Clinical Research Administrator
The clinical
research administrator, or CRA, is a paramedical who assists the
clinical research physician during the conduct of investigative
clinical trials.
Some of the
responsibilities of a CRA include:
- protocol
development (preparation of plan to conduct an investigative
clinical trial)
- initiation of clinical trials (identifying
qualified investigators, qualifying trial sites, submitting
appropriate documents to regulatory bodies, coordinating trial
with sponsors, etc..)
- monitoring and ordering of clinical trial
materials (human subject binders, regulatory binders, lab
supplies, etc.)
- administration of clinical trials (assisting
investigators / sites in regulatory document submission,
etc.)
- preparation and facilitation of clinical trial
trainings (investigator start-up meetings, teleconferences,
etc.)
- monitoring of clinical trials (reviewing
inclusion / exclusion criteria for human subjects, qualifying
study entry for human subjects, conducting site initiation /
interim / and close-out visits, etc.)
- data
validation transcribed by site to case report
forms
(verifying accuracy, matching source documents to case report
forms, etc. )
- monitoring site quality (coordinating
procedures and processes of a protocol in a timely, efficient
manner).
- preparation and submission of monitoring trip
reports, as well as expense reports and site reports,
etc.)
- development and maintenance of site
relationship during the conduct of the clinical trial
- monitoring of safety and
efficacy data (preparing appropriate reports for
regulatory and site submission, etc.)
- project
management of clinical trials
- coaching
and training of new employees
- conducting in-services to sites and employees
- preparation of case report forms
and
source
document worksheets
- budget
negotiation and grant preparation for investigators
- organization and preparation of new drug
applications
- initiation and preparation of letter of
confidentiality and letter of agreement to / from
investigator
As you can
see, a CRA is a very important and active participant on the study
team.
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