Job Description

Job Description

Job Description

Description

Responsible for oversight of assigned clinical research projects to ensure high quality data is obtained to support regulatory and marketing needs. This position takes a support or lead role in site initiation and interim monitoring, periodic reporting of study results, and other related activities. The documentation maintained by this position is critical in supporting successful inspections/audits of Exactech’s clinical studies.

• Monitor the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and all applicable regulatory requirements
• Conduct visits to assess the qualification of potential investigative sites, initiate sites, instruct site personnel on the proper conduct of studies and use of Electronic Data Capture (EDC) system, review and ensure accuracy of data collected, and terminate studies
• Monitor data submitted to the EDC system, perform source document verification, retrieve and/or ensure appropriate electronic submission of Case Report Forms (CRFs), and perform query resolution in a timely manner
• Ensure sites report adverse events according to protocol specifications
• Assist investigative sites with obtaining and maintaining Institutional Review Board (IRB)/Ethical Committee (EC) approval
• Work closely with other team members to ensure timely resolution of issues and obtain direction from project and department management
• Reconcile investigative site and sponsor files; request any new or updated site-related essential and non-essential documents and review them for content, consistency with other documents, and compliance with appropriate regulatory requirements, GCP guidelines, the study protocol, and applicable SOPs
• Assist other staff with developing and maintaining trial master files (electronic and hardcopy)
• Oversee device accountability (if required by protocol)
• Provide regular updates to project management
• Provide input to clinical data staff regarding CRFs and EDC forms
• May assist clinical data staff with creation of Case Report Forms and processing of incoming clinical data
• Knowing and applying the Quality System and appropriate federal and international standards
• Supporting other employees, teams, and sales personnel as necessary
• Practicing Exactech Values

Education:

• High School Diploma or GED required. Associate and/or Bachelor’s Degree from an accredited institution preferred 

Experience:

• Minimum 1 year clinical research experience required
• Understanding of clinical research and Good Clinical Practice (GCP) required
• Experience in regulated medical (device/pharma) industry preferred
• Orthopaedic background preferred 

Functional/Technical Knowledge, Skills and Abilities Required:  

• Must be detail oriented
• Excellent organizational skills
• Strong interpersonal skills; must build lasting relationships with co-workers, investigators, and investigator staff members
• Working knowledge of MS Office (Word, Excel, PowerPoint, etc.)
• Experience with electronic data capture (EDC) technology a plus
• Ability to learn new software programs
• Certification (CCRA, CCRP) preferred 

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