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Position Objective: The Physician will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH).

Duties and Responsibilities:

• 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 enrollment 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 follow-up 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 follow-up 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.

• 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.

• Provide expert medical advice for potential impact of SAEs on ongoing research; Provide comments regarding safety and operational issues with program-sponsored 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 post-award 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 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.

• 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 on-going 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.

• 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.

• 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 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 selection and implement of interventions, review of clinical outcomes, and assurance of participant safety.

• Work products and documents related to coordinating all aspects of clinical protocol development, review and implementation; provide advice on the oversight of clinical trials and protocols; participates in department meetings; advise program management on merits and deficiencies of proposed clinical studies.

• Work products and documents related to monitoring ongoing clinical studies and clinical trials; administers clinical and basic research projects, including clinical trial; 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; identifies process and implementation issues/gaps needing attention/remediation; evaluate progress of current clinical trials; provide expertise for ongoing trials.

• Work products and documents related to evaluating existing protocols and providing suggestions for design, execution and improvement; Provides guidance on IRB and processes, clinical patient care, hospital pharmacies and hospital pharmacy communities; collaborate with staff on the review , planning and implementation of clinical trials and ensures all concerns are addressed; provide subject matter expertise during protocol development.

• Works products and documents related to assisting in developing protocols for future clinical projects; participates in clinical trial decision on selection and implement of interventions, review of clinical outcomes, and assurance of participant safety; formulated concepted to foster research in new of underdeveloped areas of research; participates in site visits when needed.

• Work products and documents related to producing 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 FDA, sponsors and academia partners while developing and implanting clinical trials; participated in discussions of and prepared written summaries of evaluations of clinical trial concepts; provide oral and/or written reports and status updates of on-going projects; updates and maintains patient and protocol records.

• Work products and documents related to reviewing the clinical protocols for safety of the study; provides medical expertise in protocol follow-up stages for subject safety and protection; assesses serious adverse events from clinical trials; reviews safety reports and represents the program as a safety expert on safety committees; reviews reporting strategies (safety monitoring plans), incoming safety data (adverse event reporting, safety committee reports) clinical study reports; previews serious adverse event reports; provides comments regarding safety and operational issues with program sponsored protocols; discusses clinical design and safety issues at various group meetings.

• Work products and documents related to providing advice and guidance for all clinical trials; review and provides recommendations on the design and safety of clinical trials; reviews clinical trial protocols; advises program management on merits and deficiencies of proposed clinical studies; administer clinical and basic research projects; ensure that funded research is scientifically valid and complies with Institute/Center, NIH and DHHS priorities; monitors the status of project applications and awards from peer review through post award administrations.

• Work products and documents related to reviewing safety report and providing recommendations for improvement; reviews safety reports; assesses serious adverse events from clinical trials; provide medical expertise in protocol follow-up stages for subject safety and protection; previews serious adverse event reports; reviews reporting strategies clinical study reports.

• Work products and documents related to providing guidance to staff on various clinical processes and operational issues; provide comments regarding safety and operational issued with program sponsored protocols; provide advice on the oversight of clinical trials; provides clinical expertise to assist in developing Investigational New Drug (IND) applications; serves as an expert medical resource; participated in clinical trial decision on selection and implement of interventions, reviews clinical outcomes and assurance of participant study.

• Works products and documents related to developing policies and guidelines; coordinates and participated in various meeting, training and safety related educational programs; reviews safety reports; participated in department standing meetings; attend and participated in scientific meetings; serves as medical liaison; collaborates on the planning, development, implementation and administration of research and training programs, projects and contracts, conferences and workshops; discuss clinical design and safety issues at various group meetings.

Qualifications

Basic Qualifications:

• M.D. required

• Licensed physician or board eligible

• Skilled in clinical research, medical training, patient care, risk management, and site visits.

• Skilled in regulatory, human research subject protections, subject recruitment/enrollment, and clinical protocol review

• Experience in administrative summaries, clinical trial oversight, and subject matter expert

• Experience with CRIS, CTDB, MS Office Suite, Outlook

Preferred Qualifications:

• Strong communication skills, both oral and written

• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*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.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.