Medical Officer

Certifications & Licenses - Licensed physician or board eligible

Field of Study - General Medical and Health Services

Software - Microsoft office - Patient Electronic Medical Records - Outlook

Skills

- Clinical research

- Patient care

- clinical processes and operational issues

- writing/revising new clinical research protocols

- Literature review

Statement of Work Details

Coordinates all aspects of clinical protocol development review and implementation.

• 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 stake holders 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.

Monitors ongoing clinical studies and clinical trials.

• 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 assistin safety oversight/assessments.
• Function as a Pediatric Physician providing care and services to patients with clinical responsibility 2

Evaluates existing protocols and provides suggestions for design execution and improvement.

• 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.

Assists in developing protocols for future clinical projects.

• 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.

Produces various detailed reports for use by upper clinic or laboratory management.

• Write policies and guidelines on safety related issues for research studies
• 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.

Evaluates various reports and safety monitoring plans and produces detailed reports for use by upper clinic or laboratory management.

• 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.

Participates in site visits as needed.

• Take part in site visits to review and assess medical issues.

Reviews the clinical protocols for safety of the study.

• 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.

Provides advice and guidance for all clinical trials.

• Review and provide recommendations on the design and safety of clinical trials that represent the Program in communication with stake holders 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.

Reviews safety reports and provides recommendations for improvement.

• 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.

Provides guidance to staff on various clinical processes and operational issues.

• 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.

Develops policies and guidelines.

• 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.

Coordinates and participates in various meetings training and safety-related educational programs.

• 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.