Under supervision of the Associate Director, Office of Research Compliance, the Clinical Research Associate II supports the research compliance program by conducting routine and for-cause monitoring and quality assurance activities (inclusive of Investigator-held IND and IDE studies) on behalf of CHOP’s Research Institute. Provides feedback to research teams and offers recommendations for practice modifications in accordance with OHRP, FDA, GCP, and Institutional guidelines.
Conducts routine and for-cause monitoring (including Investigator-held IND/IDE, Industry, and federally-funded research) and Quality Assurance (QA) activities. Clearly documents findings related to work performed.
Reviews research study compliance with applicable regulations, policies, and best practice guidelines. Confirms corrective and preventive action.
Consults with and advises CHOP IND/IDE sponsors in the development and implementation of risk-based monitoring plans for associated research protocols.
Organizes and oversees pre-trial monitoring for applicable IND/IDE studies; assists with research team training of protocol and regulatory requirements.
Following QA and monitoring visits, provides timely written and oral feedback on findings and actions needed to achieve compliance.
Advises on the development of recommended actions to achieve compliance.
Identifies areas for which new or refined policies or procedures are needed, and makes recommendations to the study team.
Identifies areas for which additional education and training are needed, and makes recommendations to the study team.
Provides off-site monitoring services, e.g., site initiation, routine, and close-out, to multi-site studies that require QA or monitoring support. Is available for travel <10% of time.
Conducts reviews of Institutional Review Board (IRB) documentation to confirm compliance with applicable regulations, policies and procedures, and accrediting agencies.
Performs reviews of Participant Research Card (PRC) transactions and documentation.
Conducts reviews of cost transfer data for Federally-funded research to ensure compliance with Federal and Institutional guidelines.
Assists with billing compliance reviews. Maintains templates and tools to support billing compliance reviews.
Participates in the development of comprehensive monitoring, quality review, and quality assurance program in the following areas:
Investigational Drug Services (IDS) Pharmacy
Assists with educational programs designed to promote adherence to research regulations and policies, including workshop development, collaboration with outside departments to address ongoing training initiatives, and individual training efforts on study teams. Within ORC, provides mentorship and guidance to CRA I.
Assists with special projects and activities in support of the research compliance program as assigned, including, but not limited to, the below:
Together with QA monitoring team, serves as Institutional PRS administrator, managing oversight of, and training for, Clinicaltrials.gov postings by research teams
Participates in audit readiness activities with research teams in advance of site inspection by federal (i.e. FDA, OHRP, NIH) and other agencies
In conjunction with the Associate Director, Research Compliance, develops policies, procedures, and institutional guidance documents to support research compliance at CHOP.
Maintains knowledge of developments in Federal regulations, current compliance trends, and hospital policies and procedures related clinical research; is able to independently assess impact of regulatory decisions on the research environment at CHOP.
Required Licenses, Certifications, Registrations
Professional Cert by nationally recognized research org (1 year)
Required Education and Experience
Required Education: Bachelor’s Degree
Minimum of 5-7 years relevant work experience in research compliance, and/or conducting monitoring or quality assurance audits in the research setting.
Equivalent combination of relevant education and/or experience acceptable.
Demonstrated knowledge of applicable federal, state and local regulations and guidance documents, pertaining to research compliance.
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).
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.
The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children’s Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research pro...gram is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 460-bed hospital recognition as a leading advocate for children and adolescents.