Clinical Research Associate

Exactech, Inc.
Job Description

Job Details

Description

The purpose of the Clinical Research Associate position is to be 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.

1. 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
2. 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
3. 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
4. Ensure sites report adverse events according to protocol specifications
5. Assist investigative sites with obtaining and maintaining Institutional Review Board (IRB)/Ethical Committee (EC) approval
6. Work closely with other team members to ensure timely resolution of issues and obtain direction from project and department management
7. 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
8. Assist other staff with developing and maintaining trial master files (electronic and hardcopy)
9. Oversee device accountability (if required by protocol)
10. Provide regular updates to project management
11. Provide input to clinical data staff regarding CRFs and EDC forms
12. May assist clinical data staff with creation of Case Report Forms and processing of incoming clinical data
13. Knowing and applying the Quality System and appropriate federal and international standards
14. Supporting other employees, teams, and sales personnel as necessary
15. Practicing Exactech Values

Job Requirements:

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

Qualifications
Education

Required

High School or better.

Preferred

Associates or better.
Bachelors or better.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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