Description
Summary:The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practises (GCPs), SOPs, and study protocols.
Primary Duties:
- Review regulatory documents as required and prepare site visit reports.
- Responsible for multiple projects and must work both independently and in a team environment.
- May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organising and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
- May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed.
Requirements:
Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients.
- Prefer BS/BA- 2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation.
- Sound knowledge of medical terminology and clinical monitoring process.
- In depth therapeutic and protocol knowledge as provided in company training.
- Ability to perform travel an average of 65%, depending on project needs.
- Excellent verbal and written communications skills.
- In depth therapeutic and protocol knowledge as provided in company training.
- Excellent interpersonal and organisational skills and attention to detail.
- Computer literacy, proficiency in MS Office.
This is an excellent opportunity to work for a fast moving organisation. If this is of interest to you or anyone you know, and you would like some more information, please send an updated CV.