Position Title: Clinical Research Associate
Reporting To: Director, Monitoring
Director Reports To: N/A
SUMMARY OF POSITION:
Working collaboratively with the Lead CRA and Project Management, the CRA will a ssist in study start up activities including Site Evaluation and Site Initiation visits. Furthermore the CRA will, conduct on-site monitoring, and lead clos e -out activities at study sites as per the approved Monitoring Plan. This po sition wor ks collaborative ly with cross-functional teams and independently to support the clinical trial activities. The CRA performs their duties in accordance with established procedures and in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization- Good Clinical Practice (ICH-GCP).
- Ensure inve stigational site compliance to protocol, applicable SOP s, GC Ps a nd Code of Federal Regulations (CFR) by a ssessing protocol, GCP, and regulatory compliance of inve stigational research sites.
- Conduct site evaluation, initiation, interim and clos e -out monitoring visits as well as test article a ccountability and reconcili ation.
- Utilizes appropriate monitoring check -lists and report templates to record and report monitoring findings.
- Documents monitoring activities in writing, using a ppropriate report formats and communicates such findings to the appropriate parties (clinical tria ls management, the principal investigator, and de signated members of the regula tory and clinic al trials staff) and m aintains a record of all correspondence, monitoring reports and other written documentation in acc ordance with operating procedure s.
- Compares reported data with original source documents for 100% Source to CRF verification by reviewing the accur acy, completene ss and timeliness of completed study related records, ca se report forms and other documents.
- Reviews study related proce sses relative to applic able regulatory requirements, including the FDA’s GCP Regulations and departmental guidelines.
- Conducts regular review for completene ss and acc uracy of trial material onsite from initiation through site closeout.
- Verifies that appropriate stor age, supply, us age, instruction, documentation and disposition are in place and followed.
- Communicate with in -house project managers rega rding site performance and issues and provides information and feedback to inve stigator, clinical project teams, and sponsors about study conduct, visit finding s, and site performance.
- Identify and follow trial execution issues to resolution and promptly communicates any serious de ficienc ies noted during monitoring to the approp riate partie s.
- Works collaboratively with clinical res e arch staff and inve stigators to address their concerns and to communicate findings that can lead to improved cl inical trial performance a nd/or compliance.
- Documents and follows to resolution actionable issues requiring corrective action.
- Participates in meetings and in -service training activities.
- M aintains in strict confidence all confidential information regarding clinical tr i als and clinic al research study sponsor s.
- Promotes a work environment that stress es and demonstr ates confidential practices.
- Facilitates communic ation between the inve stigative site and the sponsor and its representatives. Perfor ms related duties as required
REQUIRED SKILLS AND ATTRIBUTES:
- Understand how to properly assess an investigative site’s capabilities for conducting clinical research.
- Ability to monitor and report on the progress of the trial from start-up to completion. Knowledge of how to select and qualify an investigative site.
- Capacity to routinely assessing protocol and GCP compliance. Demonstrated ability to verify source data to reported data.
- Strong attention to detail in order to review completeness of the investigator site file. Knowledge to reconcile and return/destroy test article in the course of conducting initiation, interim, and close-out visits.
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol.
- Demonstrate an understanding of 21 CFR sections 11, 50, 54, 56, 312, 314 and 812 and familiarity with the Nuremburg Code, the Belmont Report, the Declaration of Helsinki (1989), and the ICH guidelines governing GCPs.
- A sound knowledge of ICH and Food and Drug Administration's Good Clinical Practices regulations.
- Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills.
- A comfortable familiarity with Excel, CTMS and EDC.
- Availability to travel up to 75% of the time.
- Associate or Bachelor's degree in applied or life sciences preferred; significant relevant experience may be considered in lieu of degree.
- Minimum of 2 years’ experience in clinic al trials, preferably drug trial monitoring, or equivalent tr aining and work experience.
- Strong current/prior clinical trial study coordination experience considered.
- Prior Ophthalmic experience preferred yet not mandatory