Staff Clinician

Statement of Work Details

Coordinates all aspects of clinical protocol development review and implementation.

• Participate in department standing meeting training and safety related educational programs and efforts.
• 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. 1

Monitors ongoing clinical studies and clinical trials.

• Review clinical trial protocols and provide comments as for safety and operational issues with protocols.

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

• Collaborate with staff on the review planning and implementation of clinical trials and ensure all concerns are addressed.
• Evaluate the hypothesis objectives study design feasibility and regulatory requirements.
• Provide subject matter expertise during protocol development.
• Review and participate in the development of research initiatives with emphasis on the importance and timeliness of the study question soundness of its rationale adequacy of design and feasibility.
• Review data and progress reports; implement corrective actions needed to achieve adequate research progress.
• 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. 2
• Work with staff on protocol development; provide input on study safety design; identify medical and logistical problems that may impede the study; conduct reviews of clinical protocols and all supporting documents; and provide feedback to staff and clinical investigators.

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. 4

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

• Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication. 3

Evaluates various reports and safety monitoring plans and produces detailed reports for use by upper clinic or laboratory management.

• Provide a review and response to protocol amendments; write review and edit materials following group discussion on research and scientific protocol.
• Review pertinent literature to provide a scientifically rigorous review of the subject matter.
• Provide oral and/or written reports and status updates of on-going projects.
• Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.

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.
• 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.

Reviews safety reports and provides recommendations for improvement.

• Provide medical expertise in protocol follow-up stages for subject safety and protection.

Provides guidance to staff on various clinical processes and operational issues. - Serve as an expert medical resource to staff and investigators.

• Play a major educational role in the organization and implementation of the University of Maryland NIH combined GI fellowship training program

Develops policies and guidelines.

• Formulate concepts to foster research in new of underdeveloped areas of research.
• 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 participates in various meetings training and safety-related educational programs.

• Collaborate 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.