Clinical Research Associate I - CCCR PSO

at  Childrens Hospital of Philadelphia

SHIFT:

Day (United States of America)
The Clinical Research Associate (CRA) in the Protocol Support Office [PSO] performs comprehensive monitoring of clinical research studies within the Division of Oncology and the Center for Childhood Cancer Research (CCCR) under the guidance of the program manager. This role will also help to support monitoring responsibilities for the Children’s Oncology Group (COG) and provide audit prep support for the division.
The CRA promotes good clinical practices by possessing an in-depth knowledge on the conduct of clinical trials and human subject protection. The CRA will serve as a resource for clinical research teams to help ensure protocol and regulatory requirements have been met. This role 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.

Job Functions

• Scheduled monitoring of clinical research studies
• Review of regulatory documents, including protocols, amendments, correspondence, and serious adverse events/adverse events reports
• Audit or monitor study conduct, including the consent process, eligibility criteria, and case report forms
• Conduct review of pharmacy records, when applicable
• Provide training/guidance for study teams (principal investigators, CRCs, and clinical research nurses) as needed

Essential Functions

• Facilitate audit preparation when external audits are expected/announced
• Maintain knowledge of developments in Federal regulations, current compliance trends, and hospital policies and procedures related clinical research
• Collaborate internally to review, improve and promote processes and procedures
• Ensure activity compliance and quality control with protocol and regulatory requirements
• Coordinate compliance, documentation and submissions for regulatory agencies
• Manage related data collection, analysis, management and databases / system use.
• Assist with activities including assessments, enrollment and collection.
• Assist with researching to develop methodologies, instrumentation and procedures

EDUCATION QUALIFICATIONS

• Bachelor’s Degree Required
• Master’s Degree in a related field Preferred

EXPERIENCE QUALIFICATIONS

• At least one (1) year quantitative analysis, data management or regulatory research experience Required
• 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 (EndNote, 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 skills
  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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

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 to develop 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

Essential Functions

• Facilitate audit preparation when external audits are expected/announced
• Maintain knowledge of developments in Federal regulations, current compliance trends, and hospital policies and procedures related clinical research
• Collaborate internally to review, improve and promote processes and procedures
• Ensure activity compliance and quality control with protocol and regulatory requirements
• Coordinate compliance, documentation and submissions for regulatory agencies
• Manage related data collection, analysis, management and databases / system use.
• Assist with activities including assessments, enrollment and collection.
• Assist with researching to develop methodologies, instrumentation and procedure