Assist in development and review of clinical protocols, case report forms (CRFs) and monitoring
plans for pre and post-market studies;
Manage the conduct of clinical studies, and the interaction with CROs and other outside
vendors;
Develop and procure study materials and distribute to sites;
Supervise collection of regulatory documents from clinical sites;
Assess adequacy of clinical sites for study participation;
Monitor clinical sites;
Conduct initiation, interim, close out and audit visits as required;
Support tracking of study related timelines and budgets;
Communicate with internal departments as needed, including attending program meetings and
following up on action items;
Plan, coordinate, prepare presentation materials and present information at Investigator
meetings;
Assist in development of departmental SOPs, personnel and training programs;
Review study data and resolution of queries;
Assist and review clinical study reports;
Other duties as deemed necessary by the Company. |