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Onsite Research Associate - Site Level

Expired Job

The Talent Professionals Los Angeles , CA 90001

Posted 4 months ago

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

Education/Qualifications

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

Experience

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)

Preferred:

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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Onsite Research Associate - Site Level

Expired Job

The Talent Professionals