Neurology – Clinical Research
University Job Title: Coordinator 4, Research Support
Bargaining Unit: None - Not included in the union (Yale Union Group)
Time Type: Full time
Duration Type: Regular
Compensation Grade: Clinical and Research
Compensation Grade Profile: Supervisor; Senior Associate (23)
Medical School Campus
15 York Street
Standard (M-F equal number of hours per day)
Total # of hours to be worked: 37.5
Searchable Job Family
Clinical, Research Res Support, Research/Support
Reporting to the Principal Investigator of StrokeNET and the Clinical Research Manager-Neurocritical Care and Neurovascular, the StrokeNET Program Manager oversees research participant activities for a variety of StrokeNET studies at Yale. StrokeNet is a NIH funded stroke trials network in which Yale is a collaborative site with Brown University and Hartford Hospital to create SPIRIT (Southern New England Partnership In Stroke Research, Innovation and Treatment) https://nihstrokenet.org/. SPIRIT is one of only 25 nationally funded regional coordinating centers within StrokeNet in the country. StrokeNet was developed to promote and conduct high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment and recovery. It is designed to serve as an infrastructure and pipeline for exciting new potential treatments for patients with stroke and those at risk for stroke.
As the StrokeNET Program Manager the primary duties of this position include: study start up, oversight of recruitment and trial activities, collaborating with other satellite and clinical performing sites, planning meetings, scheduling calls and setting agendas for network related events, quarterly matrix and reporting, serve as liaison between StrokeNet program/Yale site/Affiliated Programs, quality control review of study activity, SOP development and implementation, and regulatory updates for all StrokeNET studies at Yale site. May include direct patient activities for certain studies as determined by staffing needs.
1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. 2. Documents established congruency between funding proposals and approved protocols. 3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. 4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. 5. Attends meetings and presents issues when necessary that were identified during congruency review. 6. Serves as a resource and provides technical assistance to investigators and their staff. 7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. 9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform other duties as assigned.
Required Education and Experience
Bachelor’s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.
Required Skill/Ability 1: Strong clinical and research skills, including a thorough knowledge of medical and research terminology, along with an ability to train and provide guidance to research assistants on clinical trials.
Required Skill/Ability 2: Flexibility and capability to work as a team player. Excellent interpersonal and communication skills, including ability to effectively present and work with a wide variety of stakeholders.
Required Skill/Ability 3: Proven problem-solving skills including an ability to independently prioritize tasks with competing deadlines and priorities.
Required Skill/Ability 4: Demonstrated skilled knowledge of Good Clinical Practice along with University clinical research guidelines. Proven ability interpreting federal, state, University and sponsor policies and regulations. Demonstrated ability with interpreting clinical trial protocols and federal, state, local guidelines.
Required Skill/Ability 5: Exemplary time and attendance, including being able to be flexible in schedule to attend to project needs and subject recruitment including a rotation for 24x7 on call schedule for the Stroke/Neuro Critical Care Research Units.
Preferred Education, Experience and Skills:
Master’s degree in health or research related discipline and two years of related work experience in a similar job family.
Preferred Skill 1: Familiarity with neurological clinical research strongly preferred, especially with a focus on inpatient research and/or stroke.
Preferred Skill 2: Experience in EPIC and OnCore systems and IRB submissions.
Preferred Licenses or Certifications:
Certified Clinical Research Professional (CCRP) or equivalent.
Weekend Hours Required?
Evening Hours Required?