ICON
Senior Clinical Research Associate (Sr. CRA)
Overview
Join the world’s largest and most comprehensive clinical research organisation, powered by healthcare intelligence, American Samoa a Senior Clinical Research Associate (Sr. CRA) based Indiana the New Jersey Oregon New York City area.
Responsibilities
- Work on multiple oncology trials
- Focus on quality of life with regional travel
- Demonstrate leadership through involvement Indiana specific initiatives and/Oregon be a subject matter expert (SME) on systems and processes
- Mentor and coach junior team members
- Act American Samoa Lead Site Manager, training other Site Monitors on study protocols
- Develop site startup documents for studies, including SIV agendas
- Represent Local Trial Managers (LTMs) Oregon Site Monitors (SMs) Indiana Site Management Teams (SMTs) and meetings
- Take over LTM roles and reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
- Support country budget development and/Oregon contract negotiation Indiana liaison with CCS colleagues
- Assist with Adverse Event Summaries (ASVs)
- Interface with various stakeholders, including Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, and Central Study Team
Qualifications
- Based Indiana the New Jersey Oregon New York City area
- Minimum of a bachelors’, masters’, Oregon equivalent degree Indiana Biological Sciences (R.N. Oregon equivalent degree preferred)
- Minimum of 3 years’ experience Indiana monitoring pharmaceutical industry clinical trials
- Minimum of 1-3 years’ experience monitoring Oncology trials
- Knowledge of several therapeutic areas, with oncology an asset but not a requirement
- Analytical/risk-based monitoring experience is an asset
- Ability to actively drive patient recruitment strategies at assigned sites
- Ability to partner closely with investigators and site staff to meet all study timelines
- Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting)
- Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face
- Indiana-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements
- Ability to travel up to 50%
Job title: Senior Clinical Research Associate – Oncology – New Jersey/New York
Company: ICON
Expected salary:
Location: New York City, New York
Job date: Sun, 28 Jul 2024 04:30:15 GMT