Research Coordinator II, Administrative Research

Inspire health. Serve with compassion. Be the difference.

Responsible for the implementation, management and oversight of clinical trial research studies including the education of research staff, healthcare team members, participants and their caregivers. Registers, compiles, submits and oversees clinical data, monitors study compliance and maintains a system for effective data flow for patients on clinical trials. Manages patient visits and implements protocol related procedures. Responsible for monitoring and communicating study participant progress and safety issues with the investigators, applicable regulatory agencies, health care team and study staff.

• All team members are expected to be knowledgeable and compliant with Prisma Health's values:
  Inspire health. Serve with compassion. Be the difference.
• Assists in determining patient eligibility for enrollment in research studies. Identifies individual patient needs to facilitate participation including identifying and pre-screening potential participants. Registers patients into research studies to meet protocol parameters. Assists MD investigator in the informed consent process.
• Provides coordination over assigned research staff. Ensures assigned study staff practice within the parameters of their qualifications and collaborates with team members for optimal functioning of the unit/department. Trains and oversees personnel managing studies and regulatory matters.
• Collaborates with other health team members to formulate an interdisciplinary plan of care and plans a schedule of patient activities related to the study requirements. Instructs participating health care team members in clinical trials procedures, and orients health care professionals to the clinical studies program. Interacts with other members of health team to monitor protocol compliance and to ensure that the assigned patient care needs are met.
• Identifies specific learning needs and abilities of patients/families to provide appropriate education at the level of the recipient. Provides patients/families with information regarding clinical trial participation and provides education regarding individual treatment including purpose, potential side effects, and self-care measures, documents interaction. Maintains patient privacy per institutional and study related policies.
• Gathers and abstracts study data and documents in a factual, concise manner which meets regulatory/unit standards. Achieves, timely, thorough and accurate completion and evaluation of case report forms. Reviews records/forms for compliance with protocol requirements. Prepares for and manages pre-site, study initiation, interim monitoring, and close-out visits. Assists investigator in the completion of data queries. Gathers records, reports, lab results, radiographs, scans and other materials required for institutional, sponsor and FDA audits.
• Collaborates with Prisma Health Research services, including the CRMO, IRB and OSP and sponsoring agencies as well as local agencies, when applicable, to ensure global awareness regarding the progression of various studies, amendments and regulatory monitoring. Attends Investigator Meetings as appropriate. Prepares and presents lectures and/or written materials for health care provider education and participates in presentations or seminars related to the research study when necessary.
• Manages study related inventory including data collection tools, study supplies and study medication, if applicable. Schedules visits with the sponsoring agencies.
• Assists department manager/supervisor to coordinate resources to appropriately conduct the trial including the development of data collection tools, communication with ancillary departments to implement study related procedures. Collaborates with study team to develop new strategies for the growth of the Research program. Communicates study related issues with research management.
• Assists investigator in the development of investigator-initiated research studies including the development of protocols, literature searches, and data collection tools as well as assistance in the submission of…