Manages the Clinical Research Services Office and staff and provides leadership in support of institutional, department and faculty goals related to the conduct of clinical research.
1. Manages and develops an effective staff: providing effective communication, leadership, guidance and resources. Determines staff qualifications and competency: recruits, interviews, selects, hires, trains, orients, mentors, evaluates, coaches, counsels, disciplines, and rewards. Establishes and monitors staff safety and regulatory compliance.
2. Serves as liaison between Principal Investigators and clinical research resources. Builds relationships with faculty and staff to enhance and grow the clinical research enterprise at NJH.
3. Assures the allocation, sharing and efficient utilization of clinical research resources while ensuring quality and consistency.
4. Assures compliance with all applicable regulatory requirements for FDA regulated clinical research.
5. Oversees uniform application of clinical research systems, policies and procedures across all clinical research areas.
6. Acts as a liaison among research managers, both clinical and administrative, to assure optimization of clinical research for the institution.
7. Establishes new business partnerships and maintains existing ones. Works with Investigators, sponsors, community members, and internal team members to optimize study processes and enrollment. Initiates and maintains contact with pharmaceutical companies regarding ongoing and future studies. Conducts prequalification visits with sponsor representatives ensuring that studies are conducted and coordinated well and in accordance with sponsor Standard Operating Procedures, FDA regulations and ICH/GCP Guidelines.
8. Directly oversees projects assigned to the research unit including start-up, implementation and close-out. Ensures prompt start-up, efficient and compliant implementation and orderly close-out.
9. Works with Manager of Clinical Research Finance & Systems in developing budgets that are fiscally sound and inclusive of all potential expenses. Interfaces with internal and external clinical resources to determine pricing. Ensures financial viability of Clinical Research Services program
10. Works with Research Regulatory Affairs to ensure timely IRB submission and regulatory compliance.
11. Develops programs to maximize subject recruitment at both the institutional and project level.
12. Creates, updates, and manages research unit policies and procedures demonstrating an in-depth understanding of FDA and IRB Regulations and ICH/GCP Guidelines. Institutes policies that are compliant with ICH/GCP regulations and guidelines, as well as institutional policies and procedures.
13. Assures adequate functioning of research unit equipment necessary for clinical research.
14. Serves as the unit representative to the FDA and assists FDA and Investigators during FDA audits. Manages the institutional FDA competency program.
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. Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
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. Business Acumen: Using economic, financial, market, and industry data to understand and improve business results; using one’s understanding of major business functions, industry trends, and own organization’s position to contribute to effective business strategies and tactics.
5. Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
6. Impact and Influence: Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations, and individuals involved. Taking advantage of opportunities to make a difference and have an impact. When used well, the intended outcome of this competency is the creation of goodwill, trust, and respect while motivating people to want to follow you even when they don’t have to.
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 Conflict: Dealing effectively with others in an antagonistic situation; using appropriate interpersonal styles and methods to reduce tension or conflict between two or more people. Addresses conflicts by focusing on the issues at hand to develop effective solutions when disputes or disagreements occur; helps others resolve conflicts by providing impartial mediation when needed.
9. Talent Management for Leaders: Clearly establishes and communicates expectations and accountabilities; monitors and evaluates performance; provides effective feedback and coaching; identifies development needs and helps employees address them to achieve optimal performance.
Supervisory or Managerial Responsibility:
Manages 10-20 employees.
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 in Biology, Chemistry, Behavioral Science, Science, Health, or Nursing required.
A minimum of seven (7) years of recent and related clinical research experience with at least two (2) years’ experience in FDA-regulated research and 2 years’ experience at the management level.
Special Training, Certification or Licensure:
Current Clinical Research Coordinator or Clinical Research Associate Certification preferred.