*YCCI Clinical Research Associate (Monitor)
Company: Yale University
Location: New Haven
Posted on: May 12, 2022
Job Title: YCCI Clinical Research Associate (Monitor)Location:2
Church Street South Doctor's Building, New Haven, CT
06519Compensation Range: $66,000 - $85,500Type: Full TimePosition
- Reporting to the Assistant Director of Quality Assurance (QA)
and Monitoring for YCCI, the incumbent conducts clinical research
monitoring for clinical trials conducted at the Yale School of
Medicine and external (non-Yale) sites.The Clinical Research
Associate will be responsible for independently tracking, planning,
ensuring the research activities are conducted in accordance with
approved protocols and reporting monitoring activities. The
monitoring activities performed include but are not limited to:
Site Qualification Visits, Site Initiation Visits, Interim
Monitoring Visits, Close Out Visits per protocol specific
monitoring plans.The mission of the Office of QA & Monitoring
within YCCI is to foster a supportive environment conducive to
achieving Yale's clinical research mission and provide a central
resource to aid investigators, research groups and leadership with
respect to trial development, execution, and oversight. Frequent
travel, beyond CT, is required. This position will be partially
funded by the sponsored awards it supportsPrincipal Duties &
- 1. Works directly and in collaboration with YCCI leadership,
Departmental leaders, investigators, research staff, HRPP and the
IRB 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
- 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 within YCCI, Departmental leadership, HRPP,
the IRB and the OGC.
- 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
- 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
- 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 very 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
- 15. Develops and delivers education and training programs to
promote safety and compliance for the PI's and all study team
- 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
- 17. Integration of Data Safety and Monitoring Plans and QA
findings with committees and educational plans.Required
Qualifications & Skills:
- Bachelor Degree in related field and five years of related
experience or an equivalent combination of education and
experience. GCP training required within 3 months of hire.
- Professionalism, maturity, good judgment, and ability to work
with confidential material and protected health information.
- Self-directed with the ability to work, plan, research, and
conduct projects with minimal supervision and on a flexible
- Organized and capable of handling multiple/diverse projects
- Advanced interpersonal, oral and written communications skills
and ability to work effectively with a wide variety of external and
- Demonstrable understanding of clinical research processes and
procedures from study start-up to study close out.Preferred
Qualifications & Skills
- Master's Degree or other advanced degree in related field.
- SOCRA/ACRP (or equivalent) certification. -
Keywords: Yale University, New Haven , *YCCI Clinical Research Associate (Monitor), Healthcare , New Haven, Connecticut
Didn't find what you're looking for? Search again!