and the coordination of projects.
• Manage participant flow, quality controls, eligibility assessments and reviews.
• Plan and direct activities, methods, and treatments.
• Collaborate internally to review, improve and promote processes and procedures.
• Manage related data collection, analysis, management and databases / system use.
• Ensure activity compliance with protocol and regulatory requirements.
• Activity Coordination and Support
• Coordinate compliance, documentation and submissions for regulatory agencies.
• Direct and maintain related documentation, records, and events.
• Assist with activities including assessments, enrollment and collection.
• Assist with researching to develop methodologies, instrumentation and procedures.
• Participate in department presentations and publications.

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in a related field such as Clinical, Research or Regulatory Preferred

Experience Qualifications

• At least three (3) years of relevant and complex clinical research experience Required
• At least five (5) years of relevant and complex clinical research experience Preferred
• At least five (5) years quantitative analysis, data management or regulatory research experience Preferred

Skills and Abilities

• Advanced knowledge of medical terminology
• Advanced knowledge of clinical research methods
• Advanced knowledge of international regulations regarding research Good Clinical Practices (ICH / GCP)
• Advanced knowledge of international / government regulations regarding research
• Advanced knowledge of HIPPA regulations and policies and procedures governing human subjects research
• Intermediate knowledge of Institutional Review Board (IRB) processes and policies
• Intermediate knowledge of research design, data analysis and writing
• Intermediate proficiency with electronic medical record sof