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Clinical Research Coordinator / SRA III

80Twenty, SAN FRANCISCO california

This job is no longer available.

Our client is a leading research and medical institute, with a beautiful office near the beach in San Francisco. They are now looking to bring on Clinical Research Coordinator who has run clinical trials to help with various projects and provide compliance oversight.


Requirements

• Implement the overall direction of clinical research projects as directed by Principal Investigator

and/or Manager of Compliance and Contracts

• Coordinate all aspects of the research protocol & manage the daily study operations, managing

research budgets, maintain essential research study documentation

• Maintain all regulatory approvals including IRB applications including renewals, amendments, and closeout

• Prepare study materials including, but are not limited to, the informed consent document, case report

forms (CRFs), enrollment logs, and drug/device accountability logs per FDA guidelines

• Establish and organizes study files, including but not limited to, regulatory binders, study-specific

source documentation and other materials.

• Oversee systems for tracking, collecting, and monitoring study progress to ensure adherence to

protocol timelines and standard operating procedures

• Ensures adherence to the enrollment goals of the study; maintains study enrollment timelines

• Work with the PI to manage the day to day activities of the study including problem-solving,

communication and protocol management

• Responsible for providing and documenting Informed Consent

• Schedule all assessment study visits and study procedures;

• Make necessary arrangements as required to evaluate the subject per study protocol

• Participate in subject recruitment efforts


Qualifications

• Requires a B.S. degree in a scientific discipline, and two to six years of minimum experience with direct

research administration

• Minimum of 2 years of industry experience, with direct clinical trial management

• MA/MS degree in scientific or related fields strongly preferred

• Has a thorough understanding of IRB, protocols policies and practices for conducting clinical

investigations

• Computer literacy with an emphasis on Windows operating systems and software applications

• Excellent interpersonal, written/oral communication and organizational skills

• Ability to manage multiple projects, tasks, and priorities to achieve desired goals

• Strong accuracy and attention to detail

• Excellent organizational skills

• Clinical Research Coordinator certification preferred

• Ability to work under minimal supervision

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