Physician

Job Description: (ID: 2024-5256) Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Physician to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Mental Health (NIMH) located in Bethesda, MD. Benefits We Offer:100% Medical, Dental & Vision Coverage for EmployeesPaid Time Off and Paid Holidays401K match up to 5%Educational Benefits for Career GrowthEmployee Referral Bonus Flexible Spending Accounts:Healthcare (FSA)Parking Reimbursement Account (PRK)Dependent Care Assistant Program (DCAP)Transportation Reimbursement Account (TRN) 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. Deliverables: 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. - Ad-HocWork 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. - Ad-HocWork 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. - Ad-HocWorks 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. - Ad-HocWork 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. - Ad-HocWork 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. - Ad-HocWork 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. - Ad-HocWork products and documents related to reviewing safety reports 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. - Ad-HocWork 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. - Ad-HocWorks 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. - Ad-Hoc Work Details: Provide guidance on IRB and processes, clinical patient care, hospital pharmacy and hospital pharmacy communities. 1Reviews 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. 2Administer clinical and basic research projects, including clinical trials; monitor progress and conduct of projects, including protection and safety of participants in clinical trials. 3Provide expertise for ongoing trials, including suitability of volunteers for enrollment into a study, consult for protocol PIs, and assist in safety oversight/assessments. 4Provide medical expertise in protocol follow-up stages for subject safety and protection 5Provides 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.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.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 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.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 on-going projects; Update and maintain patient and protocol records; prepare reports are required.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 inquires 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 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. 1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked Minimum Education Masters Additional Qualifications: Certifications & LicensesLicensed physician or board eligible Field of StudyNeuroscience SoftwareMicrosoft officeOutlookCRISCTDB SkillsClinical researchMedical trainingPatient careRisk managementSite visitsRegulatoryHuman research subject protectionsSubject recruitment/enrollmentClinical protocol reviewAdministrative summariesClinical trial oversightSubject matter expert Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed. The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those wh