Clinical Research Program Lead

Minimum Education
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
2-4 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.

Communication
 

• 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.

Project Management
 

• 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.

Professional Development
 

• 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.
• 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