** We are looking for a Senior CRA who would be home based in any major metropolitan area close to an airport hub (preferably Northeast/East Coast region). Our home office is located in San Diego, Ca.
MAJOR RESPONSIBILITIES AND DUTIES:
The Senior 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 submissions.
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 of 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
Coordinate supplies forecasting and distribution
Communicate across departments and conduct project team meetings concerning status of the study and specific sites.
Mentor and training Clinical Research Associates on monitoring procedures and TI SOPs.
Must be willing to travel 60-80%
The ideal candidate will have a Bachelor’s degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent and at least 5 years experience in clinical research or the medical field or a combination of education and experience that indicates the ability to perform the tasks associated with the Senior Clinical Research Associate position. This candidate must possess a knowledge/understanding of the principles of clinical research and drug development. Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.