Clinical Trials Associate I
Summary of Position:
• Supports Clinical Lead in all aspects of study management; from study start-up to close-out activities.
• Maintains multiple study-related trackers for the management of study logistics, screening and enrollment objectives, and clinical supply; distribution and inventory.
• Assembles and distributes regulatory binders and study materials to clinical sites throughout studies.
• Assists in study file review and reconciliation for audits.
• Provides daily support to Access clinical team and clinical sites.
Access Biologicals is an innovative Life Sciences company with a growing biological specimen collections department. Candidates in this position will work closely with the Access team to ensuring that biologic specimen collections are conducted in adherence to study protocols, FDA regulations, and ICH/GCP guidelines. Candidate will assist with physician sites and vendors to help ensure that high quality clinical samples (serum, plasma, whole blood) are being provided to our customers for diagnostic research. We are looking for someone who is creative, resourceful and flexible to add to our growing clinical team.
• Maintenance of all study tools in excel
• Interaction with sales team and at time customers as representative of clinical research department
• Interface with upper management
• Communicate with clinical sites
• Start-up Visits for clinical collections
• Creation of PO within Access
• Vendor interaction
• Assistance with departmental tools and templates as needed
• Maintenance of department supplies and ordering
• Creation of study collection kits and shipping of study supplies to sites
• Regulatory binder creation
• IRB submissions as needed
• 20% travel for monitoring site visits
Experience should include BS or greater of science and 1-2 years job experience in clinical research related position. Experience with excel and Word a must. Excellent phone and written communication skills. Organization needed for this position and the ability to multitask.
Human Biologicals company operating in North San Diego County.
Sat, 12 Aug 2017 13:00:37 PDT