Clinical Research Associate
PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Clinical Research Associate is to monitor clinical studies for Therapeutics, Inc. to ensure the studies are conducted in compliance with current applicable federal, state, local and corporate regulations and procedures [including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH)]. A secondary objective is to ensure clinical study schedules and budgets are met. This position will require 60-80% travel.
MAJOR RESPONSIBILITIES AND DUTIES:
The Clinical Research Associate must manage clinical study sites to ensure subject safety and compliance with the study protocol, timeline and budget, in support of on time and within budget regulatory submission.
Routine responsibilities will include:
- Assessment of the suitability of clinical sites to conduct specific studies
- Initiation of selected clinical study sites by providing training related to the protocol and management of the study
- Performance of routine monitoring of clinical study sites to ensure subject safety and protocol compliance
- Verification of data entered on the CRFs is consistent with clinical notes and other source documents
- Collection of completed CRFs and queries from clinical sites
- Writing monitoring visit reports
- Ensure the accountability of all test articles
- Close-out of clinical sites on completion of the study
- Assist with study file audits and site audit preparation
- Develop and maintain routine contact with clinical study investigators and staff
- Assist with protocol, case report form and source document template development
- Ensure compliance with appropriate regulatory (GCP, FDA, ICH, HBP, etc.) and internal guidelines
- Assist with final report preparation
- Assist with internal SOP/guideline development
The ideal candidate will have a Bachelor’s degree in a science-related background and sat least 2 years' experience in clinical research monitoring or a combination of education and experience that indicates the ability to perform the tasks associated with the Clinical Research Associate position. A knowledge/understanding of the principles of clinical research and drug development is desired but not essential. Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.