The Clinical Study Specialist (CSS) plays a crucial role in supporting the clinical study team responsible for executing clinical trials. This includes providing technical and administrative assistance to ensure seamless trial execution.
Key Responsibilities:
* Organize and deliver actionable 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
* Compile data for assessments such as feasibility and site selection, and review site usability databases
* Contribute to the review of study documents, including informed consent forms, case report forms, and facilitate study document reviews per company standard operating procedures
* Maintain and update study manuals, including study reference binders and manuals, and 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 the monitoring plan
* Monitor and update investigator/site status for the trial, and support clinical trial registry postings
* Perform scheduled reconciliations of the study Trial Master File (TMF) with clinical study lead guidance
* Ensure timely receipt of scheduled reports (e.g., 1572 reportable changes, financial disclosure form)
* 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)
* Oversee Third-Party Vendors (TPV), as assigned
* Track and monitor close-out activities, including study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
* Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives
* Recommend process improvement initiatives for the department
About the Role:
* You will be working closely with the clinical study team to execute clinical trials.
* You will be responsible for maintaining accurate records and ensuring compliance with regulatory requirements.
* You will be working in a fast-paced environment, so strong organizational and problem-solving skills are essential.
Requirements:
* Bachelor's degree with 2+ years of relevant pharmaceutical industry experience or equivalent combination of education and experience
* Demonstrated attention to detail and ability to track information
* Strong communication and interpersonal skills; ability to form relationships internally and externally
* Resourceful and able to demonstrate problem-solving skills
* Able to assess information and investigate impact on clinical trials