Physician

Location: IC: NIMH Street: 10 Center Drive Bldg: 10 Clinical Center Room: 4C438 City: Bethesda State & Zip: MD 20892

Weekly Hours PT: Less than 30 hours per week Total No. Of Hours 20

Overall Position Summary and Objectives

The position will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health.

Min Education: Masters

Resume Max Pages: 3

Certifications & Licenses

• Licensed physician or board eligible

Skills (Ranked by Priority)

1. Clinical research
2. Medical training
3. Patient care
4. Risk management
5. Site visits
6. Regulatory
7. Human research subject protections
8. Subject recruitment/enrolment
9. Clinical protocol review
10. Administrative summaries
11. Clinical trial oversight
12. Subject matter expert

1 2 3 4 5 represents priority rankings where 1 is highest priority and 5 is lowest priority of those ranked

Software

• Microsoft office
• Outlook
• CRIS
• CTDB

Field of Study

• Neuroscience

Statement of Work Details

Provides executive experience needed to conduct needs assessments and develop recommendations for improvements of current operations.

• Provide analyses evaluations technical assessments feedback and support in the planning and implementation of activities.
• Administer clinical and basic research projects including clinical trials; monitor progress and conduct of projects including protection and safety of participants in clinical trials. 3
• Provide expertise for ongoing trials including suitability of volunteers for enrolment into a study consult for protocol PIs and assist in safety oversight/assessments. 4
• Reviews the clinical protocols for safety of the study; provide medical expertise in protocol followup stages for subject safety and protection; assess serious adverse events from clinical trials. 2
• 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.
• Provide medical expertise in protocol followup stages for subject safety and protection 5
• 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.

Collaborates with other professionals to develop recommendations for current and future initiatives.

• Evaluates various reports and safety monitoring plans and produces detailed reports for use by upper clinic or laboratory management; 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 implementing clinical trials.
• Assess serious adverse events from clinical trials; Preview serious adverse event (SAE) reports; provide expert medical advice for potential impact of SAEs on ongoing research.
• Assists in developing protocols for future clinical projects.
• Monitors ongoing clinical studies and clinical trials; Evaluate progress of current clinical trials in symptom management. Review comment on and accept or reject for clinical protocols for implementation.
• Identify process and implementation issues/gaps needing attention/remediation; manage their effective escalation and participates in the resolution.

Advises management and staff on formulation of new strategies and sensitive or complicated issues.

• Provide expert medical advice for potential impact of SAEs on ongoing research; Provide comments regarding safety and operational issues with programsponsored protocols.
• 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 postaward administration; implement corrective actions where there is inadequate progress or other problems.
• Reviews safety reports and provides recommendations for improvement.
• Coordinates all aspects of clinical protocol development review and implementation; Advise program management on merits and deficiencies of proposed clinical studies; Participate in department standing meeting training and safety related educational programs and efforts; Provide advice on the oversight of clinical trials and protocols.
• Coordinates and participates in various meetings training and safetyrelated 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.

Works with staff to develop and implement new and proactive programs geared to specific audiences.

• Discuss clinical design and safety issues at various group meetings.
• Participate in discussions of and prepare written summaries of evaluations of clinical trial concepts; Provide oral and/or written reports and status updates of ongoing projects; Update and maintain patient and protocol records; prepare reports are required.
• Provide guidance on IRB and processes clinical patient care hospital pharmacy and hospital pharmacy communities. 1
• Collaborate with staff on the review planning and implementation of clinical trials and ensure all concerns are addressed.
• Collaborate on the planning development implementation and administration of research and training programs projects and contracts conferences and workshops.

Conducts research and analysis to proactively address and respond to inquiries on various policies and issues.

• Write policies and guidelines on safety related issues for research studies.
• Participate in clinical trial decision on selection and implement of interventions review of clinical outcomes and assurance of participant safety; Formulate concepts to foster research in new of underdeveloped areas of research.
• Evaluates existing protocols and provides suggestions for design execution and improvement; Provide subject matter expertise during protocol development.
• 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.
• 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.
• Develops policies and guidelines; 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 advances professional development and research done by others in areas where other mechanisms may not be optimal due to time constraints or other issues.

• Provide facilitation and training for staff.
• Provides advice and guidance for all clinical trials.
• Provides guidance to staff on various clinical processes and operational issues; Provide comments regarding safety and operational issues with programsponsored protocols; Provide advice on the oversight of clinical trials.
• Provide clinical expertise to assist in developing Investigational New Drug (IND) applications; 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.