CLINICAL RESEARCH ASSOCIATE 3

The ideal candidate will have thorough knowledge of Clinical investigation of medical devices for human subjects Good Clinical Practice (ISO 14155) 21 CFR partand other applicable regulations.
Roles & Responsibilities:
Contribute to all clinical research activities to ensure successful management of clinical studies under the direct supervision of Clinical Affairs manager with dotted lines to clinical study manager.
Maintain and track clinical study data and support in investigator qualification and selection analysis of potential patient recruitment and overall study status/progress throughout the life of a study.
Manage site startup/activation process including:

o Heavy contribution to the preparation of study related documents (protocols case report forms (CRFs) or eCRFs draft informed consent forms (ICF) and complete checklists able to support in clinical trial agreements and budget negotiation clinical monitoring plan)
o Organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.
Amends clinical study documents (ICF CRFs Monitoring Plan etc ) as needed and support clinical sites with institutional review board submission as necessary.
Perform onsite and remote site qualification visits site initiation visits interim monitoring visits and site close out visits
Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan.
Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy.
Serve as main liaison to participating clinical trial sites with focus on data entry query resolution investigational device tracking and accountability and study conduct oversight at the participating clinical sites.
Collaborate with data management to support data cleaning process
Lead review of safety events and collaborate on development of narrative and reporting as needed
Develop and manage study trial master file and maintain study documentation and clinical trial management system (e.g. correspondence CRFs study approval documents) trip reports site contact documentation monthly status reports (e.g. enrollment adverse events budget etc.)
Track process and manage site payments and support in study financial tracking by developing tracking tools as necessary.
Assist Clinical Study Manager on study scoping activities including but not limited to development of prestudy questionnaires study design and surgeon/site selection
Support site audits and site audit preparation in anticipation of site inspections.