Clinical Research Associate (CRA) III Position Description
- Member of the global medical affairs evidence solutions medical research support team (clinical team) responsible for processing the intake, review, contracting, activation, conduct and closeout of Investigator Initiated Research and External Collaborative Research studies within Global Medical Affairs.
- Responsible for assisting Medical Research Supervisor and Evidence Leads in the preparation for scientific medical review of concept and protocol submissions. Provide oversight to approved studies, assuring timely enrollment of patients and retrieval of required document from investigators/study sites, processing workflow status within the study submission and study maintenance system, coordinate drug shipments, prepare payments, receive and route study publications and CSR, perform study closeout activities.
- Responsible for executing all elements of externally sponsored research in compliance with quality standards (ICH/GCP, Global Regulations, (e.g., drug supply management, ICBs, reviews and approves HCP invoices/ payments against executed contracts) with minimal oversight and guidance.
- Responsible for management of clinical essential documents and critical regulatory documents for assigned projects/studies to ensure document packets for study start-up are complete and accurate and consistent with the study start-up timeline.
- Routinely interact with Evidence Leads on assigned projects and in meetings.
- Supports the preparation of Scientific Review Meetings (Agenda/ Meeting Materials).
- Supports on audit/ inspection activities for GCP requirements.
- Responsible for regular updates appropriate for cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
- Participates in process improvement initiatives.
- At least 4-6 years pharma related research experience
- Bachelor's degree
- Knowledge of externally sponsored research (IIS, external research collaborations)
- Knowledge of clinical study execution
- Knowledge of Good Clinical Practices and ICH/Guidelines, and/or other Global Regulations
- Excellent organizational skills, attention to detail, and strong oral and written communications skills
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.