Medical Officer (Clinical Program Manager)

Eagle Health is seeking a Medical Officer to support the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

1.General Tasks:

• Work as the REI Fellowship Director; This would include an additional 3rd training site: NIH/Walter Reed/Shady Grove
• Work with fellows and supervise activities during their time at NIH
• Meet with Joyce Chung (in her role as ACGME director for the NIH Clinical Center)
• Meet with NICHD Clinical Director (as an administrative contact for REI fellows)
• Provide feedback for the PMAP of 6 civilian fellows (2 per year) working with FTL, Dr. Gordon
• Attend clinical meetings - in-person and virtual - that are of relevance to the REI fellowship(monthly OCD Clinical Staff meeting, weekly teaching conference, etc).
• Active contributions in current FY to mentorship, as demonstrated by mentoring of less experienced trainees students or other staff.
• Demonstration of a research by clinical fellows that supports the NICHD mission:
• High quality basic, translational, or clinical research focus
• Takes advantage of the unique aspects of the NIH intramural environment
• Actively and dependably promote a culture of quality patient care and safety.
• Direct or indirect clinical services of any form are regularly delivered in a safe, effective, and patient centered manner.
• Conducts weekly reviews with the clinical research team to identify problems and other events requiring reporting to the IRB, study sponsor, or both.
• Submits reports of all reportable events and problems to the IRB, study sponsor, or both according to applicable reporting timelines.
• Ensures all personnel are compliant with annual lab safety training requirements and wear the proper attire in the clinic including a lab coat (as appropriate).

2.Coordinates all aspects of clinical protocol development, review and implementation, with a focus on the work of the REI fellows.

• 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.
• Ensure that funded research is scientifically valid and complies with priorities.
• Advise program management on merits and deficiencies of proposed clinical studies.
• 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.
• 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.
• Provide guidance on IRB processes, pediatric clinical care, hospital pharmacy and hospital pharmacy communities.
• Provide advice on the oversight of clinical trials and protocols.
• Provide scientific and regulatory expertise in oncology drug development, symptom management and clinical oncology.

3.Monitors ongoing clinical studies and clinical trials that represent the involvement of the REI fellows.

• 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 participates in the resolution.
• Identify pivotal unanswered clinical questions in symptom management and amelioration of treatment related toxicity.
• 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 suitability of volunteers for enrollment into a study, consult for protocol PIs, and assist in safety oversight/assessments.

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

• Provide guidance on 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.
• Evaluate the hypothesis, objectives, study design, feasibility and regulatory requirements.
• Provide subject matter expertise during protocol development.
• Provide support for extramural research program, including epidemiologic studies, clinical trials and other basic and clinical studies.
• Plan, implement, coordinate and evaluate programs and initiatives in the assigned specialty area of research.
• 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.
• 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

5.Reviews, assesses, and evaluates clinical trial design and feasibility.

• Assists fellows in reviewing clinical trial requests or opportunities, and selecting, designing and planning for their studies.
• Assists fellows in developing clinical trial and other study protocols, including determining objectives, design, methodology, statistical considerations and organization of the study.
• Develops and delivers recommendations and changes to clinical protocols to improve the overall effectiveness of the study. Review protocol and consent changes, as well as other implementation and operations procedures as necessary.
• Assist fellows in implementing and monitor clinical trials, collecting data and preparing project updates, status reports and summaries of results.
• Assist fellows in developing project schedules, quality assurance plans and budgets in accordance with stakeholder expectations.

6.Reviews, evaluates and analyzes clinical trial data and study information.

• Gather, interpret, synthesize, and analyze clinical trial data for inclusion in a variety of documents and reports.
• Assists researchers to monitor project schedules and track financial support.
• Create data collection plans and provide regular written reports detailing progress against tasks and milestones.
• Provide periodic progress reports that include updated status and progress on the contracted tasks.
• Develop and implement a system to track, abstract, and follow up on budgets.

7.Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation.

• Review requests and proposals from external institutions for collaborations and use of materials.
• Provide expert advice to the staff regarding project management support to clinical relevance and clinical data analysis trials, including scheduling, resource and budget management and reporting. Provide scientific and administrative project management support.
• Identify and monitor clinical trial risks. Manage project risk by proactively anticipating issues and develop contingency plans and solutions.
• Coordinate with program management staff on clinical trial project schedules, resource, budgets, and tracking.
• Assist researchers to develop frequently asked questions and other informational and guidance documents.

8.Assesses and supports meetings and clinical trial/study assessments.

• Attend and participate in specific meetings related to clinical trials and assist researchers gather information and report status.
• Support clinic in-person and teleconferences and steering and publication committee calls to review scientific proposals, data and publications.
• Attend site initiation visits, site qualifying visits and protocol start-up meetings to gather information and make recommendations.
• Attend and participate in U.S scientific meetings and conferences of professional societies and clinical organizations.
• Assist fellows to monitor site visit and answer questions from auditor and monitor.

9.Formulates guiding principles and Standard Operating Procedures (SOPs), and prepares staff for clinical research. Research and recommend processes and workflows for managing requests for materials.

• Research and write standard operating procedures (SOP) for clinics and clinical trials.
• Assist researchers to research and develop clinical research strategies and long term plans.
• Review industry best practices, procedures and policies associated with clinical trials and recommend areas for improvement.
• Research and draft regulatory documentation for review and approval by designated staff.

10.Reviews, assesses and evaluates clinical trial design and feasibility.

• Review clinical trial requests and opportunities, assess for feasibility and select studies.
• Develop clinical trial protocols, including objectives, design, methodology, statistical considerations and organization of the study.
• Develop and recommend changes to clinical trial protocols to improve the overall effectiveness of the study.
• Implement and monitor clinical trials, collecting data and preparing project updates, status reports and summaries of results.
• Develop project schedules, quality assurance plans and budgets in accordance with stakeholder expectations.

11.Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation.

• Review and recommend for approval requests and proposals from external institutions for collaborations and use of materials.
• Identify and monitor clinical trial risks and develop contingency plans and solutions.
• Provide recommendations to program management staff on clinical trial project schedules, resource, budgets and tracking.
• Develop frequently asked questions and other informational and guidance documents.
• Provide project management advice and recommendations to clinical trials, including scheduling, resource and budget management and reporting.