Einhorn Insitute - Clinical Research Associate II

SHIFT:

Seeking Breakthrough MakersChildren’s [Employer] of [Employer] (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 OverviewThis role oversees clinical research activities with a focus on technical and analytical work in support of the data analysis and data management needs of the team. Strategic oversight of gathering, analyzing, and making recommendations or decisions based on data is key as it relates to manuscript writing and reporting to different federal agencies. May have minimal patient-facing coordination responsibilities. 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 HIPAA 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 software (EPIC)
• Intermediate proficiency with office software (Microsoft Office) including word processing, spreadsheet, and presentation software (Word, Excel, PowerPoint)
• Intermediate proficiency with academic / reference management applications (EndNote, Mendeley)
• Intermediate proficiency with electronic data management systems (REDcap)
• Familiarity with survey software (Qualtrics) online crowdsourcing marketplaces (MTurk) and statistical software (SPSS/SAS) R/Python

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.EEO / VEVRAA Federal Contractor | Tobacco Statement

SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.

Originally posted on [Employer]