Clinical Research Program Lead

May 14, 2021
Jun 18, 2021
Analyst, Research
Full Time
The Clinical Research Program Lead (CRPL) is a senior clinical research professional responsible for the operational logistics and coordination of research and/or research intervention projects under the direction of the principal investigator (PI). The encumbered has advanced knowledge and understanding of the planning, implementation, and management of research operations. Responsible for planning and management of the approval, implementation and conduct of research protocols and/or research interventions from planning through completion and reporting, ensuring that the processes, integrity and quality of the research are assessed and maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, organizational Policy & Procedure, and research protocols. Serves as a resource for inquiries and maintains communication with the Investigators, participants, sponsors, IRBs, DSMBs and other research related entities. Functions as a departmental resource in research operations. Works independently and may mentor, train and direct the work of Clinical Research Coordinators/Assistants/Interns. Demonstrates expert clinical, organizational, and communication skills and functions as resource regarding the clinical research and/or grants process. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. Facilitates the preparation of Institutional Review Board applications for research proposals, develops and manages budgets and coordinates grant applications, progress reports and regulatory documentations submissions as required by the sponsor. The position will interface with faculty, collaborators, and administration to report project progress and trouble shoot barriers. Outstanding communication and organizational skills, the ability to proactively manage challenges, and strong attention to detail are required. The individual is supervised by a Clinical Research Program Manager/Director or the Principal Investigator.


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
1. Consistently demonstrate adherence with the standards for the responsible conduct of research.
2. Maintain confidentiality of data as required.
3. 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.
4. Responsible for appropriate use of research funds and resources.
5. Comply with all annual job-related training requirements.

1. Protect patient/family right to confidentiality in relation to research protocol.
2. Act as a role model for other professionals by communicating responsively, respectfully, and assertively.
3. Collaborate with physician and other health care professionals throughout all phases of the research process.

Project Management
1. Effectively manage day-to-day research and/or research intervention program operations.
2. Ensure that sponsor/data center deadlines are met.
3. Ensure timely IRB submissions and adheres to all reporting requirements.
4. 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.
5. Oversee subject recruitment and study enrollment goals. Determines effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
6. 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.
7. Oversee data management for research projects. Develops and manages systems to organize, collect, report, and monitor data collection.
8. Assist upper management in the development, implementation, and evaluation of services, programs, policies and procedures, and performance standards to achieve research team goals.
9. 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.
10. Incorporate budget considerations in all planning and decision making.
11. Assist the PI with the submission of progress reports, data updates and grant applications.

Professional Development
1. Review journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information relevant to clinical research programs.
2. Attend and contribute to team meetings, including working to set and achieve project timelines and deliverables.
3. Represent the organizations at regional and national meetings.

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
1. Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication 1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions
Performance Improvement/Problem-solving 1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

1. Use resources efficiently
2. Search for less costly ways of doing things


1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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