This position independently coordinates and is accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. This position is responsible for coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides 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, regulatory agency, and specific institutional requirements. This position provides mentorship and training to lower-level clinical research staff and/or support personnel; works on departmental projects; and contributes to change implementation in the department.
- 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.
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties.
- Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
- Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis
- Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors
- With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants
Completes all tasks required by study sponsors.
- Provides regulatory documents to sponsor in timely manner
- Completes case report forms, data entry, and maintains source documentation for all study participants
- Tracks and reports adverse events per sponsor and institutional guidelines
- Coordinates research monitor visits and responds to all data queries
Coordinates the process for opening new studies.
- Obtains needed background material(s) on proposed research projects; presents findings and information to principle investigator
- Completes feasibility questionnaires
- Circulates the confidentiality disclosure and trial agreements to the appropriate parties
- Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial.
- Develops work flow procedures for study team based on specific protocol
- Participates in recruitment and selection of study participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
- Coordinates and schedules a variety of medical procedures/tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol(s).
- In conjunction with the principal investigator, research pharmacist, and other members of the research study team, provides study specific education to the participant and their family. This may include study specific procedures, diary/study log documentation, proper dosage/administration, and disease treatment.
- Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
- Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
Provides training/mentoring as well as process and policy development feedback
- Provides training and mentoring to PCH Clinical Research Nurses, Clinical Research Coordinators, and Research Assistants under the supervision of the Manager, Clinical Research Operations
- Provides feedback during the process of changing, updating, or developing new policies and procedures in the research department. Works with management to implement new policies and procedures throughout the department and institution and works on special projects as requested.
- Performs miscellaneous job related duties as requested.