Senior Clinical Research Coordinator
The Senior Study Coordinator is responsible for coordinating a
team of specialized research coordinators supporting clinical
research conducted by principal investigator(s).
The Senior Study Coordinator will also be responsible for
coordinating and participating in clinical research studies
conducted by principal investigator(s) in a variety of complex
activities involved in the collection, compilation, documentation
and analysis of clinical research data under the direct supervision
of the Principal Investigator.
Assists in project assignment and ensures that pre-established
work scope, study protocol, state and federal regulatory
requirements and Policies and Procedures are observed and
Serves as the principal administrative liaison for assigned
Ensures adherence to guidelines for the collection of clinical
data and/or administration of clinical studies.
Coordinates with the organization for the implementation and
execution of research projects such as pre-study activities,
initiation, execution, reporting on the status of various research
tasks and identifying ways to improve research conduct of
Collaborates in the study selection process. Delivers and
facilitates professional presentations on research activities and
evaluation results to PI and medical staff participating in
Manages assigned research study coordinators activities,
provides oversight and assigns ancillary support staff to specific
protocol activities in accordance with pre-established work
Conducts management activities in a professional and educational
Pre-Study and Pipeline
Determine feasibility of facility to conduct the study in
accordance to protocol requirements
Oversee the coordination of departments for protocol
Collect clinic demographics and complete site questionnaires for
Post Site Selection Activity
Develop recruitment strategies and formalize recruitment plans
collaboratively with study team and investigator(s)
Assigns study coordinator to research study based on workload,
study protocol complexity, and skills set
Assigns ancillary personnel involved in assisting study
coordinators in the implementation and evaluation of clinical
Facilitates staff in required training and education programs
for each protocol.
Oversees and ensures the training of new personnel.
Directs and approves the development of source, forms,
questionnaires and the application of research techniques.
Maintains current knowledge of journals, abstracts and
scientific literature to keep abreast of new developments and to
obtain information regarding previous studies to aid in the
planning of new studies.
Monitors active screening activities or each study and
facilitates the development and execution of enrollment plans.
Identifies and maintains compliance with all federal, state, and
professional regulatory standards as issued through OSHA, FDA, and
ICH for each study.
Ensures compliance with protocol guidelines and requirements of
regulatory agencies including HIPAA regulations and applicable
Monitor study conduct problems and/or inconsistencies; provide
corrective action as appropriate.
Facilitate accurate and timely data collection, documentation,
entry and reporting for all assigned studies.
Coordinate all monitoring and auditing activities
Evaluate and interpret study progress, trends and provide
appropriate recommendations or conclusions for study conduct
Confer with principal investigator(s) to assist in developing
plans for research projects and to discuss the interpretation of
5-7 years’ experience in clinical trial research at a CRO,
pharmaceutical/biotech or trial site
Previous management experience, this role will manage 5 Study
Some limited travel to Long Beach or Torrance may be
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applicants to meet accommodation needs that are made known to Kelly