Position Objective: Provide services as a Medical Officer in support of the overall functions of the Clinical Center (CC) within the National Institutes of Health (NIH). The individual will serve as a Pediatric Physician with clinical research and patient care provision responsibilities including satisfying overall operational objectives of the Department of Pediatrics.
Duties and Responsibilities:
Monitor the status of project applications and awards from peer review through post-award administration; implement correctiveactions where there is inadequate progress or other problems.
Ensure that funded research is scientifically valid and complies with priorities. 3
Advise program management on merits and deficiencies of proposed clinical studies.
Review and provide recommendations on the design and safety of clinical trials that represent the Program in communication with stakeholders while developing and implementing clinical trials. 4
Participate in department standing meeting, training and safety related educational programs and efforts.
Establish goals and objectives for the assigned research area and organize efforts to initiate pioneering programs and resolve critical issues involving accomplishment of the research.
Provide guidance on IRB processes, pediatric clinical care, hospital pharmacy and hospital pharmacy communities.
Provide advice on the oversight of clinical trials and protocols.
Provide scientific and regulatory expertise in oncology drug development, symptom management and clinical oncology.
Administer clinical and basic research projects, including clinical trials; monitor progress and conduct of projects, including protection and safety of participants in clinical trials.
Review clinical trial protocols and provide comments as for safety and operational issues with protocols.
Perform periodic medical data review - review laboratory values, adverse events, coding documentaries and data tables, listing and figures as needed.
Identify process and implementation issues/gaps needing attention/remediation; manage their effective escalation and participates in the resolution.
Identify pivotal unanswered clinical questions in symptom management and amelioration of treatment related toxicity.
Evaluate progress of current clinical trials in symptom management.
Review, comment on, and accept or reject for clinical protocols for implementation.
Provide expertise for ongoing trials, including suitability of volunteers for enrollment into a study, consult for protocol PIs, and assist in safety oversight/assessments.
Function as a Pediatric Physician providing care and services to patients with clinical responsibility 2
Provide guidance on IRB and processes, clinical patient care, hospital pharmacy and hospital pharmacy communities.
Collaborate with staff on the review, planning and implementation of clinical trials and ensure all concerns are addressed.
Evaluate the hypothesis, objectives, study design, feasibility and regulatory requirements.
Provide subject matter expertise during protocol development.
Provide support for extramural research program, including epidemiologic studies, clinical trials and other basic and clinical studies.
Plan, implement, coordinate and evaluate programs and initiatives in the assigned specialty area of research.
Review and participate in the development of research initiatives, with emphasis on the importance and timeliness of the study question, soundness of its rationale, adequacy of design and feasibility.
Review data and progress reports; implement corrective actions needed to achieve adequate research progress. 1
Establish goals and objectives for the assigned research area and organize efforts to initiate pioneering programs and resolve critical issues involving accomplishment of the research.
Work with staff on protocol development; provide input on study safety design; identify medical and logistical problems that may impede the study; conduct reviews of clinical protocols and all supporting documents; and provide feedback to staff and clinical investigators.
Provide clinical expertise to assist in developing Investigational New Drug (IND) applications.
Participate in clinical trial decision on selection and implement of interventions, review of clinical outcomes, and assurance of participant safety. 5
Write policies and guidelines that impact patients enrolled in Institute-sponsored studies.
Formulate concepts to foster research in new of underdeveloped areas of research.
Formulate internal policies concerning Extramural research policy and priorities; advise management on the direction of research efforts.
Provide scientific and regulatory expertise in drug development for symptom management clinical trials.
Write policies and guidelines on safety related issues for research studies.
Provide a review and response to protocol amendments; write, review and edit materials following group discussion on research and scientific protocol.
Review pertinent literature to provide a scientifically rigorous review of the subject matter.
Review and provide recommendations on the design and safety of clinical trials that represent the Institute in communications with the FDA, sponsors and academia partners while developing and implanting clinical trials.
Write policies and guidelines that impact patients enrolled in sponsored studies.
Provide written scientific reports on specific symptom management topics as needed.
Participate in discussions of and prepare written summaries of evaluations of clinical trial concepts.
Provide oral and/or written reports and status updates of on-going projects.
Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.
Update and maintain patient and protocol records; prepare reports are required.
Write policies and guidelines on safety related issues for research studies.
Provide a review and response to protocol amendments; write, review and edit materials following group discussion on research and scientific protocol.
Review pertinent literature to provide a scientifically rigorous review of the subject matter.
Review and provide recommendations on the design and safety of clinical trials that represent the Institute in communications with the FDA, sponsors and academia partners while developing and implanting clinical trials.
Write policies and guidelines that impact patients enrolled in sponsored studies.
Provide written scientific reports on specific symptom management topics as needed.
Participate in discussions of and prepare written summaries of evaluations of clinical trial concepts.
Provide oral and/or written reports and status updates of on-going projects.
Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.
Update and maintain patient and protocol records; prepare reports are required.
Take part in site visits to review and assess medical issues.
Provide medical expertise in protocol follow-up stages for subject safety and protection.
Assess serious adverse events from clinical trials.
Review safety reports and represent the Program as a safety expert on safety committees.
Review reporting strategies (safety monitoring plans), incoming safety data (adverse event reporting, safety committee reports) clinical study reports.
Preview serious adverse event (SAE) reports; provide expert medical advice for potential impact of SAEs on ongoing research.
Provide comments regarding safety and operational issues with program-sponsored protocols.
Discuss clinical design and safety issues at various group meetings.
Participate in clinical trial Steering Committee decisions on selection and implementation of interventions, review of clinical outcomes and assurance of participant safety.
Review and provide recommendations on the design and safety of clinical trials that represent the Program in communication with stakeholders while developing and implementing clinical trials.
Review clinical trial protocols.
Advise program management on merits and deficiencies of proposed clinical studies.
Administer clinical and basic research projects, including clinical trials; monitor progress and conduct of projects, including protection and safety of participants in clinical trials.
Ensure that funded research is scientifically valid and complies with Institute/Center, NIH and DHHS priorities.
Monitor the status of project applications and awards from peer review through post-award administration; implement corrective actions where there is inadequate progress or other problems.
Review safety reports and represent the Program as a safety expert on safety committees.
Assess serious adverse events from clinical trials.
Provide medical expertise in protocol follow-up stages for subject safety and protection.
Preview serious adverse event (SAE) reports; provide expert medical advice for potential impact of SAEs on ongoing research.
Review reporting strategies (safety monitoring plans), incoming safety data (adverse event reporting, safety committee reports) clinical study reports.
Provide comments regarding safety and operational issues with program-sponsored protocols.
Provide advice on the oversight of clinical trials.
Provide clinical expertise to assist in developing Investigational New Drug (IND) applications.
Evaluate annual IND annual reports for medical safety; report findings.
Serve as an expert medical resource to staff and investigators.
Participate in clinical trial decision on selection and implement of interventions, review of clinical outcomes, and assurance of participant safety.
Write policies and guidelines that impact patients enrolled in Institute-sponsored studies. Formulate concepts to foster research in new of underdeveloped areas of research.
Formulate internal policies concerning Extramural research policy and priorities; advise management on the direction of research efforts.
Provide administrative actions on grant applications and funded projects; develop effective solutions to emerging or unforeseen challenges to program development of administration.
Establish goals and objectives for the assigned research area and organize efforts to initiate pioneering programs and resolve critical issues involving accomplishment of the research.
Review safety reports and represent the Program as a safety expert on safety committees.
Participate in department standing meeting, training and safety related educational programs and efforts.
Attend and participate in scientific meetings and conferences.
Serve as a medical liaison between the Institute/Center and research working groups.
Collaborate on the planning, development, implementation and administration of research and training programs, projects, and contracts, conferences and workshops.
Participate in clinical trial Steering Committee decisions on selection and implementation of interventions, review of clinical outcomes and assurance of participant safety.
Discuss clinical design and safety issues at various group meetings.
Qualifications
Basic Qualifications:
MD or DO required
Licensed physician or board eligible
Skilled Clinical Research, patient care, clinical processes and operational issues, writing/revising new clinical research protocols, and literature review
Experience with Ms Office Suite and Patient electronic medical records
Minimum Qualifications:
Ability to multi-task and pay close attention to detail.
Excellent analytical and interpersonal, organizational and time management skills.
Strong communication skills, both oral and written.
*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 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.
