Medical Officer 2 - 3

Position Requirements

Overall Position Summary and Objectives To provide guidance on the background justification for the scientific objectives and medical safety of the trials supported by CTEP, the interaction between the regulatory aspects of clinical trial agreements and terms for trials with pharmaceutical collaborators and extramural investigators, and comment on the content and provide feedback on specific concerns by the extramural investigators as well as the extramural sites subject to the medical/scientific and policy requirements of the specific CTEP-supported clinical trials that they participate in. In addition, this physician consultant may offer guidance on other DCTD initiatives that affect its clinical trials network programs.

Min Education: Medical Program

Resume Max Pages: 3

Additional Qualifications

Certifications & Licenses

- Licensed physician or board eligible - Board Certified in Oncology

Field of Study

- General Medical and Health Services

Software

- Microsoft office - SharePoint - Outlook

Skills

- Clinical research - Expertise in clinical trial design and conduct, especially with respect to biomarker-driven, precision medicine oncology treatment trials - Expertise in FDA regulatory requirements related to conduct of clinical treatment trials in oncology preferred. - Must possess knowledge and expertise in the drug development process and policies - Must possess extensive experience in reviewing pre-clinical and clinical research data supporting the research objectives in clinical treatment trials in oncology - Medical training - Data management - Oncology Experience required.

Statement of Work Details

Coordinates all aspects of clinical protocol development, review and implementation.

Review and provide comments on clinical trial proposals or modifications to approved or active CTEP-funded trials as requested.

Collaborate with CTEP staff to train and assist staff on the design and conduct of clinical treatment trials in oncology.

Provide scientific and regulatory expertise in oncology drug development, symptom management and clinical oncology.

Monitors ongoing clinical studies and clinical trials.

Provide expert guidance on CTEP regulatory guidelines for clinical trials. 1

Review clinical trial protocols and provide comments as for safety and operational issues with protocols.

Review, comment on, and accept or reject for clinical protocols for implementation.

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

Collaborate with staff on the review, planning and implementation of clinical trials and ensure all concerns are addressed. 3

Provide subject matter expertise during protocol development.

Provide support for extramural research program, including epidemiologic studies, clinical trials and other basic and clinical studies.

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. 2

Participate in clinical trial decision on selection and implement of interventions, review of clinical outcomes, and assurance of participant safety.

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.

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.

Participate in discussions of and prepare written summaries of evaluations of clinical trial concepts.

Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.

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.

Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.

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.

Preview serious adverse event (SAE) reports; provide expert medical advice for potential impact of SAEs on ongoing research.

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 stakeholders while developing and implementing clinical trials.

Review clinical trial protocols.

Advise program management on merits and deficiencies of proposed clinical studies. 4

Administer clinical and basic research projects, including clinical trials; monitor progress and conduct of projects, including protection and safety of participants in clinical trials.

Reviews safety reports and provides recommendations for improvement.

Assess serious adverse events from clinical trials. 5

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.

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

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.

Provide administrative actions on grant applications and funded projects; develop effective solutions to emerging or unforeseen challenges to program development of administration.

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

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.

Attend and participate in scientific meetings and conferences.

Deliverables

Work products and documents related to managing and coordinating standard operating procedures across CTEP related to the efficient and effective conduct of CTEP-supported clinical trials. - Ad-Hoc

Work products and documents related to setting new guidelines and standards for conduct of clinical trials. - Ad-Hoc

Work products and documents related to ongoing decision-making to facilitate optimal progress of trials; provide advice and guidance to scientists, pharmacists, informaticians that will assist them in assuring a well-coordinated and optimally functioning clinical trials support service for the conduct of CTEP-supported clinical trials. - Ad-Hoc

Work products and documents related to development of an online site that captures, maintains and updates all the pertinent CTEP Branch SOPs for the conduct of clinical trials. - Ad-Hoc

Physical Requirements

Does this position require enrollment in the NIH Bio surety Program? Does this position have clinical responsibilities that involve direct patient care?

No No

Will the individual be required to:

Lift or carry more than 50 pounds Lift or carry 25-50 pounds Lift or carry less than 25 pounds Push or pull more than 45 pounds Push or pull 25-45 pounds Reach above shoulder level

No No No No No No

Push or pull less than 25 pounds Stand or walk more than 25 of 30 min Bend repeatedly Kneel Crawl Climb

No No No No No No

Have correctable near vision Distinguish basic colors Operate a motor vehicle Perform repetitive activities Have depth perception Use both hands

No No No Yes No Yes

Will the individual be working:

Alone Closely with others Outside In dust In excessive heat In excessive cold In excessive noise

Yes Yes No No No No No

Shifts Protracted or irregular Hours On slippery or uneven working surfaces On ladders or scaffolding Around machinery with moving parts With hands in water With solvents

No No No No No No No

Will the individual be in contact with any of the following:

Asbestos High noise levels Small animals

(fish, birds, rodents etc.)

Large animals (cats, dogs, sheep etc.) Non-Human

primates (rhesus, cynos etc.)

NonHuman

primate

Radiation Human blood or other body fluids Patient/

Human

subjects

Lasers (Open or Closed)

tissues

No No No No No No No No No No

Will the individual have contact with any of the following:

HIV-1 HIV-2 HTLV I/II MMR Viruses Rabies Virus SIV Taxoplasmosis Varicella Virus Orthopox Virus

No No No No No No No No No

Will the individual have contact with any of the following:

Aerosols Biological Inhalants Corrosive Substances Inorganic dusts and powders Insecti/Herbi/ Pesticides Other Plastics Heavy Metals Petroleu

m

products

Solvent s Sensitizing Agents

No No No No No No No No No No No

Will the individual have contact with any of the following:

B.Antharcis Botulinum N-toxin Ebola Virus F.talarensis Monkeypox

Virus

Ricin Yersinia Pets Other

No No No No No No No No

Will the individual have contact with any of the following Tier1 Select Agents:

Gloves Face

shields/ goggles

Safety Glasses Safety Shoes Lab Coat Ear plugs/ muffs Impervious suit Disposable dust/surgical masks Respirator Clean Room Uniform

No No No No No No No No No No

Job Type: Contract

Pay: From $30.00 per hour

Expected hours: No more than 40 per week

Benefits:

• Employee discount
• Health insurance

Medical specialties:

• Cardiology

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Rockville, MD 20850: Reliably commute or planning to relocate before starting work (Required)

License/Certification:

• BC/BE (Preferred)
• Medical License (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: In person