Description
Key Features -Acts as the sponsor liaison to clinical sites for conducting clinical studies according to Good Clinical Practices (GCP), ICH Guidelines and the Code of Federal Regulations (CFR). Collaborates with Clinical Affairs team to effectively plan and execute clinical study program. Responsible for conducting site visits, such as site training, monitoring, and regulatory review of requirements in executing clinical studies to ensure proper data collection for submission of clinical study data to regulatory bodies. Performs role of a study coordinator for assisting investigators in conducting studies for the company's in-house clinical study program. Depending on level of experience with the operational and regulatory aspects of clinical studies may represent the Clinical Affairs department on cross functional project teams and train other CRAs.
Skills and Experience -
-Plans, conducts and monitors sponsored clinical studies.
-Prepares detailed reports surrounding study setup, study progress, and findings from monitoring/closeout visits.
-Assesses clinical investigators, study staff, and contract research organizations (if applicable) for compliance with study protocols, regulations, and Standard Operating Procedures. Implements appropriate corrective action as needed
-Assists in writing clinical study reports for inclusion in regulatory submissions and helps develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) with minimal assistance
-Effectively represents the Clinical Affairs department to support project teams, including assigned tasks by project manager.
-Interacts effectively with peers and leadership across departments and can interface professionally with outside investigators, IRBs, FDA, and companies
-Provides training to study staff and subjects at clinical sites
-Acts as a study coordinator for in-house studies
-Conducts interim and closeout monitoring visits as well as site initiation visits.
-Researches and collects information on regulatory/clinical requirements and standards.
-Works on multiple projects.
Education / Experience -
- Bachelor's degree, in a life science or health-related field
- Nursing or diabetes educator experience desirable
- 0-3 years CRA experience
- Experience working in the medical device industry preferred
- Involvement in regulated medical device studies, with a knowledge base of medical device regulations.
- Professional certification (e.g. ACRP, SoCRA) considered a plus