Job Description
Successful candidate will be involved in all aspects of clinical trial conduct, including but not limited to:
Preparing and distributing study materials such as case report forms (CRFs), study reference manuals, and monitoring guidelines/manuals
Participating in investigator meetings
Performing activities required to initiate clinical trials at investigative sites, including managing Institutional Review Board (IRB) and informed consent issues, participating in investigator recruitment and site selection visits, collecting and verifying essential regulatory documents, and site personnel training
Ensuring timely and accurate shipment of clinical supplies to study sites
Conducting periodic monitoring activities with the investigative sites, including reviewing case report forms (CRFs), performing source document verification, monitoring compliance with good clinical practice (GCP) guidelines and FDA regulations, and monitoring drug accountability
Coordinating the preparation of SAE reports and ensuring SAEs are reported appropriately
Conducting in-house monitoring of adverse experiences and other functions required for managing clinical trial conduct
Tracking patient recruitment, dealing with patient recruitment issues and developing site recruitment tools
Reviewing CRFs received in-house and performing data clarification functions
Conducting study closeout activities
Preparing site visit reports and follow-up letters
Actively communicating with clinical team members, including participation in team meetings and updates
Experience/Minimum Requirements
Ability to learn and follow LRA policies and procedures and all relevant SOPs (LRA, sponsor)
Knowledge and understanding of relevant FDA regulations/guidelines and principles/methods of clinical research
Accuracy and quality in the performance of all duties
Attention to detail
Ability to work effectively in a team setting
Initiative
Planning and organization skills
Excellent oral, written, and interpersonal communication skills
Judgement/problem solving skills
Computer experience (e.g., MS Word, Excel, and Outlook)
Time management and ability to meet deadlines
Ability to work independently
Productivity, flexibility, and creativity
Education/Degree
Bachelor’s degree in life or health science, or equivalent in education and relevant experience, with a minimum of two years experience as CRA (must be in field monitoring). We would prefer to see candidates with CNS experience
(3630)
