Reference #: 1008071 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's Commitment to Diversity, Equity, and Inclusion

CHOP 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 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 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 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 su porting 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.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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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.