Description
Duties:-
Responsible for the implementation of clinical trial activities as defined by the Study Management Team. Works closely with investigative site personnel, CROs, and other study vendors under the direction of a Sr. CRA or CPM. -
Works with Medical Monitor and CPM or Study Lead to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies. -
May act as the lead for a region in a global trial or as part of a regional team. -
Performs the activities associated with the implementation and monitoring of clinical trials such as assisting with the development of study plans, study tools, and training materials. -
Assists in defined aspects of clinical trials at Medivation to ensure trials are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. -
Oversees drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies. -
Assists with preparation and maintenance of study drug forecast, as needed. -
Maintains study timelines. Identifies and communicates trial issues that will impact budget, resources and/or timelines. -
Participate in site monitoring and/or co-monitoring activities, as needed. -
Experience reviewing monitoring reports and monitoring visit letters is required. -
Reviews and critiques electronic CRFs for accuracy and completeness. Oversees data discrepancy management and training as needed. -
Assists with training for internal and external CRAs, CRO team members, and investigative site staff. -
Ensures that supportive study documents are completed (e.g., IXRS specification documents, specific IXRS scripts, non-clinical supply materials). -
Able to independently prioritize tasks on a day to day basis. -
Able to complete tasks with minimal supervision; able to escalate to manager if goals are in danger of being unmet. -
Contributes to wider organizational goals and/or activities as assigned.
Requirements:
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3-5 years industry experience in drug development, including prior site monitoring experience. -
Phase III Urology or Oncology experience preferred but not required. -
Previous on-site monitoring experience is preferred. -
Global trial and CRO management experience is preferred. -
Proficiency with word processing, spreadsheet, database, and presentation software (MSOffice skills such as Outlook, Word, Excel, PowerPoint) and with filing systems; Computer skills should be relevant to job roles and tasks required.
To find out more about Real please visit www.realstaffing.com