Current jobs related to Physician - Bethesda - PriceSenz

Location: IC:NIMH Street: 10 Center Drive Bldg: 10 Clinical Center Room: 4C438 City: Bethesda State & Zip: MD20892

Weekly HoursPT: Less than 30 hours per week Total No. OfHours 20

Overall PositionSummary and Objectives

The positionwill independently provide support services to satisfy the overalloperational objectives of the National Institute of MentalHealth.

Min Education:Masters

Resume Max Pages:3

Certifications &Licenses

• Licensedphysician or board eligible

Skills (Ranked byPriority)

1. Clinicalresearch
2. Medical training
3. Patient care
4. Riskmanagement
5. Site visits
6. Regulatory
7. Human research subjectprotections
8. Subjectrecruitment/enrolment
9. Clinical protocolreview
10. Administrative summaries
11. Clinical trial oversight
12. Subjectmatter expert

1 2 3 4 5represents priority rankings where 1 is highestpriority and 5 is lowest priority of thoseranked

Software

• Microsoft office
• Outlook
• CRIS
• CTDB

Field of Study

• Neuroscience

Statement of Work Details

Provides executive experience needed to conductneeds assessments and develop recommendations for improvements ofcurrent operations.

• Provide analyses evaluations technical assessmentsfeedback and support in the planning and implementation ofactivities.
• Administer clinical and basicresearch projects including clinical trials; monitor progress andconduct of projects including protection and safety of participantsin clinical trials. 3
• Provide expertise for ongoing trials includingsuitability of volunteers for enrolment into a study consult forprotocol PIs and assist in safety oversight/assessments.4
• Reviews the clinicalprotocols for safety of the study; provide medical expertise inprotocol followup stages for subject safety and protection; assessserious adverse events from clinical trials.2
• Review safety reports andrepresent the Program as a safety expert on safety committees;Review reporting strategies (safety monitoring plans) incomingsafety data (adverse event reporting safety committee reports)clinical study reports.
• Provide medicalexpertise in protocol followup stages for subject safety andprotection 5
• Participate inclinical trial Steering Committee decisions on selection andimplementation of interventions review of clinical outcomes andassurance of participant safety; Discuss clinical design and safetyissues at various group meetings.

Collaborates with other professionals to developrecommendations for current and future initiatives.

• Evaluates various reports andsafety monitoring plans and produces detailed reports for use byupper clinic or laboratory management; Review and providerecommendations on the design and safety of clinical trials thatrepresent the Institute in communications with the FDA sponsors andacademia partners while developing and implementing clinicaltrials.
• Assess serious adverse events fromclinical trials; Preview serious adverse event (SAE) reports;provide expert medical advice for potential impact of SAEs onongoing research.
• Assists in developingprotocols 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 forimplementation.
• Identify process andimplementation issues/gaps needing attention/remediation; managetheir effective escalation and participates in theresolution.

Advisesmanagement and staff on formulation of new strategies and sensitiveor complicated issues.

• Provide expert medical advice for potential impact ofSAEs on ongoing research; Provide comments regarding safety andoperational issues with programsponsored protocols.
• Ensure that funded research is scientifically valid andcomplies with Institute/Center NIH and DHHS priorities; Monitor thestatus of project applications and awards from peer review throughpostaward administration; implement corrective actions where thereis inadequate progress or other problems.
• Reviews safety reports and provides recommendations forimprovement.
• Coordinates all aspects ofclinical protocol development review and implementation; Adviseprogram management on merits and deficiencies of proposed clinicalstudies; Participate in department standing meeting training andsafety related educational programs and efforts; Provide advice onthe oversight of clinical trials and protocols.
• Coordinates and participates in various meetings trainingand safetyrelated educational programs; Review safety reports andrepresent the Program as a safety expert on safety committees;Participate in department standing meeting training and safetyrelated educational programs and efforts; Attend and participate inscientific meetings and conferences; Serve as a medical liaisonbetween the Institute/Center and research workinggroups.

Works with staffto develop and implement new and proactive programs geared tospecific audiences.

• Discuss clinical design and safety issues at variousgroup meetings.
• Participate in discussions ofand prepare written summaries of evaluations of clinical trialconcepts; Provide oral and/or written reports and status updates ofongoing projects; Update and maintain patient and protocol records;prepare reports are required.
• Provide guidanceon IRB and processes clinical patient care hospital pharmacy andhospital pharmacy communities. 1
• Collaborate with staff on the review planning andimplementation of clinical trials and ensure all concerns areaddressed.
• Collaborate on the planningdevelopment implementation and administration of research andtraining programs projects and contracts conferences andworkshops.

Conductsresearch and analysis to proactively address and respond toinquiries on various policies and issues.

• Write policies and guidelines on safetyrelated issues for research studies.
• Participate in clinical trial decision on selection andimplement of interventions review of clinical outcomes andassurance of participant safety; Formulate concepts to fosterresearch in new of underdeveloped areas of research.
• Evaluates existing protocols and provides suggestions fordesign execution and improvement; Provide subject matter expertiseduring protocol development.
• Review andprovide recommendations on the design and safety of clinical trialsthat represent the Program in communication with stakeholders whiledeveloping and implementing clinical trials; Review clinical trialprotocols; Advise program management on merits and deficiencies ofproposed clinical studies.; Administer clinical and basic researchprojects including clinical trials; monitor progress and conduct ofprojects including protection and safety of participants inclinical trials.
• Review clinical trialprotocols and provide comments as for safety and operational issueswith protocols; Perform periodic medical data review reviewlaboratory values adverse events coding documentaries and datatables listing and figures as needed.
• Developspolicies and guidelines; Establish goals and objectives for theassigned research area and organize efforts to initiate pioneeringprograms and resolve critical issues involving accomplishment ofthe research.

Coordinatesand advances professional development and research done by othersin areas where other mechanisms may not be optimal due to timeconstraints or other issues.

• Provide facilitation and training for staff.
• Provides advice and guidance for all clinicaltrials.
• Provides guidance to staff on variousclinical processes and operational issues; Provide commentsregarding safety and operational issues with programsponsoredprotocols; Provide advice on the oversight of clinicaltrials.
• Provide clinical expertise to assistin developing Investigational New Drug (IND) applications; Serve asan expert medical resource to staff and investigators; Participatein clinical trial decision on selection and implement ofinterventions review of clinical outcomes and assurance ofparticipant safety.