Description :
Overview :
The Clinical Research Associate (CRA) is responsible for in-house and on-site monitoring and program management of phase I to phase IV clinical trials. This position assures adherence to Good Clinical Practices and the integrity of the clinical trial, including but not limited to data and investigator compliance with all study procedures related to on-site monitoring. He/she is responsible for regulatory reviews related to conducts of trials and study/patient tracking and adheres to standard operating procedures. This position may travel extensively to regional clinical study sites and corporate headquarter offices and may provide training and mentoring to junior CRA's.
Responsibilities :
Clinical Team Member functions:
Participate in study development and startup including protocol writing (provides first draft, reviews final protocols)
Design and/or review CRF's and source document, develop CRF completion specification
Make sure sites have all the supplies needed for clinical trials
Be the main contact for sites, besides the monitoring CRA
Develop monitoring forms and aids, manuals and site manuals
Organize and participate in investigator meetings
Coordinate monitoring activities
Conduct project specific CRA training, as requested
Attend clinical project team meetings
Track study progress and patient enrollment
Assist in the development of SOP's
Assist in other clinic team activities as directed by supervisorStudy monitoring duties:
Serve as primary contact for study site personnel
Perform site selection/site initiation visits, on-going monitoring and study termination/close-out visits
Provide regulatory document reviews and expertise regarding clinical-regulatory requirements
Verify CRF submission forms, review CRF data for completeness, accuracy and adherence to protocol
Maintain awareness of developments in the field of clinical research by reading relevant literature, attending clinical group meetings, etc.
Perform other tasks as assigned by supervisor
Qualifications :
Bachelor degree in a related, scientific field
Experience (2-4 years) working as a CRA with demonstrated knowledge in above listed responsibilities
Pharmaceutical or corporate experience is desired
Proficiency with MS applications and internet research
Must be willing to travel 25% - 75% to investigational sites
Able to work independently, with little or no supervision and exhibit initiative
Must have excellent communication skills and high attention to detail