Performs high-level administrative and project management functions for grant funded clinical research study. Executes and manages study implementation at clinical centers for related research studies and clinical trials. Supports executive team for the program.
1. Serves as the liaison between upper-management and clinical centers to implement project. Coordination and scheduling of needs for study.
2. Performs functions of a clinical research coordinator: study visits/procedures, recruitment, tracking and scheduling of study participants as needed.
3. Initiates clinical centers for participation. Educates investigators, co-investigators, and research staff with program details. Heavy emphasis on training. Evaluate study institution performance.
4. Develops details for each assigned protocol, study, and/or project including initial interaction/negotiation, provide planning, development, operation, and reporting for each assignment.
5. Assures compliance with Good Clinical Practices, HIPAA regulations, IRB guidelines and NIH guidelines where necessary. Creates and maintains departmental standard operating procedures as necessary. Completes and maintains IRB documentation for assigned programs.
6. Ensures project documents are completed and stored appropriately. Creates and maintains databases, protocol documents and other files with relevant program information. Provides accurate data management, and reporting for clients, PI's, and managers, for ongoing projects. Develops project timelines for the purpose of visibility and completion according to contractual obligations. Potential to invoice clients and maintain financial records for assigned studies, or programs.
7. Works directly with clients and ancillary departments within NJH to ensure proper protocols are followed. Assures adherence to project quality control policies such as confirming the documenting of all quality control activities.
8. Participates in departmental strategic planning and outreach. Assists in research to identify new processes as they relate to specific projects.
9. Engages in study efforts to current and potential processes, generates leads and follow through on opportunities to proactively grow improve studies.
10. Demonstrates basic knowledge of appropriate scientific background for study including: human genetics, epidemiology, COPD disease characteristics and common complications and co-morbid conditions, smoking and addiction, lung mechanics and pulmonary function testing, medical physics of CT scanning, blood processing and DNA extraction.
1. Event planning for bi-annual meetings.
1. Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
2. Attention to Detail: Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
3. Building Strategic Relationships: Identifying opportunities and taking action to build strategic relationships between one’s area and other areas, teams, departments, units, or organizations to help achieve business goals.
4. Building Trust: Interacting with others in a way that gives them confidence in one’s intentions and those of the organization.
5. Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
6. Customer Focus: Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers’ and own organization’s needs.
7. Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
8. Managing Work and Time/Project Management: Effectively managing one’s time and resources to ensure that work is completed efficiently. Effectively manages project(s) by appropriately focusing attention on the critical few priorities; effectively creates and executes against project timelines based on priorities, resource availability, and other project requirements (i.e., budget); effectively evaluates planned approaches, determines feasibility, and makes adjustments when needed.
9. Problem Solving: Uses issue identification, data relation and comparison, pattern recognition and information gathering to create analyses and make recommendations.
Supervisory or Managerial Responsibility
Up to 20% overnight travel required
1. Be available to work as scheduled and report to work on time.
2. Be willing to accept supervision and work well with others.
3. Be well groomed, appropriately for your role and wear ID Badge visibly.
4. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
5. Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
6. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
7. Wears appropriate PPE as outlined by the infection control policies and procedures.
8. Demonstrates compliance with all state, federal and all other regulatory agency requirements.
Bachelor's degree required. Education in health, science, or technical field preferred. Master’s degree preferred.
A minimum of two (2) years of experience managing projects or programs. Pharmaceutical, bioscience and medical implant, or related industry experience preferred.
Special Training, Certification or Licensure
Project Management Professional (PMP) certification preferred.