Concentric Methods is seeking a Clinical Advisor to join our ream in Bethesda, MD in support of the NIH.
Oversee all aspects of participant study outpatient visits and inpatient admissions.
Communicate with potential participants and screen for eligibility for study.
Obtain and review potential participant medical records and history to determine eligibility.
Schedule participant visits and coordinate travel and housing for participants.
Coordinate participant schedule, consultations, and imaging appointments.
Ensure safe handling of various specimens in accordance with prescribed protocols.
Review patient care policies and procedures utilizing NIH guidelines as it relates to patient admissions.
Maintain appropriate research records in CRIS.
Consent and maintain research documents for participants.
Coordinate recruitment, consent, and specimens for mail-in biologic specimens.
Communicate and collaborate with the Principal Investigator and multidisciplinary research team to ensure that patient management strategies are successful in meeting patient care and research needs.
Communicate with participants, their caregivers, and physicians regarding appointments, laboratory findings, and imaging results, and management plan as needed.
Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
Contribute to the design, methodology, implementation, and regulatory review of specific protocols as assigned.
Coordinate multi-site IRB protocol in which NIH is the IRB of record including maintaining participant logs in coordination with other sites.
Coordinate single-site IRB protocols at NIH.
Assure that all procedures are being carried out per protocol.
Collect and ensure that sample volumes collected are within protocol limits.
Observe and ensure the safety of human subjects while procedures are being performed.
Create participant logs and monthly and annual reports for open studies.
Manage IRB review cycle submissions, including initial review, continuing review, amendments, and reports in accordance with IRB, NIH and other applicable regulations.
Contribute to the design, methodology, implementation, and regulatory review of research protocols, including informed consents, manual of operating procedures, and SOPs.
Understand Good Clinical Practices and federal human subjects research regulatory requirements and ensure compliance of research protocols with relevant requirements.
Coordinate with the IRB, Office of Human Research Protection, and other regulatory authorities at NIH and other sites as needed.
Respond to inquiries and audits from regulatory agencies, including researching the issues, assembling documentation, and preparing written responses.
Train staff and site investigators on regulatory requirements, including but not limited to IRB processes, informed consent, and adverse event reporting.
Survey the medical literature for background information on specific aspects of the diseases under purview.
Organize research information for clinical projects.
Create and review sample submission forms for accuracy prior to database entry.
Create and maintain database of clinical information for use in clinical research studies.
Create data collection forms for research studies and collect relevant data.
Provide a detail-oriented approach, able to work independently and efficiently to track multiple deadlines and keep projects on target and moving forward.
Anticipate and identify problems, consider alternatives, and work collaboratively and creatively to solve problems.