Garden Grove, California

Senior Clinical Research Coordinator

 

JOB DEFINITION:

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 followed.

Serves as the principal administrative liaison for assigned clinical trials.

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 studies.

Collaborates in the study selection process.  Delivers and facilitates professional presentations on research activities and evaluation results to PI and medical staff participating in research activities.

 

ESSENSTIAL DUTIES

Daily           

Manages assigned research study coordinators activities, provides oversight and assigns ancillary support staff to specific protocol activities in accordance with pre-established work scope.

Conducts management activities in a professional and educational manner.

Pre-Study and Pipeline

Determine feasibility of facility to conduct the study in accordance to protocol requirements

Oversee the coordination of departments for protocol execution.

Collect clinic demographics and complete site questionnaires for pipeline studies.

 

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 studies.

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.

 

Study Execution

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 law.

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 improvement

Confer with principal investigator(s) to assist in developing plans for research projects and to discuss the interpretation of results

 

Requirements

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 Coordinators

Some limited travel to Long Beach or Torrance may be required



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Garden Grove, California

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