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Clinical Quality Associate
Clinical Quality Associate
(All applicants please send resume in Word format to email address shown at the bottom of description)
Support the day-to-day quality assurance of the Clinical Trial operations. This encompasses all clinical trials within the company. Identifies and resolves problems as they arise.
This level is characterized by responsibilities of a junior to mid-level individual with the ability to interact with Project Managers and CRA’s. The individual requires minimal supervision and ongoing training in order to assure consistent performance.
Specific Duties
Will work directly with the Clinical Trials personnel in the implementation and QC of all policies and procedures to ensure the quality of all trial data, including tracking of trial data and maintenance of standard operating procedures.
Identify problem areas in the individual trials and work in conjunction with the Project Managers to resolve them.
Support the collection and review of all trial data for accuracy and oversee the resolution of all inaccuracies.
Support the streamlining all trial quality assurance functions thus improving quality and accuracy of all trial data by introducing new techniques, rules, and regulations as needed.
Support the timely collection and monitoring of data tracking and trial updates.
Support the timely completion of evaluations for direct reports.
As new trials are awarded, provides support for ensuring that all standard operating procedures for trial workflow conform to the proper regulatory standards in the following areas:
Technician training
Radiologist training
Collection of data
Handling of data
Storage and backup of data
Overall quality of final product upon delivery of sponsor
Other support duties as required to meet goals established in designated trials.
Reporting Relationships
Reports to the Director of Quality Assurance
Decision Making Authority
Supports the quality assurance workflow of all trial data. Supports routine operations of trials as necessary to ensure that standard operating procedures are followed. Acts as liaison between Management, Project Managers and Clinical Research Associates to meet regulatory standards. Recommends procedural or system changes to the Director of Quality Assurance to improve the effectiveness of the trials’ operations.
Relations With Others
Must demonstrate consistent and cooperative service in support of trial sponsors, staff, co-workers, and individuals outside of the organization. Must exhibit and maintain a team approach and a positive attitude. Must maintain the enforcement of current regulatory standards in all trials without alienating other co-workers.
Education and Experience Required
Bachelors (BS/BA) degree required.
Computer skills
Excellent communication skills
Excellent organization skills
Knowledge of FDA GCP
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| Additional Information |
Salary: $35000 to $45000 Per Year
Position Type:
Employee
Ref Code: 003 |
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