· Manage external vendors and contract research organisations.
· Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual.
· Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents.
· Assist with protocol development and study report completion.
· Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols.
· Provide guidance, direction, and management to CRAs.
· Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities.
· Coordinate study supplies.
· Negotiate contracts with vendors of clinical trial services.
· Review Informed Consent Forms, CRFs, and study related materials.
· Plan and participate in investigator meetings.
· Assist and support data query process.
· Assure regulatory compliance of investigational sites with sponsor’s SOPs and FDA and ICH guidelines.
· Ensures trial master file is current and maintained.
Please note that responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.