Working collaboratively with the Lead CRA and Project Management, the CRA will assist in study start up activities including Site Evaluation and Site Initiation visits. Furthermore the CRA will, conduct on-site monitoring, and lead close-out activities at study sites as per the approved Monitoring Plan. This position works collaboratively 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 investigational site compliance to protocol, applicable SOPs, GCPs and Code of Federal Regulations (CFR) by assessing protocol, GCP, and regulatory compliance of investigational research sites.
Conduct site evaluation, initiation, interim and close-out monitoring visits as well as test article accountability and reconciliation.
Utilizes appropriate monitoring check-lists and report templates to record and report monitoring findings.
Documents monitoring activities in writing, using appropriate report formats and communicates such findings to the appropriate parties (clinical trials management, the principal investigator, and designated members of the regulatory and clinical trials staff) and maintains a record of all correspondence, monitoring reports and other written documentation in accordance with operating procedures.
Compares reported data with original source documents for 100% Source to CRF verification by reviewing the accuracy, completeness and timeliness of completed study related records, case report forms and other documents.
Reviews study related processes relative to applicable regulatory requirements, including the FDA’s GCP Regulations and departmental guidelines.
Conducts regular review for completeness and accuracy of trial material onsite from initiation through site closeout.
Verifies that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed.
Communicate with in-house project managers regarding site performance and issues and provides information and feedback to investigator, clinical project teams, and sponsors about study conduct, visit findings, and site performance.
Identify and follow trial execution issues to resolution and promptly communicates any serious deficiencies noted during monitoring to the appropriate parties.
Works collaborativelywith clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance.
Documents and follows to resolution actionable issues requiring corrective action.
Participates in meetings and in-service training activities.
Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors.
Promotes a work environment that stresses and demonstrates confidential practices.
Facilitates communication between the investigative site and the sponsor and its representatives. Performs 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.
Bachelor’s degree in applied or life science
Minimum of 2 years’ experience in clinical trials, preferably drug trial monitoring, or equivalent training and work experience.
Strong current/prior clinical trial study coordination experience considered.
Prior Ophthalmic experience preferred yet not mandatory