2023-03-13T00:00:00Z

Child Study Center - Integrated Program

80177BR

University Job Title

Research Support Analyst, CSC

Bargaining Unit

None - Not included in the union (Yale Union Group)

Compensation Grade

Administration & Operations

Compensation Grade Profile

Manager; Program Leader (24)

Wage Ranges

Click here to see our Wage Ranges

Work Location

Medical School Campus

Worksite Address

333 Cedar Street New Haven, CT 06510

Work Week

Standard (M-F equal number of hours per day)

Searchable Job Family

Research Res Support, Research/Support

Total # of hours to be worked:

37.5

Position Focus:

The Bloch Lab conducts clinical psychopharmacology research in depression, Tourette syndrome, OCD, anxiety and ADHD in both children and adults. This position is for a lab coordinator whose primary responsibility with be to coordinate a large, NIH-funded trial examining ketamine as a treatment for adolescents with treatment-resistant depression at risk for suicide. The coordinator will also help oversee industry-funded and investigator-initiated trials in pediatric psychopharmacology.

Essential Duties

1. Works directly and in collaboration with leadership, Departmental leaders, investigators, and research staff to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions.  2. Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice.  3. Identifies research non-compliance and reports to appropriate leadership 4. Provides educational and corrective action advice to faculty in preparation for FDA audits. Serves as liaison between the investigator, the research team and the FDA during an actual inspection. Records proceedings and summarizes inspection activity in real time.  5. Consults to investigators needing data safety monitoring plan details/information for their grant application. Develops Data and Safety Monitoring Plans based on the risk assignment categories. 6. Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance. 7. Analyzes protocol to customize audit plans for protocol specific benchmarks in addition to standard audit reviews.  8. Assesses audit findings in the context of the larger program to identify trends or program wide areas of in need of improvement or education. 9. Assesses the risk and stratify the study from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge. 10. Reviews medical records of study participants, determines the impact of non-compliance (e.g. violations of federal regulations, GCP and University policies) on study plans/processes, makes judgments and communicates findings to investigators.  Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities. 11. Reports QA findings related to deviations, non-compliance based on strict reporting regulations.   12. Reviews reports/findings from audits with investigators and advises and monitors appropriate action plan. 13. Conducts follow-up reviews for compliance with audit recommendations, responding to investigator rationale. Identifies trends in findings to be addressed in educational or corrective actions for specific group of researchers.  14. Designs and conducts training programs, makes recommendations for quality improvement, and assists in the creation and follow up of corrective action plans based on audit findings.  15. Develops and delivers education and training programs to promote safety and compliance for the PI's and all study team members. 16. Conducts continuous auditing activities identifying areas of high risk and creates activity reports for ongoing analysis from a medical standpoint.  Interviews individuals with specialized knowledge related to an investigation. Identifies areas of concern or heightened medical risk to subjects, investigators, or the University.   17. Integration of Data Safety and Monitoring Plans and QA findings with committees and educational plans.

Required Education and Experience

1. Bachelor Degree in related field and five years of related experience or an equivalent combination of education and experience.  2. GCP training required within 3 months of hire.

Required Skill/Ability 1:

Oversee and coordinate clinical trials and scientific research involving human subjects within well defined protocols. This will involve supervising and coordinating several postgraduate and postdoctoral associates in the lab as well as Associate Research Scientists and prescribers (MD and APRNs).

Required Skill/Ability 2:

Serve as initial source of correspondence and screening for families of children interested in clinical trials or oversee lab personnel involved in this process.

Required Skill/Ability 3:

Ensure compliance with University, Federal, and State guidelines, rules, and regulation. Including IRB and FDA submissions.

Required Skill/Ability 4:

Process and monitor expenses and ensure adherence to budgetary guidelines in association with business office personnel.

Required Skill/Ability 5:

Interface with sponsors (NIH and industry) to update on status of projects and recruitment efforts.

Preferred Education, Experience and Skills:

Masters or Graduate degree in psychology, social work or clinical research. Experience coordinating trials involving children and psychopharmacology. Experience interacting with families and children with mental illness (depression, anxiety, Tourette syndrome, etc.) preferred. Ability to process laboratory specimens and/or conduct basic clinical ratings with subjects is a plus.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

COVID-19 Vaccine Requirement

Thank you for your interest in employment at Yale University. Please also note that the university has a COVID-19 vaccination and booster requirement for all students, staff & faculty which is described in the COVID-19 Vaccine Program. As you search our open positions, you will see that all postings list their on-site addresses which gives more detail on the on-campus work location of the role.

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.

EEO Statement:

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

W.L. Harkness Hall, 3rd Floor, Room 303

100 Wall Street, New Haven CT 06511

203-432-0849

equity@yale.edu

Note

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