Clinical Research Program Lead
2 weeks ago
B.A. BA/BS degree in science, technical, or health-related field with > 5 year relevant experience MS degree with 3 years relevant experience; Doctoral degree with > 2 years of relevant experience .
Minimum Work Experience
2 years 2-4 years of clinical research experience or an equivalent combination of relevant education and/or experience managing NIH or industry sponsored clinical research projects. Supervisory/management experience in related job function. Preferred/Desired Experience: Pediatrics experience preferred. .
Functional Accountabilities
Responsible Conduct of Research
- Consistently demonstrate adherence with the standards for the responsible conduct of research.
- Maintain confidentiality of data as required.
- Plan, conduct, and manage research and/or research intervention projects within the federal and institutional regulations and policies under the direction of the principal investigator.
- Responsible for appropriate use of research funds and resources.
- Comply with all annual job-related training requirements.
- Protect patient/family right to confidentiality in relation to research protocol.
- Act as a role model for other professionals by communicating responsively, respectfully, and assertively.
- Collaborate with physician and other health care professionals throughout all phases of the research process.
- Effectively manage day-to-day research and/or research intervention program operations.
- Ensure that sponsor/data center deadlines are met.
- Ensure timely IRB submissions and adheres to all reporting requirements.
- Clearly and concisely documents patient assessments, observations, test results, and other study related information per federal regulations/ICH guidelines, GCPs, SOPs, sponsor/CRO and IRB requirements.
- Oversee subject recruitment and study enrollment goals. Determines effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Manage resources within study budget, works with senior staff and principal investigators, identifies standard of care versus study procedures. Tracks patient and study specific milestones.
- Oversee data management for research projects. Develops and manages systems to organize, collect, report, and monitor data collection.
- Assist upper management in the development, implementation, and evaluation of services, programs, policies and procedures, and performance standards to achieve research team goals.
- Design, establish, and maintain an organizational structure and staffing to effectively accomplish the organization's goals and objectives; may assist with the recruitment, training, supervision, and evaluation of staff.
- Incorporate budget considerations in all planning and decision making.
- Assist the PI with the submission of progress reports, data updates and grant applications.
- Review journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information relevant to clinical research programs.
- Attend and contribute to team meetings, including working to set and achieve project timelines and deliverables.
- Represent the organizations at regional and national meetings.
Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
- Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
- Demonstrate collaborative and respectful behavior
- Partner with all team members to achieve goals
- Receptive to others’ ideas and opinions
Performance Improvement/Problem-solving
- Contribute to a positive work environment
- Demonstrate flexibility and willingness to change
- Identify opportunities to improve clinical and administrative processes
- Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
- Use resources efficiently
- Search for less costly ways of doing things
Safety
- Speak up when team members appear to exhibit unsafe behavior or performance
- Continuously validate and verify information needed for decision making or documentation
- Stop in the face of uncertainty and takes time to resolve the situation
- Demonstrate accurate, clear and timely verbal and written communication
- Actively promote safety for patients, families, visitors and co-workers
- Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
CN Hospital (Main Campus) (L002)
111 Michigan Avenue
Washington, 20010
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