Description :
POSITION SUMMARY Reporting to the Clinical Study Manager, the incumbent is responsible for day to day administration of clinical trials. MAJOR DUTIES AND RESPONSIBLITIES Monitor activities at clinical study site including study initiation, interim monitoring and close out visits (up to 50% travel) Prepare clinical documentation (IFUs, training materials, data forms, study manuals) Establish and maintain strong relationships with Study Coordinators and PI's Assist with site training (GCPs, protocol, product implant) Routine communications with site re: status/resolution of study queries Maintain clinical file, ensure clinical file documents (e.g. AEs, annual IRB reports, normals, CVs are updated annually or more frequently as needed) Liaison with data management CRO, track status of data entry and data lock Ability to be present during surgical procedures, as needed. QUALIFICATIONS Work Experience: · Minimum three years as a clinical research monitor/associate in Class III medical device, drug or biologic trials · Background in clinical research and medical terminology · Familiarity with clinical research data entry Skills (Technical): · Strong initiative and ability to work with minimal supervision · Fluency in Windows and Microsoft Office (Word, Excel, Access Powerpoint) Skills (General Knowledge): · Verbal & Written Skills · Strong analytical ability · Quality - is attentive to detail and accuracy · Project Management Skills - ability to multi-task · Planning & Organizational Skills · Interpersonal Skills · Flexibility & Creativity · Communicates Openly Education · BS in a health or science-related field, nursing degree preferred but not required