Work 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

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- Medical Program

Resume Max Pages- 3

Certifications & Licenses- Licensed physician or board eligible

Field of Study- Neuroscience

Software- Microsoft office - Outlook - CRIS - CTDB

Skills: - Clinical research - Medical training - Patient care - Risk management - Site visits - Regulatory - Human research subject protections - Subject recruitment/enrollment - Clinical protocol review

- Administrative summaries - Clinical trial oversight - Subject matter expert

Statement of Work Details

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.

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 participate in the resolution.
• 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 the suitability of volunteers for enrollment into a study, consult for protocol PIs, and assist in safety oversight/assessments.

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

• Guide 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.
• Provide subject matter expertise during protocol development.

Assists in developing protocols for future clinical projects.

• 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.

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

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

Evaluates various reports and safety monitoring plans and produce 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 implanting clinical trials.
• 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.

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.

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.
• 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.
• Serve as an expert medical resource to staff and investigators.
• Participate in clinical trial decision on the selection and implementation of interventions, review of clinical outcomes, and assurance of participant safety.

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 the 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 meetings, 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.