Phase I-IV research site in Pasadena, CA is seeking a site level clinical research associate.
The Clinical Research Associate conducts site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines and GCP.
Participates, conducts or assists with the following duties as consistent with training completed:
Assists with the implementation of Project Plans related to the Clinical Monitoring responsibilities
Participates in initial and on-going protocol and CRF training
May serve as the Primary contact for the clinical sites/Sponsor
Participates in the generation of study specific monitoring plans
May assist in the development of Case Report Forms
Participates in the development of and/or review of conventions for CRF transcription
May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Visits
Participates in Sponsor and Investigator/Initiation Meetings
Tracks progress of assigned studies projects and identifies appropriate actions to achieve target objectives
Fulfills on-site Monitoring Responsibilities
Ensures the resources of the Sponsor and Lotus are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Lotus travel policy.
Prepares accurate and timely monitoring visit reports.
Identifies and completes follow up of SAEs at study site for which he/she is responsible
Independently performs CRF review; query generation and resolution against established data review guidelines on Lotus or client data management systems.
Performs other related duties as assigned
Desired Skills and Experience
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
In lieu of the university /college degree or certification requirement, 3 or more years of relevant clinical research experience in health care, pharmaceutical or CRO settings may be considered
Valid Drivers License
Fluent English with excellent verbal and written communication skill
Must be legally authorized to work in the US
2 years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management).
Additional experience may be substituted for education requirements.
Proficient computer skills with good working knowledge of a range of standard computer software required (e.g. email, document, spreadsheet and presentation software)
Knowledge of the drug development process.
Thorough knowledge of ICH guidelines, GCP and the clinical trial process.
Study coordination, project coordination and/or project management experience in early phase clinical trials
Experience using electronic CRF platforms and processes.
6 months or more of field monitoring experience as CRA
Strong background in oncology as a study coordinator and/or research nurse
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