Performs high-level administrative and project management functions for grant funded clinical research study. In conjunction with Supervisor, executes and manages study implementation at multiple clinical centers across the United States. Supports executive team for the program working independently with minimal oversight.
1. Leads clinical coordinators and can perform functions of a clinical research coordinator: study visits/procedures, recruitment, tracking and scheduling of study participants as needed. Trains staff at clinical centers: including the Clinical Center Directors, Clinicians, Radiologists, Coordinators and technicians.
2. Manages the COPDGene clinical center reimbursements.
3. Coordinates completion of each study visit, ensuring data quality and accuracy of the data prior to initiating payment to each clinical center.
4. Coordinates contracts and subcontracts for multiple clinical centers.
5. Meets recruitment goals that are implemented for COPDGene at each of the clinical centers. This involves weekly reports to COPDGene Executive Committee and to the NHLBI Project Officers.
6. Ensures data accuracy and transfer to analytical centers supporting the study.
7. Collects death documentation, death certificates, medical records, and informant interviews at all clinical centers in study. Review for compliance with study standards.
8. Serves as the primary contact between management and clinical centers to implement projects.
9. Coordination and scheduling of needs for study. Approves and recertifies clinical centers prior to participation in study through training and review. Responsible for on-going study monitoring and evaluation of clinical center performance.
10. Develops written training program for clinical coordinators at multiple clinical centers, implemented with on-sight training at National Jewish Health and at the individual clinical centers. This program is supplemented by regular webinars to maintain on-going conformity to all study standards.
11. Develops protocols and coordinates its approval by IRBs at all clinical centers. This includes informed consent and conformance to HIPAA requirements. May participate in providing information to regulatory agencies regarding study.
12. Generates reporting performance metrics for each of the clinical centers annually to the NHLBI.
13. Responsible for providing reports for study Observational Safety Monitoring Board.
14. Assures compliance with Good Clinical Practices, HIPAA regulations, IRB guidelines and NIH guidelines where necessary. Creates and maintains departmental standard operating procedures as necessary. Partnering with supervisor, completes and maintains IRB documentation for assigned programs.
15. Ensures project documents are completed and stored appropriately.
16. 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.
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. Initiative: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
9. 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.
10. Problem Solving: Uses issue identification, data relation and comparison, pattern recognition and information gathering to create analyses and make recommendations.
Supervisory or Managerial Responsibility
Leads the work of others
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.
Master’s degree required.
A minimum of 3 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.