Clinical Advisor

Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Laboratory of Immune System Biology (LISB), Division of Intramural Research (DIR) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• 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 assist the Federal Task Leader 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.
• Ensure that all procedures are being carried out per protocol.
• Collect and ensure that sample volumes collected are within protocol limits.
• Assist and ensure the safety of human subjects while procedures are being performed.
• Create participant logs and monthly and annual reports for open studies.
• Assist IRB review cycle submissions, including initial review, continuing review, amendments, and reports in accordance with IRB, NIH and other applicable regulations.
• Assist with the design, methodology, implementation, and regulatory review of research protocols, including informed consents, manual of operating procedures, and SOP's.
• Practice and follow 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.
• 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.

Basic Qualifications:

• Bachelor's degree or higher
• Minimum of two (2) years of related work experience is required.
• Must be able to be credentialed by the NIH Clinical Center.
• Knowledge pertaining to privacy of the patient, privileged information, and secure handling of the patient's medical records.
• Must complete all security and training for use of NIH databases and software and must follow and adhere to PII regulations.
• Experience using Microsoft Office products including Outlook, Sharepoint, MS Teams.

Minimum Qualifications:

• Professional verbal and written communication.
• Ability and willingness to work on a team.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.