Clinical Research Associate II-Clinical Immunology Lab

Reference #: 1011030

SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren'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's Commitment to Diversity, Equity, and InclusionCHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.A Brief Overview

This role supports the work of Lisa Eidenschink Brodersen,PhD, HCLD, ABB - this position performs clinical research activities with a focus on technical and analytical work in support of the data analysis and data management needs of the team.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 responsibilitiesThe preferred applicant should have prior flow cytometry experience specifically related to instrumentation and QC/QA expertise.What you will do

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 and quality control with protocol and regulatory requirements.

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 and developing methodologies, instrumentation, and procedures.

Participate in department presentations and publications.

Supporting Investigators in grant preparation (draft methods, contribute to strategy component)

Presentations, Publications, and related development

Assists in reporting (progress) and methods for applications

Additional duties may include:

Patient coordination

Education Qualifications

Bachelor's Degree Required

Master's Degree in a related field Preferred

Experience Qualifications

At least one (1) year of quantitative analysis, data management, or regulatory research experience is Required.

Prior flow cytometry experience Specifically related to instrumentation and QC/QA expertise.

At least three (3) years quantitative analysis, data management or regulatory research experience Preferred

At least three (3) years of relevant and complex clinical research experience Preferred

Skills and Abilities

Advanced knowledge of medical terminology

Intermediate knowledge of clinical research methods

Intermediate knowledge of international regulations regarding research, Good Clinical Practices (ICH / GCP)

Intermediate knowledge of HIPPA regulations and policies and procedures governing human subjects research

Basic knowledge of Institutional Review Board (IRB) processes and policies

Basic 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)

Basic proficiency with academic / reference management applications (En Note, Mendeley)

Basic proficiency with electronic data management systems (REDcap)

Familiarity with survey software (Qualtrics), online crowdsourcing marketplaces (MTurk) and statistical software (SPSS/SAS) R/Python

Excellent verbal and written communications skills

Excellent critical thinking / problem-solving skillsTo 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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.EEO / VEVRAA Federal Contractor | Tobacco StatementChildren'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.