Title: Clinical Research Associate
Duration: 12 Month
Location: Whippany, NJ (at least 2-3 days a week)
Hours expected: 40 hours per week
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Description: accountable and responsible for all aspects of site management and monitoring activities for assigned Clinical Sciences Phase I and Phase IIa clinical investigator sites and phase I units. This requires an in-depth knowledge of the drug development process including monitoring and site management, local and international regulations and international regulations, ICH - GCP, drug safety requirements, data management processes and investigator grant parameters. The position also requires awareness and understanding of cultural differences as well as regional operational differences. Effective written and verbal English language communication skills, strong oral presentation, interpersonal, decision-making and issue resolution skills are required. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.
Travel Requirements: * Willingness and ability to travel frequently. Office-based in Whippany (at least 2-3 days per week)
Day to Day Duties/Responsibilities/ Scope of Work
- Perform On-site monitoring for selected phase I/II studies in USA (Site Selection visit including slide preparation, Site Initiation visit including training slides, routine monitoring visit, close out visit) * Preparation of Investigator Site file including preparation of site specific forms (e.g. Source Data Identification checklist) * Development or review of Study Monitoring Plan and other Monitoring documents as applicable (e.g. Drug accountability forms) * Join eCRF development and perform CRA role testing, e.g. perform Screen review and UAT (User acceptance test) * Escalates operational issues or potential issues to Study Manager as applicable.
- Bachelor's Degree; manager would consider candidates without degree with very strong work experience * 4-6 years of relevant healthcare experience of which 2+ years' experience of ongoing and current monitoring & site management experience preferably in early clinical development patient and healthy volunteer trials. * eCRF experience, preferably RAVE system
Preferences: * Any Latin American language communication skills
Sthree US is acting as an Employment Business in relation to this vacancy.