Dental Hygienist, Clinical Research Assistant
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Established in 1878, Penn Dental Medicine is among the oldest university-affiliated dental schools in the nation. Penn Dental Medicine (PDM) is on a mission to provide the highest quality clinical and research environment for students while shaping the future of care. Join Penn Dental Medicine to live that mission every day by supporting the research and clinical needs of our patients, students, faculty, staff, and community. With PDM, not only can you maximize your career potential at an Ivy League Institution, but you can make a real difference in the lives of our patients and students. http://www.dental.upenn.edu/
The Dental Hygienist, Clinical Research Assistant is responsible for delivering trial treatment/intervention to research participants at the University of Pennsylvania, School of Dental Medicine. He/she will conduct dental examinations, including dental and periodontal assessments; review subject questionnaires and medical records; administer study interventions in accordance with the study protocol; and collect and record data during implementation of study procedures. Ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPPA, and other federal/institutional requirements, and meet required obligations to patient/subject, Principal Investigator, research team and the sponsor. Directly interface with patients/subjects, the Principal Investigator, and study team in support of the clinical trials.
Conduct dental exams, incl. dental and periodontal assessments; take x-rays; perform/conduct study intervention per protocol; record treatment and procedures; provide oral hygiene education; meet with subject for each treatment/intervention visit and maintain accessibility to discuss any questions/concerns; ensure subject’s referring physician receives notification if requested by the subject; set-up and break-down the clinic area before/after study visits, including instrument sterilization.
Demonstrate knowledge of and follow all policies and procedures of the host institution where the study is being conducted, applicable state and federal regulatory requirements, ICH GCP, Institutional Review Board (IRB) policies, HIPPA, and other requirements as appropriate; demonstrate a thorough knowledge of the research study, study rationale, study subject, and clinical procedures associated with each study to which he/she is assigned.
Participate in study administrative activities, including active engagement during study meetings and assisting with the maintenance of complete and accurate subject charts, case report forms, study logs, hospital records from patient screening through final follow-up, and other essential documents; attend and participate in study training sessions and annual calibrations.
In consultation with the study investigators, identify and assess potential adverse events; ensure that adverse events are properly documented and reported; screen laboratory results when received and follow protocol procedure regarding abnormal results; ensure all laboratory results are given to appropriate physicians for review of clinical significance, and file results in the subject study binder.
Assist in the development and implementation of recruitment strategies; review all the elements of the screening process with PI (inclusion/exclusion criteria, the informed consent process, and documentation of consent); assist in the recruitment and screening of potential patients/subjects for eligibility, which may include gathering information from the medical record, fielding physician referrals, posting advertisements, and directly scheduling visits to evaluate the patient/subject.
Assist with the informed consent process and ensure that the patient/subject fully understands what is required of them; discuss protocols with patients and verify informed consent documentation; ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled. Record study data as appropriate, record/update/edit/maintain confidential information onto paperwork or web-based forms in a neat, accurate, and timely manner.
Assist clinical research coordinators in conduct of study visits which includes: participating in informed consent process; recruiting subjects through review of medical records, physician referrals, advertising, and direct patient contact; scheduling visits; assisting in screening/ enrollment of subjects; organizing/running visits; performing study assessments/procedures; and assisting with collection, preparation, shipment, and/or storage of biological materials using universal precautions.
Assist the Lead CRC with QA/QC processes; implement QA/QM plans; review study records, including charts, case report forms, informed consent forms, and other documents, for accuracy/completeness; identify and seek correction of errors/omissions within records; draft reports of QA activities and provide to appropriate parties; assist in the development and implementation of corrective action plans as necessary.
Interact with patients/subjects and families in a courteous and professional manner; show consistency and regular follow through with his/her patients/subjects; respond to requests in a timely manner, give complete and accurate information, and encourage required dialogue and follow- through; utilize available resources and established procedures to identify problems ideally before they happen, suggest solutions, and implement corrective action for quick resolution.
Degree in Dental Hygiene and current PA State license is required, plus at least 1 year of experience that is directly related to the duties and responsibilities specified. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective verbal and written communication skills and strong analytical, organizational and interpersonal skills. Ability to work within a team environment as well as independently. Commitment to continuous learning as required by department administration. Ability to make decisions independently. Ability to manage time, multi task and prioritize work. Ability to identify, analyze and solve problems; ability to work well under pressure.
Knowledge of basic medical terminology, experience working in an Academic Medical Center, and research experience are preferred. Business and dental office setting. Comprehension of dental/dental hygiene scope of practice and impact on clinical operations.
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.