A global pharmaceutical company based in Southern California is looking to add a talented Senior Clinical Trial Specialist to its team! My client focuses on oncology and rare disease therapeutics.
My client has a very diverse pipeline including studies in phases 1-4 at present. Their therapeutic areas of focus include oncology and rare diseases. In order to support their bustling pipeline, my client is looking to add talented Clin Ops professionals to its team!
Responsibilities for the Senior CTS include:
Coordinate and participate in study meetings; i.e. study team meetings, vendor meetings, etc.
Distribute study agendas, take meeting minutes, report out minutes to the appropriate study team members
Review CRO-generated reports, elevate any deviation or protocol issues to Trial Manager to determine escalation
Support cross-functional study teams by ensuring timely and effective project tracking and administrative support of clinical research studies
Support quality assurance tasks such as ensuring audit-readiness of clinical trial study documents
Develop site clinical information communications such as study updates and newsletters
Ensure ICH/GCP guidelines and trial SOPs are being met in the execution of clinical trials
BA or BS in a life sciences field preferably
3+ years minimum clinical research experience with an INDUSTRY SPONSOR company
Knowledge of ICH GCP regulations, SOPS and internal tracking systems
Effective interpersonal and communication skills
Flexibility and adaptability within a highly dynamic clinical environment
Ability to work independently as well as part of a team
Ability to build and maintain successful professional relationships with vendors, other staff and investigators
Experience with TMF maintenance and management
Organization skills, with a detail-oriented nature
Experience interacting internal and external study stakeholders
There is an URGENT need for these opportunities to be filled, and interviews are being conducted as soon as this week. Don't hesitate to apply TODAY!