Posting Note: The manager is looking for the following: • Experience in clinical and epidemiological research. • Experience in IRB preparation, compliance and regulatory aspects of clinical research. • Experience in clinical research project management. • Experience in experimental and other methods such as developing surveys and other instruments used to conduct prospective and retrospective studies for both experimental and non-experimental projects. • Experience in using Red Cap or other similar cloud-based data collection software; • Experience in designing, coordinating, and conducting research activities and statistical studies using statistical software (e.g.,SPSS, SAS, R). • Experience in conducting literature reviews in medicine and public health • Experience in creating and maintaining databases utilizing various computer programming languages or user-oriented software, such as SPSS used to generate information for management decision making and evaluation of programs. • Experience using Microsoft Office (Excel, Access, Word, PowerPoint, Visio). • Coursework in science, statistics, public health, medicine or related field. • Experience in project management and time management. • Experience in working in a diversified team environment and maintaining effective interpersonal relationships
This position coordinates a variety of research projects to include working independently in the acquisition of specimens, extraction of data from patient charts and analysis of data per protocol as well as administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state and regulatory agency requirements, and specific institutional requirements.
- Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
- Excellence in clinical care, service and communication
- Collaborative within our institution and with others who share our mission and goals
- Leadership that set the standard for pediatric health care today and innovations of the future
- Accountability to our patients, community and each other for providing the best in the most cost-effective way.
Provides nursing care to research study patients, including:
- Performing and/or scheduling medical tests including, but not limited to, blood draws, vital sign readings, imaging studies, cardiac and/or pulmonary function tests.
- Administering study medications and performs patient assessment during clinic visits to determine presence of side effects to medication; notifies principle investigator of findings/issues.
- Providing patient education and medical information to study patients to ensure understanding of proper medication dosage, administration and disease treatment.
- Documenting medical data in patient chart to ensure availability of timely records for decision making.
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines, including:
- Reviewing all regulatory requirements to ensure implementation of appropriate methods, practices, procedures, and protocols for all research activities in noted area.
- Completing all IRB required paperwork for studies.
- With the principal investigator, explaining the study purpose, parameters, and requirements of the studies to the participants.
Completes all tasks required by study sponsors, including:
- Providing regulatory documents to sponsor in timely manner.
- Completing case report forms for all study participants.
- Tracking and reporting adverse events.
- Coordinating research monitor visits.
- Reviews monthly financial reports, including study participant billing, expenditures, and revenue; Prepares budget analysis forms according to study protocol procedures.
- Participates in recruitment and selection of study participants by interviewing and reviewing medical history to determine compliance with eligibility requirements.
Coordinates the process for opening new studies, including:
- Obtaining needed background material(s) on proposed research projects; presenting findings and information to attending physician/principle investigator.
- Completing feasibility questionnaires.
- Circulating the confidentiality disclosure and trial agreements to the appropriate parties.
- Participates in a variety of professional development programs to ensure ongoing awareness and understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
- Performs miscellaneous job related duties as requested.