The Clinical Trials Network (CTN) Manager will function in a complementary and collaborative fashion with institutional offices to facilitate the safe and ethical conduct of research involving human subjects. As such, s/he will have access via the ICTR directors to the leadership of the institutions who oversee all research. A primary focus will be to serve as a resource for investigator-initiated multi-site research using the new NIH clinical trials network (https://trialinnovationnetwork.org). By interfacing with the IRB and other aspects of the Human Research Protection Program, the CTN Manager is a resource to the investigators on regulatory issues, and will also liaise with experts in recruitment and retention, data and safety monitoring, implementation of Good Clinical Practice (GCP) and investigator/coordinator training, recruitment of study coordinators and trial teams. S/he works in accordance with the policies of the Albert Einstein College of Medicine and the Montefiore Medical Center on achievement of the goals and objectives of the institutions related to clinical research. This is a service position that will serve as a member of the Hub Liaison Team for the CTSA Trial Innovation Network (TIN).
- Lead the Liaison Team at Einstein/Montefiore CTSA hub for the national Trial Innovation Network (TIN). Communicate to investigators and stakeholders what the TIN has to offer in terms of services and consultation to investigators at the local level. Assist investigators and study teams in developing new projects, accessing TIN services, including participation in multi-site clinical trials, consultation for NIH grant submissions, use of recruitment tools, electronic health record (EHR) cohort assessments, etc.
- Organize and participate in monthly meetings of the TIN Hub Liaison Team, and work with the national network teams.
- Collaborate on developing Standard Operating Procedures for investigators to access central IRB resources, standard trial agreements, protocol submission processes, and other resources for participation in NIH and industry-sponsored clinical trials.
- In collaboration with the OCT and ICTR Informatics Core, ensure that researchers have access to innovative recruitment and retention tools.
- Assist investigators with regulatory support services in collaboration with the IRB and Compliance Officer.
- Facilitate communication between investigators, the IRB, the ICTR and the OCT.
- Participate in orientation and training programs for new investigators, study coordinators and research assistants around new clinical research management systems (Epic and Velos, for example), and dissemination of NIH and other policies related to clinical trials.
- Provide training opportunities that cover roles and responsibilities, policy requirements, and specific topics such as analyzing and implementing a research protocol and IND/IDE preparation and reporting.
- Advise on policy regarding research subject safety and data monitoring. Review protocols to evaluate the safety plans and facilitate the ethical conduct of research involving human subjects.
- Identify service improvement opportunities that will reduce or eliminate barriers to research as experienced or perceived by research participants.
- Represent the Institution at national CTSA initiatives and meetings that cover the above areas of responsibility and relate to CTSA-specific initiatives around these themes. Strengthen local, regional and national networks, and build collaborations around common goals.
- This is a managerial role with leadership potential. Candidates must be able to deliver results, and exhibit leadership qualities such as accountability, resourcefulness, and integrity.
- This position requires a high degree of flexibility and self-direction since the number, scope, and nature of research protocols are variable.
- S/he must be able to interact well with internal and external stakeholders who may have conflicting priorities and needs.
- This position requires a high degree of maturity and the ability to maintain confidentiality of sensitive information, such as compliance issues, medical information, and programmatic issues.
- Influences the behavior of others through effective communication. Excellent written and verbal communication is required.
- Seeks input, meets expectations and maintains communication with the client.
- Recognizes strategic opportunities to enhance success.
Bachelor’s degree required; Master’s degree preferred. Five (5) years of clinical research experience and skills beyond those of a study coordinator (i.e., ready to make the transition to a managerial role) required. Experience in the entire clinical trial process, as well as regulatory expertise is a plus. Experience at an academic center is preferred.