Job Description
The Clinical Study Specialist provides technical and administrative support to the clinical study team responsible for clinical trial execution.
* Main Responsibilities:
* Organize and deliver analyzable reports and metrics to the clinical study lead
* Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings
* Collate data for assessments such as feasibility and site selection and review site usability database
* Contribute to review of study documents such as informed consent forms, case report forms, and facilitate study document reviews per company standard operating procedures
* Compile study manuals, including but not limited to study reference binders and manuals, and maintain versioning of study reference materials
* Collate materials for training and investigator meetings
* Track site activation, enrollment, and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
* Monitor and update investigator/site status for the trial, and support with clinical trial registry postings
* Perform scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
* Ensure scheduled reports are received
* Manage and maintain team SharePoint and/or shared drive sites, as needed
* Communicate with sites as directed and maintain site contact information
* Contribute to line listings review for Blind Data Review Meeting (BDRM)
* May manage or contribute to oversight of Third-Party Vendors (TPV)
* Track and monitor close-out activities - study close-out documents and CRA close-out visits
* Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives
* Proactively recommend process improvement initiatives for the department
Requirements
* Bachelor's degree with 2+ years of relevant pharmaceutical industry experience
* In lieu of a Bachelor's Degree, 5+ years of relevant pharmaceutical industry experience is required with a focus in clinical operations or trial management
Estimated Salary Range
$60,000 - $90,000 per year