Senior Clinical Research Associate - FS to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You’ll Be Doing:
- Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records.
- Issues, investigates, and resolves any data discrepancies identified during source verification activities.
- Maintains thorough documentation and proper escalation of issues related to visit reports.
- Ensures any identified non-compliance issues are addressed.
- Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
- Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
- Performs budget negotiations with clinical trial sites.
What We Are Searching For:
- Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience.
- 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions.
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities.
- Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
- Willingness to travel up to 70-85%
Experience with Schedule 1 required.
