Are you passionate about ensuring the ethical and accurate conduct of clinical research? Do you have a keen eye for detail and the ability to effectively communicate with diverse teams? The University of Pennsylvania is seeking a highly skilled and dedicated Clinical Research Monitoring and Auditing Specialist to join our dynamic team. As a vital member of our research compliance department, you will play a crucial role in upholding the integrity and quality of our research studies. If you have a strong background in clinical research, exceptional organizational and analytical skills, and a commitment to upholding regulatory standards, we encourage you to apply for this exciting opportunity.
Conduct monitoring and auditing activities for clinical research studies to ensure compliance with ethical and regulatory standards.
Review and evaluate research study protocols, informed consent forms, and other relevant documents to ensure accuracy and adherence to regulations.
Identify potential areas of non-compliance and work with research teams to develop and implement corrective action plans.
Communicate findings and recommendations to research teams and higher management in a clear and concise manner.
Collaborate with internal and external stakeholders to develop and maintain standardized procedures and protocols for monitoring and auditing.
Stay up-to-date with relevant regulations, guidelines, and best practices in clinical research monitoring and auditing.
Participate in training and educational programs to enhance knowledge and skills related to clinical research compliance.
Develop and maintain effective relationships with research teams to promote a culture of compliance and ethical conduct.
Assist in the preparation and submission of reports to regulatory agencies and other governing bodies.
Maintain accurate and organized records of monitoring and auditing activities.
Identify and report any potential conflicts of interest or deviations from research protocols.
Work with research teams to develop and implement quality assurance plans for ongoing and future studies.
Participate in internal and external audits and inspections as needed.
Act as a resource for research teams regarding regulatory requirements and best practices for clinical research.
Contribute to the development and implementation of policies and procedures related to clinical research monitoring and auditing.
University of Pennsylvania is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.