Description
Position summary:The Clinical Research Associate will be responsible for the monitoring and other tasks associated with clinical studies. The Clinical Research Associate will also be responsible for investigational site management for clinical studies and will assist in the implementation of protocols, informed consents, case report forms, clinical study reports and related study materials.
Essential Job Functions:
-
Monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols -
Actively participate in clinical trial activities from study planning through closure -
In conjunction with the Project Manager work with the CRO and assist in site selection process -
Order and coordinate study supplies at Investigator sites -
Assist in maintaining tracking tools -
Assist in site budget negotiations if needed -
Assist and support data validation and data clean procedures -
Assure regulatory compliance of investigational sites with SOPs and FDA and ICH guidelines -
Assist the Project Manager (if needed) with vendor management, including the Clinical Research Organization ( CRO ) in monitoring and data management, Drug distribution, Safety and other study vendors. -
Assist in planning and participate in investigator meetings -
Essential Trial Monitor activities for the largest study of its kind -
Develop Strategy and actively participate in creative investigator and patient recruitment programs -
Assist in guiding the progress of a landmark safety, effectiveness and outcomes trial
Job Qualifications:
-
3+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in monitoring of sites and in-house study management. -
Experience in protocol writing and informed consent development preferred. -
Experience in study site selection, site budget development / negotiations and overall site management preferred. -
Experience in vendor management (CRO, central laboratory, IVRS, EDC).
Education:
BA or BS required, preferably in one of the Life Sciences