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Clinical trials are conducted by multifunction implementation teams consisting of investigators, study coordinators, clinical research associates (CRA), data managers, statisticians and safety officers involved in the setting up, running and reporting of clinical trials. Please choose a career that interests you for a detailed description.
Clinical Research Associates (CRA)
 CRA, also known as a Monitor, is a person employed by the drug or medical device development company or their designee who is responsible for determining that a trial is being conducted in accordance with the trial guidelines and requirements. A monitor’s duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial.
The CRA’s responsibilities include but are not limited to the following: Monitoring that the clinical study site personal follows the Good Clinical Practices and the study protocol; Verifying the filing and maintenance of the required regulatory documents and performing study drug accountability; Ensuring that any applicable side effects are properly documented and reported to appropriate regulatory bodies and trial sponsor
The CRA is usually employed by a pharmaceutical company, contract research organization (CRO), academic institution, or site management organization. A CRA can work either in-house or in the field, requiring 50-70% travel. A field monitor will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.
What are the typical yearly salaries of CRAs? (From www.salary.com, HR Reported data as of August 2007): CRA Level I (0-3 years experience): $42,000 to $68,000 CRA Level II (2-5 years experience): $55,000 to $87,000 CRA Level III (5+ yrs experience): $68,000 to $103,000 Clinical Research Manager: $82,000 to $123,000
Data Manager (Clinical Data Specialist)
 The clinical data manager is responsible for tracking and committing to database the data gathered from clinical trials of new drugs and medical devices. They must guarantee the completeness, accuracy and consistency of the data so that it meets the standards of quality expected for reporting to regulatory agencies.
A clinical data manger processes clinical trial data using a range of computer applications and database systems to support collection, cleaning and management of subject data. Typically this includes:
- contributing to the design of protocols, which define what and when data are to be collected;
- designing and approving forms on which data are collected;
- designing databases, ensuring they meet requirements for the entry and reporting of clinical data;
- training clinical research associates to help improve the quality of the data being collected;
- producing summaries and listings of safety and efficacy data;
- testing new processes and systems for the management of clinical trials.
What are the typical yearly salaries of Data managers? (From www.salary.com, HR Reported data as of August 2007): Typical employers would be pharmaceutical companies and clinical research organizations (CROs).
Clinical research coordinator (CRC)
Clinical research coordinator (CRC) is a person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse and protocol nurse.
This person is responsible for facilitating the conduct of research studies by coordinating the processes essential for accurate and timely data collection, assuring the recruitment of qualified study subjects, data collection and data management.
The CRC’s responsibilities include but are not limited to the following: Conducting clinical study according to the Good Clinical Practices and all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test, procedures, laboratory information, and drug accountability requirements; Completion of all study documentation forms, including case report forms and other study specific documents.
Filing and maintenance of the required regulatory documents and performing study drug accountability; Ensuring that any applicable side effects are properly documented and reported to appropriate regulatory bodies and trial sponsor Interact with Principal Investigator as needed to assure patient receives appropriate medical evaluation and care when needed, alerts Principal Investigator of serious adverse events. Interacts with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process.
A CRC may service either single or multiple medical offices where the study is conducted. It may require 5-10% travel (ex. to attend Investigator/Study Coordinator meetings as needed for assigned protocols).
What are the typical yearly salaries of CRCs? (From www.salary.com, HR Reported data as of August 2007): |
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