Senior Clinical Research Associate positions open for a Biotechnology client.
Must Have Biotech experience
Oncolytic virus, Oncology rare disease, Car-T Car-B, or Cell and Gene Therapy
Phases I-IV Trial experience
POSITION OVERVIEW
The ideal CRA will monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. S/he will support the clinical project team and study activities including site communications such as newsletters and teleconferences, development of study training and tools, and vendor oversight.
RESPONSIBILITIES
- Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines
- Assist in the review and /or development of clinical trial documents such as study plans and training materials
- Participate in and assist with facilitation of project team meetings
- Assist with the development of study communications such as study newsletters
- Assist with essential documents collection, review and archiving (TMF management)
- Provide project management support for PTX project team, including vendor oversight
- Assist with identification and selection of clinical trial sites; participate in or conduct Site Evaluation Visits
- Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports
